Aa
Telaprevir trial
Was wondering if anyone has heard about another phase of the Telaprevir trial starting in Sept? I heard something about this trial having a different protocol and possibly no placebo arm. Has anyone heard anything about this? Thanks
I think i found what I was looking for. Seems Vertex is going to have a 2nd study within the phase 3 trial for treatment naive. See the 2nd paragraph below where it says 400-500 people will be in a 48 week telaprevir based regimen study. I believe everyone in this study will get telaprevir which is good but the way I read it is having to do all 48 weeks with no shorter tx. I was looking to hopefully be a RVR and only do 24 weeks so if I'm reading this correctly this trial may not be right for me.
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational
Hepatitis C Protease Inhibitor
-- 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., Jan 23, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) 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-naive 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-naive 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-naive, 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(R) assay) HCV RNA 24 weeks after the
completion of dosing. Vertex expects to have SVR data from both studies by mid-2010.
Update on Meeting with FDA
Vertex and the FDA met in mid-January 2008 to discuss telaprevir's Phase 3 development program. This meeting included a
review of available data from Phase 2b clinical trials of telaprevir, including newly available post-treatment data from the 48-
week treatment arms in PROVE 1. In the control arm of PROVE 1, on an ITT basis, 37% of patients had undetectable HCV RNA
at 12 weeks post-treatment follow-up. In the 48-week ("12+36") telaprevir-based treatment arm in PROVE 1, also on an ITT
basis, 66% of patients had undetectable HCV RNA at 12 weeks post-treatment follow-up. The relapse rate in the 48-week
telaprevir-based arm in PROVE 1 was 6%.
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational
Hepatitis C Protease Inhibitor
-- 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., Jan 23, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) 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-naive 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-naive 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-naive, 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(R) assay) HCV RNA 24 weeks after the
completion of dosing. Vertex expects to have SVR data from both studies by mid-2010.
Update on Meeting with FDA
Vertex and the FDA met in mid-January 2008 to discuss telaprevir's Phase 3 development program. This meeting included a
review of available data from Phase 2b clinical trials of telaprevir, including newly available post-treatment data from the 48-
week treatment arms in PROVE 1. In the control arm of PROVE 1, on an ITT basis, 37% of patients had undetectable HCV RNA
at 12 weeks post-treatment follow-up. In the 48-week ("12+36") telaprevir-based treatment arm in PROVE 1, also on an ITT
basis, 66% of patients had undetectable HCV RNA at 12 weeks post-treatment follow-up. The relapse rate in the 48-week
telaprevir-based arm in PROVE 1 was 6%.
Sorry forgot to post the link.
http://www.clinicaltrials.gov/ct2/show/NCT00703118?term=VERTEX&recr=Open&rank=7
It tells all about the phase 3 trial, last week there was a link to all the locations where it would be in the usa. But now that link is not there.
can
http://www.clinicaltrials.gov/ct2/show/NCT00703118?term=VERTEX&recr=Open&rank=7
It tells all about the phase 3 trial, last week there was a link to all the locations where it would be in the usa. But now that link is not there.
can
This is the latest study on telapervir. I am in the process now on trying to get in it and what cities they are in.
Phase 3 Study in Patients Who Failed Prior Treatment
Vertex and Tibotec plan to initiate a Phase 3 clinical trial in genotype 1 HCV patients who have failed prior treatment with peg-IFN and RBV in the third quarter, which will be led by Tibotec. The randomized, double-blind and placebo-controlled study will focus on regimens of 48 weeks total treatment duration, in which telaprevir is administered for 12 weeks, with a goal of maximizing SVR rates. The study is planned to be conducted at more than 50 centers in the U.S., European Union (E.U.), and certain other countries.
Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are available at www.clinicaltrials.gov.
Phase 3 Study in Patients Who Failed Prior Treatment
Vertex and Tibotec plan to initiate a Phase 3 clinical trial in genotype 1 HCV patients who have failed prior treatment with peg-IFN and RBV in the third quarter, which will be led by Tibotec. The randomized, double-blind and placebo-controlled study will focus on regimens of 48 weeks total treatment duration, in which telaprevir is administered for 12 weeks, with a goal of maximizing SVR rates. The study is planned to be conducted at more than 50 centers in the U.S., European Union (E.U.), and certain other countries.
Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are available at www.clinicaltrials.gov.
There is not much published about VX-813 at this point or for that fact of the matter the VX-500 drug except this little excerpt but I’m sure more will be coming out soon. I am hoping that either drug will have less sx surrounding the rash as experienced by Telapervin.
VX-500 is a second-generation HCV protease inhibitor. Vertex has initiated dosing in a Phase 1a clinical trial of VX-500. The trial will evaluate single, escalating doses of VX-500 in healthy volunteers. Pending results from the Phase 1a trial, Vertex expects to initiate in mid-2008 a Phase 1b trial of VX-500 in HCV patients.
Nothing here that appears to have blockbuster potential as yet…with the potential exception of VX-500, which is their follow-on HCV protease inhibitor drug, currently in pre-human testing. Ideally this would be ready to take over from telaprevir—with better efficacy and milder AEs—around 2013 or so.
http://caps.fool.com/Ticker/VRTX.aspx
VX-500 is a second-generation HCV protease inhibitor. Vertex has initiated dosing in a Phase 1a clinical trial of VX-500. The trial will evaluate single, escalating doses of VX-500 in healthy volunteers. Pending results from the Phase 1a trial, Vertex expects to initiate in mid-2008 a Phase 1b trial of VX-500 in HCV patients.
Nothing here that appears to have blockbuster potential as yet…with the potential exception of VX-500, which is their follow-on HCV protease inhibitor drug, currently in pre-human testing. Ideally this would be ready to take over from telaprevir—with better efficacy and milder AEs—around 2013 or so.
http://caps.fool.com/Ticker/VRTX.aspx
This?
A new Phase III study looking at 24 vs 48 weeks and starting with Peg and Riba before introducing telaprevir to market...
"Vertex announces new trial of telaprevir in non responders
Last updated:26June2008
A speedier-than-expected regulatory filing for Vertex Pharmaceuticals' hepatitis C drug appears less likely after the company disclosed plans on Monday for a new phase III study of the drug.
Investors have been hoping that Vertex and partner Johnson & Johnson could seek regulatory approval for telaprevir in 2009 based on data from existing clinical trials in treatment-resistant patients. However, the companies posted details of a new phase III study of telaprevir in treatment-resistant hepatitis C patients on the ClinicalTrials.gov Web site on Monday. The disclosure dampened investor outlook for a quick telaprevir filing.
If Vertex cannot file telaprevir with the U.S. Food and Drug Administration in 2009, the filing will likely come in the second half of 2010 after studies of the drug in treatment-naïve hepatitis C patients are completed.
"We have learned that telaprevir's phase III study in treatment experienced hepatitis C patients is different from PROVE 3 and study 107, which in our view decreases the chances of an early filing," wrote Citibank analyst Yaron Werber in a note to clients Monday evening. PROVE 3 and study 107 refer to the existing telaprevir studies in treatment-resistant patients.
Werber has a hold rating on Vertex, and perhaps echoing the sentiment of his momentum and catalyst-driven hedge fund clients, he added that, "We are no longer warming up to the stock and believe the momentum has cooled off as we believe that the chances for an early approval on PROVE 3 and 107 are low."
Vertex spokesman Michael Partridge says Monday's disclosure of a new phase III telaprevir study is in line with the company's previous guidance and "not closely connected to a possible [FDA] filing based on PROVE 3 results."
Partridge added that Vertex and the FDA are still discussing the previously disclosed PROVE 3 data, but that "initiation of a new phase III study is a natural extension of the PROVE 3 results which we would have started no matter the path to a filing."
The new phase III study disclosed on Monday will test two different regimens of telaprevir in patients who previously did not respond to conventional hepatitis C treatment with pegylated interferon and ribavirin.
The study differs from previous studies in that patients will be treated with two regimens of telaprevir for a full 48 weeks instead of the accelerated 24-week treatment cycle used for treatment-naïve patients.
In addition, one of the arms of the new study will see whether a "lead-in" treatment with interferon and ribavirin alone before dosing of telaprevir may improve overall cure rates.
The design of the new study is sufficiently different from the previous PROVE 3 and study 107 trials to suggest that regulators want more and different data on telaprevir's effect on treatment-resistant patients before considering the drug for approval.
Cowen & Co. analyst Rachel McMinn views Monday's selloff as an overreaction to expected news. She reiterated her outperform raring on Vertex.
"We believe that yesterday's [Vertex] sell off was driven by an over-reaction to two-week old information. Timelines for commercial launch of telaprevir (late 2010/early 2010) are unchanged, and we see 50% upside relative to the market on the basis of this timeframe. While probability of an early 2009 FDA approval is low, we see 100% upside relative to the market under this scenario over the next 6-12 months."
Ciao.
Hector
A new Phase III study looking at 24 vs 48 weeks and starting with Peg and Riba before introducing telaprevir to market...
"Vertex announces new trial of telaprevir in non responders
Last updated:26June2008
A speedier-than-expected regulatory filing for Vertex Pharmaceuticals' hepatitis C drug appears less likely after the company disclosed plans on Monday for a new phase III study of the drug.
Investors have been hoping that Vertex and partner Johnson & Johnson could seek regulatory approval for telaprevir in 2009 based on data from existing clinical trials in treatment-resistant patients. However, the companies posted details of a new phase III study of telaprevir in treatment-resistant hepatitis C patients on the ClinicalTrials.gov Web site on Monday. The disclosure dampened investor outlook for a quick telaprevir filing.
If Vertex cannot file telaprevir with the U.S. Food and Drug Administration in 2009, the filing will likely come in the second half of 2010 after studies of the drug in treatment-naïve hepatitis C patients are completed.
"We have learned that telaprevir's phase III study in treatment experienced hepatitis C patients is different from PROVE 3 and study 107, which in our view decreases the chances of an early filing," wrote Citibank analyst Yaron Werber in a note to clients Monday evening. PROVE 3 and study 107 refer to the existing telaprevir studies in treatment-resistant patients.
Werber has a hold rating on Vertex, and perhaps echoing the sentiment of his momentum and catalyst-driven hedge fund clients, he added that, "We are no longer warming up to the stock and believe the momentum has cooled off as we believe that the chances for an early approval on PROVE 3 and 107 are low."
Vertex spokesman Michael Partridge says Monday's disclosure of a new phase III telaprevir study is in line with the company's previous guidance and "not closely connected to a possible [FDA] filing based on PROVE 3 results."
Partridge added that Vertex and the FDA are still discussing the previously disclosed PROVE 3 data, but that "initiation of a new phase III study is a natural extension of the PROVE 3 results which we would have started no matter the path to a filing."
The new phase III study disclosed on Monday will test two different regimens of telaprevir in patients who previously did not respond to conventional hepatitis C treatment with pegylated interferon and ribavirin.
The study differs from previous studies in that patients will be treated with two regimens of telaprevir for a full 48 weeks instead of the accelerated 24-week treatment cycle used for treatment-naïve patients.
In addition, one of the arms of the new study will see whether a "lead-in" treatment with interferon and ribavirin alone before dosing of telaprevir may improve overall cure rates.
The design of the new study is sufficiently different from the previous PROVE 3 and study 107 trials to suggest that regulators want more and different data on telaprevir's effect on treatment-resistant patients before considering the drug for approval.
Cowen & Co. analyst Rachel McMinn views Monday's selloff as an overreaction to expected news. She reiterated her outperform raring on Vertex.
"We believe that yesterday's [Vertex] sell off was driven by an over-reaction to two-week old information. Timelines for commercial launch of telaprevir (late 2010/early 2010) are unchanged, and we see 50% upside relative to the market on the basis of this timeframe. While probability of an early 2009 FDA approval is low, we see 100% upside relative to the market under this scenario over the next 6-12 months."
Ciao.
Hector
here is the link to the Vertex website...but it doesn't say anything about the study that you referenced in the other post...but I know I read something...I will search the history on my computer to see if I can find it...may take a while...couple of days.
http://www.vrtx.com/current-projects/drug-candidates/telaprevir-VX-950.html
http://www.vrtx.com/current-projects/drug-candidates/telaprevir-VX-950.html
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