Guest guest Posted November 7, 2008 Report Share Posted November 7, 2008 Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 9, 2008 Report Share Posted November 9, 2008 Try a high fiber cereal which is what works well for me . I eat cinamon life it even tastes good lol Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_Central Date: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 9, 2008 Report Share Posted November 9, 2008 Weekly with pills. Its for 48 weeks. Thanks Subject: RE: Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_Central Date: Tuesday, November 11, 2008, 4:33 AM Are you doing the weekly or the daily injections? Unfortunately, everyone¢s reaction to treatment is different. I worked most of the time my first treatment, but have not been able to work during this third attempt at SVR. See a psychiatrist for your anti-depressant, they know more than general practitioners (usually). It sounds like an SSRI is good if you didn¢t need meds before; Interferon can deplete serotonin. For constipation, I was using Miralx, which was prescription, but is now OTC. The doc switched me to lactulose because of my hep enceph, so if your doc will write a script, that one is supposed to be better on the liver. From: Hepatitis_C_ Central@yahoogro ups.com [mailto:Hepatitis_ C_Central@ yahoogroups. com] On Behalf Of ElderSent: Sunday, November 09, 2008 7:51 AMTo: Hepatitis_C_ Central@yahoogro ups.comSubject: Re: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results Hi everyone, I just got back from Mexico. Every morning with my coffee on the ship I read all of your e-mails. Thank you to and Janet on keeping me very informed. I tuned into this format to learn and share ideas, hopes and support. I will be starting interferon this Thursday. Countdown days - 5..........I have been very emotional and cried every day. I will take someones advise and ask for some sort of anti depressant to help get through the blues. I am mourning my old life and I am scared that the treatment will make me sick ( I never ever get sick)....... .worst of all I am afraid of any sort of depression setting in. Because I have such low iron they have put me on a prescription iron pill. It is so hard on my stomach and causes awful constipation. ......... any solutions? Also if I start on Thursday with the injections and then down the road due to my work schedule I need to change the day to Friday will that be a big problem? I go to a class tomorrow to learn how to inject myself. I have Geno 1-A and the onset of cirrhosis so I am praying this will work. My liver doctor is supposed to be the best we have here in southern California. He says 48 weeks but that if the virus is not 100% gone in 3 months they take me off the injections because I would be a non-responder. .....then I just nurture the liver as best I can and at some point down the road get put on a transplant list. I have two children to fight for - 11 and 17. I also have a wonderful full life. I need for this to work. I did not drink for 25 years, then 5 years ago I started because I didnt think it would be a probelm. I no longetr drink....... .....but if I had never taken that 5 year break in sobrity then this would of been a slower process. Its a hard lesson to learn. I dont want to just take and not give so if anyone needs any advise or help from me please let me know. I would appreciate if someone can share some experinece about their treatment with the interferon. I have a business I started 18 months ago and am really hoping I can still go to work at least 3 days a week? By the way, I have had hep c for 30 years and I am 52. I have really never had symptoms until 7 months ago when I noticed my spleen was swollen. Blood work was always good. I was married 17 years and he never got hep c from from me. I have a new husband and we have been together 3 years and he hasnt either. I think it is almost impossible to get it through sex. I am sure there are rare cases but its not the norm. I also have had a c section and reg birth and Imy kids do not have it. Thanks again, Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 11, 2008 Report Share Posted November 11, 2008 Are you doing the weekly or the daily injections? Unfortunately, everyone’s reaction to treatment is different. I worked most of the time my first treatment, but have not been able to work during this third attempt at SVR. See a psychiatrist for your anti-depressant, they know more than general practitioners (usually). It sounds like an SSRI is good if you didn’t need meds before; Interferon can deplete serotonin. For constipation, I was using Miralx, which was prescription, but is now OTC. The doc switched me to lactulose because of my hep enceph, so if your doc will write a script, that one is supposed to be better on the liver. From: Hepatitis_C_Central [mailto:Hepatitis_C_Central ] On Behalf Of Elder Sent: Sunday, November 09, 2008 7:51 AM To: Hepatitis_C_Central Subject: Re: Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results Hi everyone, I just got back from Mexico. Every morning with my coffee on the ship I read all of your e-mails. Thank you to and Janet on keeping me very informed. I tuned into this format to learn and share ideas, hopes and support. I will be starting interferon this Thursday. Countdown days - 5..........I have been very emotional and cried every day. I will take someones advise and ask for some sort of anti depressant to help get through the blues. I am mourning my old life and I am scared that the treatment will make me sick ( I never ever get sick)........worst of all I am afraid of any sort of depression setting in. Because I have such low iron they have put me on a prescription iron pill. It is so hard on my stomach and causes awful constipation..........any solutions? Also if I start on Thursday with the injections and then down the road due to my work schedule I need to change the day to Friday will that be a big problem? I go to a class tomorrow to learn how to inject myself. I have Geno 1-A and the onset of cirrhosis so I am praying this will work. My liver doctor is supposed to be the best we have here in southern California. He says 48 weeks but that if the virus is not 100% gone in 3 months they take me off the injections because I would be a non-responder......then I just nurture the liver as best I can and at some point down the road get put on a transplant list. I have two children to fight for - 11 and 17. I also have a wonderful full life. I need for this to work. I did not drink for 25 years, then 5 years ago I started because I didnt think it would be a probelm. I no longetr drink............but if I had never taken that 5 year break in sobrity then this would of been a slower process. Its a hard lesson to learn. I dont want to just take and not give so if anyone needs any advise or help from me please let me know. I would appreciate if someone can share some experinece about their treatment with the interferon. I have a business I started 18 months ago and am really hoping I can still go to work at least 3 days a week? By the way, I have had hep c for 30 years and I am 52. I have really never had symptoms until 7 months ago when I noticed my spleen was swollen. Blood work was always good. I was married 17 years and he never got hep c from from me. I have a new husband and we have been together 3 years and he hasnt either. I think it is almost impossible to get it through sex. I am sure there are rare cases but its not the norm. I also have had a c section and reg birth and Imy kids do not have it. Thanks again, Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 11, 2008 Report Share Posted November 11, 2008 Hi , who is your Dr in Southern CA and what city is he in? Please be sure that you drink lots of water (1/2 your body weight in ounces) and that you eat. One of my problems while on TX was that I stopped eating except for fruit and some crackers. NOT THE THING TO DO!! Steph From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_ Central@yahoogro ups.comDate: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 11, 2008 Report Share Posted November 11, 2008 Hi , I just got back from the doctors. This group really helps. told me to have them test me for a Celtic Panel (not the right spelling) and they are going to. I asked about the iron that the blood doctor put me on and he took me off it. My gastro is Dr Stanton and his office is in Orange and Irvine. I have put weight on the last 8 months and he said it is from the liver and it will start to go away when I start treatment. Thats my silver lining! From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_ Central@yahoogro ups.comDate: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 11, 2008 Report Share Posted November 11, 2008 Oh Im thrilled he took you off the Iron.... Im not so sure that the weight is all liver related,, I have not found that to be so in my case anyway,, and I eat one meal per day and I am still obese.. even my husband goes in with me to see my doc and he tries to get me to eat, I have no appetite, Im virus free now 5 1/2 years and I still cannot lose weight.. we're thinking it might be my thyroid now,,,, who knows.. but IM really really did I say REALLY glad he took you off the Iron,, and I hope he realizes that he 'may' have compromised your health and your ability to clear the virus... From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_ Central@yahoogro ups.comDate: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 12, 2008 Report Share Posted November 12, 2008 Im glad he took me off to. It was really hard on my stomach. He didnt put me on it the hemotoligist did. So now I have to make sure the left hand knows what the right hand is doing. When you work so closely with 2 doctors they sometimes give you conflicting instructions. I dont think all the weight will come off but I do think that I am retaining alot of fluid. Heck even a few freebie pounds are great to lose! From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_ Central@yahoogro ups.comDate: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 14, 2008 Report Share Posted November 14, 2008 , I wish you well during treatment!!!! Steph From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_ Central@yahoogro ups.comDate: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 14, 2008 Report Share Posted November 14, 2008 Thank you! From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_ Central@yahoogro ups.comDate: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 14, 2008 Report Share Posted November 14, 2008 EXACTLY.. thats just another issue we all have to deal with.. make sure your docs know all the meds, vitamins, supplements etc you're one,, From: <elizabethnv1@ earthlink. net>Subject: [Hepatitis_C_ Central] Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics ResultsTo: Hepatitis_C_ Central@yahoogro ups.comDate: Friday, November 7, 2008, 11:33 PM Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov 01, 2008 -- Anadys Pharmaceuticals, Inc. (ANDS: anadys pharmaceuticals inc ANDS 2.19, -0.09, -3.9%) announced today the results of a Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that support ANA598 as one of the leading non-nucleoside polymerase inhibitors currently in development for the treatment of HCV. These results are being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco, California, from October 31 - November 4. ANA598 is the Company's investigational hepatitis C non- nucleoside polymerase inhibitor. ANA598 Phase I Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study, although definitive conclusions regarding product safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. All reported adverse events were classified as mild or moderate, with no apparent dose relationship and no pattern of events within any body system. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 with a half-life of 24 to 30 hours in the fasted state and 22 hours in the fed state, consistent with the potential for once-daily or twice-daily oral dosing. In the cohort that received two 800 mg doses 12 hours apart, the concentration of ANA598 in plasma 12 hours after the second dose was 83 ug/mL, which substantially exceeds the level predicted to display antiviral potency. The data will be presented in a late-breaker poster titled "Results of a Phase I Safety, Tolerability and Pharmacokinetic Study of ANA598, a Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers", at 1:00 p.m. PST on Monday, November 3. ANA598 Preclinical Data at AASLD Meeting In addition to the results of the Phase I healthy volunteer study, Anadys is presenting additional data on the preclinical profile of ANA598 at the AASLD Meeting on Tuesday, November 4. -- In a poster titled "In Vitro Studies Demonstrate that Combinations of Antiviral Agents that Include HCV Polymerase Inhibitor ANA598 have the Potential to Overcome Viral Resistance", Anadys will present the results of in vitro studies that show ANA598 to be synergistic with interferon-alpha, the protease inhibitor telaprevir (VX-950), and the nucleoside polymerase inhibitor PSI-6130 (the active agent of R7128). These studies also show that ANA598 retains activity against mutants known to confer resistance to other classes of direct antivirals, including protease inhibitors, nucleoside inhibitors and non-nucleosides that bind at the thumb site. Genotypic mutations resistant to ANA598 will be shown to be fully susceptible to interferon-alpha, telaprevir (VX-950) and PSI-6130. Data will also be presented demonstrating synergy between ANA598 and cytokines induced by ANA773, Anadys' TLR7 agonist oral prodrug, also in development for hepatitis C. These data strongly support the potential for ANA598 to be used in combination with multiple other agents approved or under investigation for hepatitis C. -- In a poster titled "Antiviral Efficacy of the HCV RNA Polymerase Inhibitor ANA598 in the Chimpanzee Model of HCV Infection", Anadys will present data showing that ANA598 exhibits a substantial antiviral effect against both genotype 1a and 1b. In two HCV genotype 1b animals dosed over four days, maximum viral load reductions of 2.2 and 2.6 log10 were observed within 24 to 48 hours after the initial dose. In one animal the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four. In two HCV genotype 1a animals that each received a single dose of ANA598, viral load reductions of 0.5 and 1.4 log10 were seen at 48 hours post-dose. About ANA598 Anadys recently initiated patient dosing in a Phase Ib study of ANA598 in HCV patients. Naive genotype 1a and 1b patients will receive ANA598 over three days at doses of 200 mg bid (twice-a-day) , 400 mg bid or 800 mg bid. Ten patients will be enrolled at each dose level, eight receiving active drug and two receiving placebo. Anadys recently completed dosing in the Phase I study of ANA598 in healthy volunteers. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical trials, it is anticipated that the acceleration of these and other non-clinical activities into 2008 will enable a more rapid and continuous development path into Phase II studies during 2009. Clinical Need and Market Opportunity in HCV Infection Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated. About Anadys Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer. Quote Link to comment Share on other sites More sharing options...
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