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Vertex- Telaprevir Phase 3
(This is a long article and there will be many follow-up articles. For the complete article please go to the link I provide below--- Willy)
http://biz.yahoo.com/bw/080123/20080123005338.html?.v=1
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Protease Inhibitor
Wednesday January 23, 7:00 am ET
-- Primary Phase 3 trial will focus on studying 24-week telaprevir-based regimens
-- Vertex plans concurrent second study to support registration
-- Final data from both trials anticipated in mid- 2010
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it will begin Phase 3 evaluation of telaprevir, Vertex’s lead investigational hepatitis C protease inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial that will evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naïve genotype 1 HCV patients. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks. A second study of approximately 400-500 HCV patients is planned to evaluate a 48-week telaprevir-based regimen, to confirm the results from Phase 2 studies and provide additional evidence that supports the 24-week regimen that is being evaluated in the primary Phase 3 trial. The Company expects that both studies will run concurrently and that the first trial will begin enrolling patients in March 2008.
“Data presented in late 2007 from two large Phase 2b studies suggest that telaprevir, dosed in combination with pegylated interferon and ribavirin, may be able to meaningfully increase the proportion of treatment-naïve genotype 1 HCV patients who achieve a sustained viral response, and also cut the current treatment duration in half, to 24 weeks,” said John McHutchison, M.D., Principal Investigator for the primary telaprevir Phase 3 pivotal study and Associate Director of Duke Clinical Research Institute. “Telaprevir is the most advanced protease inhibitor in development for hepatitis C, and the initiation of Phase 3 clinical development for this investigational drug will begin the process of helping to further assess its potential efficacy and the safety in a larger number of patients.”
Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens
In accordance with the design and protocol Vertex submitted to the FDA, the primary pivotal trial will focus on evaluation of 24 weeks of telaprevir-based therapy and will enroll approximately 1050 treatment-naïve, genotype 1 HCV patients, who will be randomized equally across three treatment arms (approximately 350 patients per arm).
The study will be conducted at approximately 100 centers in the U.S., E.U. and certain other countries. The study arms will include:
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone;
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks, then continuing for another 16 weeks with peg-IFN and RBV alone; and
A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.
Patients in both telaprevir arms who achieve rapid viral response (RVR), defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who stay undetectable at week 12 will receive 24 weeks of treatment. Patients in these treatment arms who do not meet the RVR criteria but are undetectable at week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.
Concurrent 48-Week Second Study to Support Registration
Vertex has agreed to conduct a second well-controlled clinical study as part of the registration program for a treatment-naive indication. The objective of this second study would be to develop additional sustained viral response (SVR) and relapse rate data with 48-weeks treatment duration that confirm results from the Phase 2 studies, thereby providing additional evidence supporting the 24-week regimen in the Phase 3 trial. The design of this second study is being finalized, but at this time Vertex expects this study to enroll approximately 400-500 patients, including patients in the control arm.
The primary objective of the two studies will be to assess the proportion of patients in each study arm who achieve SVR, defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the completion of dosing. Vertex expects to have SVR data from both studies by mid-2010.
(once again, to read the complete article follow the link I provided at the top-Willy)
http://biz.yahoo.com/bw/080123/20080123005338.html?.v=1
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Protease Inhibitor
Wednesday January 23, 7:00 am ET
-- Primary Phase 3 trial will focus on studying 24-week telaprevir-based regimens
-- Vertex plans concurrent second study to support registration
-- Final data from both trials anticipated in mid- 2010
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it will begin Phase 3 evaluation of telaprevir, Vertex’s lead investigational hepatitis C protease inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial that will evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naïve genotype 1 HCV patients. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks. A second study of approximately 400-500 HCV patients is planned to evaluate a 48-week telaprevir-based regimen, to confirm the results from Phase 2 studies and provide additional evidence that supports the 24-week regimen that is being evaluated in the primary Phase 3 trial. The Company expects that both studies will run concurrently and that the first trial will begin enrolling patients in March 2008.
“Data presented in late 2007 from two large Phase 2b studies suggest that telaprevir, dosed in combination with pegylated interferon and ribavirin, may be able to meaningfully increase the proportion of treatment-naïve genotype 1 HCV patients who achieve a sustained viral response, and also cut the current treatment duration in half, to 24 weeks,” said John McHutchison, M.D., Principal Investigator for the primary telaprevir Phase 3 pivotal study and Associate Director of Duke Clinical Research Institute. “Telaprevir is the most advanced protease inhibitor in development for hepatitis C, and the initiation of Phase 3 clinical development for this investigational drug will begin the process of helping to further assess its potential efficacy and the safety in a larger number of patients.”
Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens
In accordance with the design and protocol Vertex submitted to the FDA, the primary pivotal trial will focus on evaluation of 24 weeks of telaprevir-based therapy and will enroll approximately 1050 treatment-naïve, genotype 1 HCV patients, who will be randomized equally across three treatment arms (approximately 350 patients per arm).
The study will be conducted at approximately 100 centers in the U.S., E.U. and certain other countries. The study arms will include:
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone;
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks, then continuing for another 16 weeks with peg-IFN and RBV alone; and
A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.
Patients in both telaprevir arms who achieve rapid viral response (RVR), defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who stay undetectable at week 12 will receive 24 weeks of treatment. Patients in these treatment arms who do not meet the RVR criteria but are undetectable at week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.
Concurrent 48-Week Second Study to Support Registration
Vertex has agreed to conduct a second well-controlled clinical study as part of the registration program for a treatment-naive indication. The objective of this second study would be to develop additional sustained viral response (SVR) and relapse rate data with 48-weeks treatment duration that confirm results from the Phase 2 studies, thereby providing additional evidence supporting the 24-week regimen in the Phase 3 trial. The design of this second study is being finalized, but at this time Vertex expects this study to enroll approximately 400-500 patients, including patients in the control arm.
The primary objective of the two studies will be to assess the proportion of patients in each study arm who achieve SVR, defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the completion of dosing. Vertex expects to have SVR data from both studies by mid-2010.
(once again, to read the complete article follow the link I provided at the top-Willy)
UPDATE 2-Vertex hepatitis C trial timing disappoints
Wed Jan 23, 2008 2:45pm EST
.By Bill Berkrot
NEW YORK, Jan 23 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O: Quote, Profile, Research) said on Wednesday it will begin pivotal late-stage trials of its closely watched hepatitis C treatment, but data to be used to seek its approval will not be available until mid-2010, sending shares to their lowest level in more than two years.
Investors sent the stock down 14 percent, disappointed with a timeline that would not put the drug, telaprevir, on the market before 2011, and with a requirement by U.S. health regulators for a 48-week study in addition to anticipated 24-week trials.
Meanwhile, shares of Human Genome Sciences Inc (HGSI.O: Quote, Profile, Research) plunged 45 percent to a multiyear low on safety concerns involving its experimental hepatitis C treatment Albuferon.
An independent safety monitoring board told the company to modify its late stage trials to eliminate the highest 1,200 microgram dose after finding a higher number of serious adverse lung problems in that patient group.
The trials were continuing with those patients to receive a lower 900 microgram dose, but investors were clearly spooked by the safety signal and analysts said the possibility of once-a-month dosing -- a potential major selling point for Albuferon -- could be in jeopardy.
Vertex (VRTX.O: Quote, Profile, Research) shares have steadily declined since early September as news of potential competition for telaprevir emerged and as the start of the pivotal phase 3 testing program was pushed back later than prior expectations. They are now trading for less than half their value on Sept. 6.
"The bottom line is they had set high expectations for 24-week studies, so the 48-week timeline is obviously a disappointment for some investors," Rodman & Renshaw analyst Navdeep Jaikaria said. Continued...
Wed Jan 23, 2008 2:45pm EST
.By Bill Berkrot
NEW YORK, Jan 23 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O: Quote, Profile, Research) said on Wednesday it will begin pivotal late-stage trials of its closely watched hepatitis C treatment, but data to be used to seek its approval will not be available until mid-2010, sending shares to their lowest level in more than two years.
Investors sent the stock down 14 percent, disappointed with a timeline that would not put the drug, telaprevir, on the market before 2011, and with a requirement by U.S. health regulators for a 48-week study in addition to anticipated 24-week trials.
Meanwhile, shares of Human Genome Sciences Inc (HGSI.O: Quote, Profile, Research) plunged 45 percent to a multiyear low on safety concerns involving its experimental hepatitis C treatment Albuferon.
An independent safety monitoring board told the company to modify its late stage trials to eliminate the highest 1,200 microgram dose after finding a higher number of serious adverse lung problems in that patient group.
The trials were continuing with those patients to receive a lower 900 microgram dose, but investors were clearly spooked by the safety signal and analysts said the possibility of once-a-month dosing -- a potential major selling point for Albuferon -- could be in jeopardy.
Vertex (VRTX.O: Quote, Profile, Research) shares have steadily declined since early September as news of potential competition for telaprevir emerged and as the start of the pivotal phase 3 testing program was pushed back later than prior expectations. They are now trading for less than half their value on Sept. 6.
"The bottom line is they had set high expectations for 24-week studies, so the 48-week timeline is obviously a disappointment for some investors," Rodman & Renshaw analyst Navdeep Jaikaria said. Continued...
"This pushes the timeline to approvals, and as that happens headline risks from competitors changes the competitive landscape, and others can catch up," added Jaikaria, who has a "hold" rating on Vertex stock.
Still, there has been much anticipation among doctors and patients based on earlier trial results that telaprevir, when added to standard treatments of interferon and ribavirin, will be able to halve the current treatment duration to 24 weeks with significantly higher cure rates.
"People appear to be spooked about the need for this other study and are worried that it might turn out to be a 12-month drug," said Sanford Bernstein analyst Geoffrey Porges, who called such fears unfounded.
Interferon is a notoriously difficult drug for patients to tolerate, so telaprevir's potential to halve treatment duration has been a prime source of excitement over the drug.
Vertex said it will begin enrolling the phase 3 trials in March, beginning with two 24-week studies involving 1,050 patients, which will be the primary focus of the program.
In those trials, patients will receive the Vertex drug in combination with pegylated interferon and ribavirin for 12 weeks followed by 12 weeks on the standard drugs alone.
After discussions with the Food and Drug Administration, Vertex also agreed to conduct a study of about 400 to 500 patients to evaluate a 48-week telaprevir-based regimen.
Shares of Cambridge, Massachusetts-based Vertex were down 11.8 percent to $19.74 in afternoon trading on Nasdaq after falling as low as $19.13 earlier in the day.
Human Genome shares were down $4.50, or 44.9 percent, to $5.52, also on Nasdaq. (Additional reporting by Varsha Tickoo in Bangalore; Editing by Jeffrey Benkoe/Tim Dobby
Still, there has been much anticipation among doctors and patients based on earlier trial results that telaprevir, when added to standard treatments of interferon and ribavirin, will be able to halve the current treatment duration to 24 weeks with significantly higher cure rates.
"People appear to be spooked about the need for this other study and are worried that it might turn out to be a 12-month drug," said Sanford Bernstein analyst Geoffrey Porges, who called such fears unfounded.
Interferon is a notoriously difficult drug for patients to tolerate, so telaprevir's potential to halve treatment duration has been a prime source of excitement over the drug.
Vertex said it will begin enrolling the phase 3 trials in March, beginning with two 24-week studies involving 1,050 patients, which will be the primary focus of the program.
In those trials, patients will receive the Vertex drug in combination with pegylated interferon and ribavirin for 12 weeks followed by 12 weeks on the standard drugs alone.
After discussions with the Food and Drug Administration, Vertex also agreed to conduct a study of about 400 to 500 patients to evaluate a 48-week telaprevir-based regimen.
Shares of Cambridge, Massachusetts-based Vertex were down 11.8 percent to $19.74 in afternoon trading on Nasdaq after falling as low as $19.13 earlier in the day.
Human Genome shares were down $4.50, or 44.9 percent, to $5.52, also on Nasdaq. (Additional reporting by Varsha Tickoo in Bangalore; Editing by Jeffrey Benkoe/Tim Dobby
One point in the reference to Albuferon. I think that the trial, and the expected go-forward dosing, is expected as biweekly not monthly as the article indicates.
I'm waiting to see this appear on clinicaltrials.gov so we can get the study locations.
Lots of people down under are hoping we are included.
Lots of people down under are hoping we are included.
What is a non-responder to do?
Nothing here until mid-2010 or later being stated.
I really hate I went into both early treatments in '97 and again in '03. Now being proactive back then keeps me locked out of the Phase 3.
DARN IT!
Nothing here until mid-2010 or later being stated.
I really hate I went into both early treatments in '97 and again in '03. Now being proactive back then keeps me locked out of the Phase 3.
DARN IT!
Vertex is planning Phase 3 trials for non-responders later this year, according to the news articles. I'm sure it's dependent on data from PROVE3 but from all accounts on here, telaprevir shows a lot of promise even for those who have failed previous treatments. We just have to wait a little bit longer. Don't despair.
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