Guest guest Posted October 15, 2005 Report Share Posted October 15, 2005 Well its over now,, I have emailed him privately to see if it really IS bill or someone else on his computer, I dont know,, elizabethnv1 <elizabethnv1@...> wrote:It has been entertaining to say the least and a little irratating . This guy wouldnt stop all day ........ It's not about > > money. > > > > > > > > > > > > As I said on my previous post, I am an Ambassador > > for One Legacy, > > the > > > So CA Organ Procurement Network. The same network > > that governs St > > > 's....so before someone else posts this > > article and Ric says > > > that it's all about money,....and I get a few > > emails asking me how > > I > > > can be part of something so " turbid " ....I thought > > I'd post it > > > myself.....and tell you that for some of us....it > > really isn't > > about > > > money. > > > > > > It's not about money when we go stand in the sun > > for health fairs, > > > walks and runs and tournaments or whatever it is > > we're helping > > with > > > this week. It isn't about money when we give up > > our Saturday so we > > > can be at the local mall's organ donation booth > > encouraging > > strangers > > > to consider donation.....and it sure as hell isn't > > about money when > > > we go decorate the Rose parade organ donaion float > > and have to put > > > our hands in uice water to get the flowers, or > > climb up high even > > > though we;re scared and somehow always end up with > > glue on our hair > > > that we can't remove for days. > > > > > > I do this to build a net for those of you wqho > > don't clear....it > > > isn't perfect but that's all we have....and it is > > so much more than > > > money.... > > > > > > Silvia > > > > > > > > > > > > > > > > > > > > > Deception Behind Liver-Transplant Switch Proved to > > Be Fatal > > > > > > By Ornstein and Alan Zarembo > > > Times Staff Writers > > > > > > October 13, 2005 > > > > > > In January 2003, after more than two years on a > > waiting list for a > > liver > > > transplant, Saad Al-Harthi was finally considered > > sick enough to > > rank near > > > the top. > > > > > > If a donated organ became available, he would have > > only a few hours > > to get > > > to St. Medical Center in Los Angeles. > > > > > > But that same month, Dr. R. Jr., > > then-director of the > > > hospital's liver transplant program, told him he > > faced a long wait > > and was > > > better off at home in Saudi Arabia, according to > > Al-Harthi's son > > Majed. > > > > > > That's where he was Sept. 8, 2003, when the > > hospital accepted a > > liver in his > > > name. > > > > > > and Dr. Ramos, his assistant > > director, transplanted > > the organ > > > into another Saudi national 50 places behind him > > on the list, > > > St. > > > officials now acknowledge. The > > misallocation, reported by > > The Times > > > last month, is a serious breach of the national > > code governing > > placement of > > > donated organs. > > > > > > Al-Harthi never knew any of this. He died less > > than > === message truncated === > > > > > > __________________________________ > - PC Magazine Editors' Choice 2005 > http://mail. > It's a pleasure having you join in our conversations. We hope you have found the support you need with us. If you are using email for your posts, for easy access to our group, just click the link-- Hepatitis C/ Happy Posting Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 14, 2006 Report Share Posted September 14, 2006 well it looks like and I will have to fly to Oregon and drive all of 's and Marks things back down here as his parents have had a hitch in their gitalong and can't come. They both are working so it would be easier if Rog and I went there,, so I dont know when we can come but I hope it will be soon,, I will get the cheesecake made and frozen and then get it shipped overnite to ya,, love you honey, jackieelizabethnv1 <elizabethnv1@...> wrote: Why don't you and just bring it ?? hehe I miss you and our last visit was so short . Almost as short as the visit I had with Lo from the car rental place to the airport ,lol about 10minutes Re: Sorry about the flood of information we love ya Liz,, thanks so much for researching for us and getting all the great info to us,, love you! meelizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: I get information and usually pass it on immediately but lately with my computer down it has backed up . So I am sorry if I have flooded your senses with information folks but if I don't get it out I will forget all about it , lol Some of the information is informative while other info may be not as usefull , I would be derelict in my duties if I didn't post it all . Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 14, 2006 Report Share Posted September 14, 2006 You can mail it if ya like , but I was just hoping to see you guys Seems like for the last couple of years you two have had your hands full . Luv ya Re: Sorry about the flood of information we love ya Liz,, thanks so much for researching for us and getting all the great info to us,, love you! meelizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: I get information and usually pass it on immediately but lately with my computer down it has backed up . So I am sorry if I have flooded your senses with information folks but if I don't get it out I will forget all about it , lol Some of the information is informative while other info may be not as usefull , I would be derelict in my duties if I didn't post it all . Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 15, 2006 Report Share Posted September 15, 2006 Oh yeah,, I WOULD LOVE to come down and see you guys... We ARE going to do it one of these days,, just can't tell ya when... I have my plate very full right now,, Im tired of it too,, lol... I love ya!elizabethnv1 <elizabethnv1@...> wrote: You can mail it if ya like , but I was just hoping to see you guys Seems like for the last couple of years you two have had your hands full . Luv ya Re: Sorry about the flood of information we love ya Liz,, thanks so much for researching for us and getting all the great info to us,, love you! meelizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: I get information and usually pass it on immediately but lately with my computer down it has backed up . So I am sorry if I have flooded your senses with information folks but if I don't get it out I will forget all about it , lol Some of the information is informative while other info may be not as usefull , I would be derelict in my duties if I didn't post it all . Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 15, 2006 Report Share Posted September 15, 2006 Still takin care of dad ? How is mom doing in the new place ? Oh I am back on im with the same im elizabethnv1 . New hard drive with logs of megabytes to use ,lol Re: Sorry about the flood of information we love ya Liz,, thanks so much for researching for us and getting all the great info to us,, love you! meelizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: I get information and usually pass it on immediately but lately with my computer down it has backed up . So I am sorry if I have flooded your senses with information folks but if I don't get it out I will forget all about it , lol Some of the information is informative while other info may be not as usefull , I would be derelict in my duties if I didn't post it all . Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2007 Report Share Posted February 1, 2007 Thanks hon,, just got home a few min ago and had some dinner.. it took me more than an hour at k-mart hunting down different items for my mom!!! but that is much faster than taking HER there to find things! lolelizabethnv1 <elizabethnv1@...> wrote: Give my luv ta mom and dad , and Rog of course Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2007 Report Share Posted February 1, 2007 LOL ! Lo was on the Actilon meds and she says it was the most painful shot she has ever taken . Her viral went to <600 and enzymes went down but now her viral is back up . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2007 Report Share Posted February 1, 2007 dang it,, poor thing,, she has tried and tried ,, I just wish she would clear,, just like I wish you would clear too! YOU both are great ladies and deserve it!elizabethnv1 <elizabethnv1@...> wrote: LOL ! Lo was on the Actilon meds and she says it was the most painful shot she has ever taken . Her viral went to <600 and enzymes went down but now her viral is back up . ----- Original Message ----- From: Jackie on Hepatitis C Sent: Thursday, February 01, 2007 7:14 PM Subject: Re: to Liz OT Thanks hon,, just got home a few min ago and had some dinner.. it took me more than an hour at k-mart hunting down different items for my mom!!! but that is much faster than taking HER there to find things! lolelizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Give my luv ta mom and dad , and Rog of course Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2007 Report Share Posted February 1, 2007 And she has such a great attitude too ! She is my hero ,lol myself I have lost allot of hope but Lo keeps right on trucking hehe Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2007 Report Share Posted February 1, 2007 well get that dang pacemaker in then you can maybe treat again,, and make it to the clear finishline!!!elizabethnv1 <elizabethnv1@...> wrote: And she has such a great attitude too ! She is my hero ,lol myself I have lost allot of hope but Lo keeps right on trucking hehe Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2007 Report Share Posted February 1, 2007 They will not let me treat , I get monthly MELD's now for transplant . But have decided not to transplant . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 2, 2007 Report Share Posted February 2, 2007 WHY? you still have children at home who need you!elizabethnv1 <elizabethnv1@...> wrote: They will not let me treat , I get monthly MELD's now for transplant . But have decided not to transplant . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 2, 2007 Report Share Posted February 2, 2007 My baby is almost 15 by the time I reach a critical end stage she will be 18 . I am just tired of the whole thing . Unlike allot of you I was diagnosed back in the 80's with hep a and non a non b and have been battling ever since . I started having seizures again and my hepatic enceph has gotten worse . It's just time to just enjoy what time I have left instead of raging against something my body can't fight . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 2, 2007 Report Share Posted February 2, 2007 I will email my answer to THIS to you privately,, love you!elizabethnv1 <elizabethnv1@...> wrote: My baby is almost 15 by the time I reach a critical end stage she will be 18 . I am just tired of the whole thing . Unlike allot of you I was diagnosed back in the 80's with hep a and non a non b and have been battling ever since . I started having seizures again and my hepatic enceph has gotten worse . It's just time to just enjoy what time I have left instead of raging against something my body can't fight . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 3, 2007 Report Share Posted February 3, 2007 Liz, I am so very sorry for what you are going through, the decisions must be just horrendous, I can't even begin to imagine, but please know that even though I have only been with you here for 5 months, you have become important to me, like a sister. I am here for you, and don't say it often enough, I do care.. Love and Prayers, Sheena Jackie on <redjaxjm@...> wrote: WHY? you still have children at home who need you!elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: They will not let me treat , I get monthly MELD's now for transplant . But have decided not to transplant . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 3, 2007 Report Share Posted February 3, 2007 Thank you so much Sheena that means allot to me . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 4, 2007 Report Share Posted February 4, 2007 If there is anything at all I can do, Liz, you just let me know.. In the meantime, I just pray a whole lot.. Hugs and Prayers, Sheena elizabethnv1 <elizabethnv1@...> wrote: Thank you so much Sheena that means allot to me . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 4, 2007 Report Share Posted February 4, 2007 Hi Prayers, and faith, didn't I read sometime back about being able to get a partial transplant using part of someone elses liver? Is that an option? Ya'll know about the med stuff way more than I. It just seems I have read that somewhere. Good Luck dSheena <mom4possums2002@...> wrote: If there is anything at all I can do, Liz, you just let me know.. In the meantime, I just pray a whole lot.. Hugs and Prayers, Sheena elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Thank you so much Sheena that means allot to me . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Never Miss an EmailStay connected with on your mobile. Get started! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 Just keep the prayers coming ....they work ! thnx Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 It is someting I have checked into but my current hep doc won't do it . He says that the living donor can have some real problems afterwards . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Never Miss an EmailStay connected with on your mobile. Get started! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 It is someting I have checked into but my current hep doc won't do it . He says that the living donor can have some real problems afterwards . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Never Miss an EmailStay connected with on your mobile. Get started! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 they had some issues for the donor in a couple of the transplant hospitals but not all of them had these problems.. I know of a couple of transplanted heppers who used a living donor and are doing quite well.. and the donors didnt have any problem afterwards.. I think it has to be the right person, the right liver and the right docs at the right hospital... elizabethnv1 <elizabethnv1@...> wrote: It is someting I have checked into but my current hep doc won't do it . He says that the living donor can have some real problems afterwards . Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Never Miss an EmailStay connected with on your mobile. Get started! Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 Being here in Vegas there are no tp centers , I would have to really travel far .. Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Never Miss an EmailStay connected with on your mobile. Get started! Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 well so be it if it would help you,, I'd travel to the other side of the world if it would help!elizabethnv1 <elizabethnv1@...> wrote: Being here in Vegas there are no tp centers , I would have to really travel far .. Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Never Miss an EmailStay connected with on your mobile. Get started! Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 UCLA comes to mind, they do wonderful work, Liz.. You ever have my prayers.. elizabethnv1 <elizabethnv1@...> wrote: Being here in Vegas there are no tp centers , I would have to really travel far .. Re: Coley Suspends Development of HCV Toll-Receptor Drug Welcome back Liz, hope you had a great trip! Isnt this the stuff that Lefty was on?elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Coley Suspends Development of HCV Toll-Receptor DrugColey Pharmaceutical Group Updates Hepatitis C Drug Development StrategyColey press releaseJanuary 23, 2007 - 6:56 AMCompany Suspends Independent Development of ACTILON; Concentrates Efforts on Preclinical TLR Therapeutics Product CandidatesColey Reduces In-house Drug Development Staff"….. the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk…..suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear…."WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics, including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9."The decision to suspend a drug development program is a difficult one," commented L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."ACTILON Program Overview and StatusColey's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:Phase Ib clinical trial in relapsed HCV patients:* In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.* These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.* Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.Phase II clinical trial in null and partial responder HCV patients:* In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.* Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.About Coley Pharmaceutical GroupColey Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.Jackie Jackie Jackie Jackie Jackie Jackie Jackie Don't be flakey. Get for Mobile and always stay connected to friends. Everyone is raving about the all-new beta. Never Miss an EmailStay connected with on your mobile. Get started! Jackie Never Miss an EmailStay connected with on your mobile. Get started! Quote Link to comment Share on other sites More sharing options...
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