Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 Oh, Liz. I sooo agree. You are far too valuable to fall victim to this dragon. You are a shining example to strength for the people on this site. I also realize that the quality of life is important. I just deeply hate to see you give up. I hope and pray for something to come up for you. Sharon Re: Re: to Liz OT 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 .. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 Oh, Liz. I sooo agree. You are far too valuable to fall victim to this dragon. You are a shining example to strength for the people on this site. I also realize that the quality of life is important. I just deeply hate to see you give up. I hope and pray for something to come up for you. Sharon Re: Re: to Liz OT 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 .. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 Who is going to drive me if Daymon is out of town (which is quite allot ,lol) ? 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 I know sweetie and your prayers are appreciated 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...
Guest guest Posted February 5, 2007 Report Share Posted February 5, 2007 I'm to dang spunky to give in to the dragon ,, Re: Re: to Liz OT well so be it if it would help you,, I'd travel to the other side of the world if it would help!elizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Being here in Vegas there are no tp centers , I would have to really travel far .. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 6, 2007 Report Share Posted February 6, 2007 Please count me on the list of those ready to jump in and help you in any way I can, Liz. Your strength and commitment to helping are incredible and my prayers for that right match of care for you are constant. love, karen > Coley Suspends Development of HCV Toll-Receptor Drug > > Coley Pharmaceutical Group Updates Hepatitis C Drug Development > Strategy > > Coley press release > January 23, 2007 - 6:56 AM > > Company Suspends Independent Development of ACTILON; Concentrates > Efforts on Preclinical TLR Therapeutics Product Candidates > > Coley Reduces In-house Drug Development Staff > > " â?¦.. the competitive landscape for the naive patients is rapidly > evolving, making drug development complex, expensive and high > riskâ?¦..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 clearâ?¦. " > > 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 Status > > Coley'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 Group > > Coley 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 Email > Stay connected with on your mobile. Get started! > > > > Jackie > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 6, 2007 Report Share Posted February 6, 2007 Thank you sweety ! Re: to Liz OT Please count me on the list of those ready to jump in and help you in any way I can, Liz. Your strength and commitment to helping are incredible and my prayers for that right match of care for you are constant. love, karen > Coley Suspends Development of HCV Toll-Receptor Drug> > Coley Pharmaceutical Group Updates Hepatitis C Drug Development > Strategy> > Coley press release> January 23, 2007 - 6:56 AM> > Company Suspends Independent Development of ACTILON; Concentrates > Efforts on Preclinical TLR Therapeutics Product Candidates> > Coley Reduces In-house Drug Development Staff> > "â?¦.. the competitive landscape for the naive patients is rapidly > evolving, making drug development complex, expensive and high > riskâ?¦..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 clearâ?¦."> > 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 Status> > Coley'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 Group> > Coley 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 Email> Stay connected with on your mobile. Get started! > > > > Jackie> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 6, 2007 Report Share Posted February 6, 2007 Daymon would drive you if you needed a liver and there was one available,, c'mon, nothing is more important to him,, that I KNOW!elizabethnv1 <elizabethnv1@...> wrote: Who is going to drive me if Daymon is out of town (which is quite allot ,lol) ? 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 Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 6, 2007 Report Share Posted February 6, 2007 He is gone on business allot sooo I would be screwed lol 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 Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 7, 2007 Report Share Posted February 7, 2007 well IF YOUR LIFE depended on him being there WITH YOU, he'd do that,, I KNOW THAT! Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 7, 2007 Report Share Posted February 7, 2007 well IF YOUR LIFE depended on him being there WITH YOU, he'd do that,, I KNOW THAT! Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 7, 2007 Report Share Posted February 7, 2007 Jackie , I know that but work is an absolute necessity cause without it there would be no insurance . Re: Re: to Liz OT well IF YOUR LIFE depended on him being there WITH YOU, he'd do that,, I KNOW THAT! Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 Ok, I give upelizabethnv1 <elizabethnv1@...> wrote: Jackie , I know that but work is an absolute necessity cause without it there would be no insurance . Re: Re: to Liz OT well IF YOUR LIFE depended on him being there WITH YOU, he'd do that,, I KNOW THAT! Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 There is hope for all things as long as their is life.. Circumstances can change, as can mindsets, prayers can and do help, as well.. Liz will do what is best for her family and herself, of that much I feel certain, she's already a fighter and a Dragon Slayer.. Sometimes we just get tired and need a rest from it all.. Hugs and Prayers, Sheena Jackie on <redjaxjm@...> wrote: Ok, I give upelizabethnv1 <elizabethnv1earthlink (DOT) net> wrote: Jackie , I know that but work is an absolute necessity cause without it there would be no insurance . . We won't tell. Get more on shows you hate to love(and love to hate): TV's Guilty Pleasures list. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 I don't know if this is a feasible idea or not, it popped into my head while I was babysitting my mouth during the night. I know there are huge networks of volunteers who will gladly transport puppies, in legs of the journey, across the USA. Only the cost of the gas is involved. Why couldn't this work for Heppers as well? Sometimes we NEED to get somehwere else for medical treatment and don't have a way to do that. With all the organizations, support groups and millions of heppers, why couldn't a network of volunteers be set up for people? I know there are sooo many compassionate caring people in our world who would gladly help someone like Liz get to the place she needs to be for a transplant. In my Mind, it works. Will you moderators and intelligent members give this a critical think? Sharon There is hope for all things as long as their is life.. Circumstances can change, as can mindsets, prayers can and do help, as well.. Liz will do what is best for her family and herself, of that much I feel certain, she's already a fighter and a Dragon Slayer.. Sometimes we just get tired and need a rest from it all.. Hugs and Prayers, Sheena Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 What a beautiful idea, Sharon, I know many of my animal friends would happily transport a Liz.. or anyone else in that kind of need.. I'll tell you even I could have used a ride home from my Cat Scan, they used enough iodine to float a boat.. :-o Hugs, Sheena SHARON CROSBY <csharonxoxo@...> wrote: I don't know if this is a feasible idea or not, it popped into my head while I was babysitting my mouth during the night. I know there are huge networks of volunteers who will gladly transport puppies, in legs of the journey, across the USA. Only the cost of the gas is involved. Why couldn't this work for Heppers as well? Sometimes we NEED to get somehwere else for medical treatment and don't have a way to do that. With all the organizations, support groups and millions of heppers, why couldn't a network of volunteers be set up for people? I know there are sooo many compassionate caring people in our world who would gladly help someone like Liz get to the place she needs to be for a transplant. In my Mind, it works. Will you moderators and intelligent members give this a critical think? Sharon There is hope for all things as long as their is life.. Circumstances can change, as can mindsets, prayers can and do help, as well.. Liz will do what is best for her family and herself, of that much I feel certain, she's already a fighter and a Dragon Slayer.. Sometimes we just get tired and need a rest from it all.. Hugs and Prayers, Sheena Need a quick answer? Get one in minutes from people who know. Ask your question on Answers. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 lol I knew you would cave in ....hehehehe dont worry honey when the time comes who knows how I will feel about it . Re: Re: to Liz OT well IF YOUR LIFE depended on him being there WITH YOU, he'd do that,, I KNOW THAT! Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 lol I knew you would cave in ....hehehehe dont worry honey when the time comes who knows how I will feel about it . Re: Re: to Liz OT well IF YOUR LIFE depended on him being there WITH YOU, he'd do that,, I KNOW THAT! Jackie Jackie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 You know what that is such an excellent ideal ! I know there are networks out there for patients with hiv , but there should be some for us too ! Re: Re: to Liz OT I don't know if this is a feasible idea or not, it popped into my head while I was babysitting my mouth during the night. I know there are huge networks of volunteers who will gladly transport puppies, in legs of the journey, across the USA. Only the cost of the gas is involved. Why couldn't this work for Heppers as well? Sometimes we NEED to get somehwere else for medical treatment and don't have a way to do that. With all the organizations, support groups and millions of heppers, why couldn't a network of volunteers be set up for people? I know there are sooo many compassionate caring people in our world who would gladly help someone like Liz get to the place she needs to be for a transplant. In my Mind, it works. Will you moderators and intelligent members give this a critical think? Sharon There is hope for all things as long as their is life.. Circumstances can change, as can mindsets, prayers can and do help, as well.. Liz will do what is best for her family and herself, of that much I feel certain, she's already a fighter and a Dragon Slayer.. Sometimes we just get tired and need a rest from it all.. Hugs and Prayers, Sheena Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 Thanks! I do hope you can work it into something good, Liz, with your connections with other groups. It COULD be a good thing. Sharon You know what that is such an excellent ideal ! I know there are networks out there for patients with hiv , but there should be some for us too ! I don't know if this is a feasible idea or not, it popped into my head while I was babysitting my mouth during the night. I know there are huge networks of volunteers who will gladly transport puppies, in legs of the journey, across the USA. Only the cost of the gas is involved. Why couldn't this work for Heppers as well? Sometimes we NEED to get somehwere else for medical treatment and don't have a way to do that. With all the organizations, support groups and millions of heppers, why couldn't a network of volunteers be set up for people? I know there are sooo many compassionate caring people in our world who would gladly help someone like Liz get to the place she needs to be for a transplant. In my Mind, it works. Will you moderators and intelligent members give this a critical think? Sharon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 8, 2007 Report Share Posted February 8, 2007 Thanks! I do hope you can work it into something good, Liz, with your connections with other groups. It COULD be a good thing. Sharon You know what that is such an excellent ideal ! I know there are networks out there for patients with hiv , but there should be some for us too ! I don't know if this is a feasible idea or not, it popped into my head while I was babysitting my mouth during the night. I know there are huge networks of volunteers who will gladly transport puppies, in legs of the journey, across the USA. Only the cost of the gas is involved. Why couldn't this work for Heppers as well? Sometimes we NEED to get somehwere else for medical treatment and don't have a way to do that. With all the organizations, support groups and millions of heppers, why couldn't a network of volunteers be set up for people? I know there are sooo many compassionate caring people in our world who would gladly help someone like Liz get to the place she needs to be for a transplant. In my Mind, it works. Will you moderators and intelligent members give this a critical think? Sharon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 9, 2007 Report Share Posted February 9, 2007 That would take allot of work to coordinate and I just don't think I have it in me . The energy factor is so low lately ... Re: Re: to Liz OT Thanks! I do hope you can work it into something good, Liz, with your connections with other groups. It COULD be a good thing. Sharon You know what that is such an excellent ideal ! I know there are networks out there for patients with hiv , but there should be some for us too ! I don't know if this is a feasible idea or not, it popped into my head while I was babysitting my mouth during the night. I know there are huge networks of volunteers who will gladly transport puppies, in legs of the journey, across the USA. Only the cost of the gas is involved. Why couldn't this work for Heppers as well? Sometimes we NEED to get somehwere else for medical treatment and don't have a way to do that. With all the organizations, support groups and millions of heppers, why couldn't a network of volunteers be set up for people? I know there are sooo many compassionate caring people in our world who would gladly help someone like Liz get to the place she needs to be for a transplant. In my Mind, it works. Will you moderators and intelligent members give this a critical think? Sharon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 9, 2007 Report Share Posted February 9, 2007 I have horrific brain fog, but would sure be willing to help as much as possible. elizabethnv1 <elizabethnv1@...> wrote: That would take allot of work to coordinate and I just don't think I have it in me . The energy factor is so low lately ... Re: Re: to Liz OT Thanks! I do hope you can work it into something good, Liz, with your connections with other groups. It COULD be a good thing. Sharon You know what that is such an excellent ideal ! I know there are networks out there for patients with hiv , but there should be some for us too ! I don't know if this is a feasible idea or not, it popped into my head while I was babysitting my mouth during the night. I know there are huge networks of volunteers who will gladly transport puppies, in legs of the journey, across the USA. Only the cost of the gas is involved. Why couldn't this work for Heppers as well? Sometimes we NEED to get somehwere else for medical treatment and don't have a way to do that. With all the organizations, support groups and millions of heppers, why couldn't a network of volunteers be set up for people? I know there are sooo many compassionate caring people in our world who would gladly help someone like Liz get to the place she needs to be for a transplant. In my Mind, it works. Will you moderators and intelligent members give this a critical think? Sharon The fish are biting. Get more visitors on your site using Search Marketing. Quote Link to comment Share on other sites More sharing options...
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