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HCV Protease Vertex/Tibotec Telaprevir Update
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Excerpts from Vertex press announement
"Vertex and Tibotec are evaluating other dosing regimens for telaprevir, as well as the potential role of telaprevir in important HCV sub-populations.
-- Vertex and Tibotec today provided an update on study C208, based on an interim analysis conducted at 12 weeks. C208 is a four-arm Phase 2a clinical study of approximately 160 genotype 1 treatment-naive HCV patients. A main objective of the C208 study is to explore the safety and antiviral activity of a twice-daily dosing regimen of telaprevir (1125mg every 12 hours) in combination with peg-IFN and RBV, as compared to a three times daily regimen (750mg every 8 hours). In the interim analysis, the type and frequency of adverse events across the study arms were generally consistent with previous studies of telaprevir. No substantial differences in safety profile between twice daily and three times daily dosing regimens were observed. The interim analysis showed that both twice-daily and three times daily dosing arms of telaprevir, with pegylated interferon alfa-2a (Pegasys) and ribavirin, had greater than 80% of patients (intent-to-treat analysis) with undetectable HCV RNA (<10 IU/mL) at weeks 4 and 12. These data support continued clinical evaluation of twice-daily dosing of telaprevir. A complete analysis will be performed upon the conclusion of this study in 2009. Vertex expects that interim data will be presented at a medical conference later in 2008......
-- Next-generation HCV protease inhibitor in clinical development
-- Vertex is advancing a portfolio of HCV protease inhibitors with potentially differentiated profiles. VX-500 has completed a Phase 1a clinical trial, and the Company expects to initiate a Phase 1b clinical trial with VX-500 in patients with HCV in the third quarter of 2008. The Company also expects to initiate Phase 1 development of VX-813 in the third quarter of 2008."
Vertex Pharmaceuticals Highlights Telaprevir Progress and Reports Second Quarter 2008 Results
-- Treatment-failure data and treatment-naive data strengthen
telaprevir's potential profile and highlight broad opportunity
in treatment of chronic hepatitis C virus (HCV) infection
-- VX-770, for cystic fibrosis (CF), completes enrollment for
28-day Phase 2a study; 2009 targeted for initiation of
registration studies, pending 28-day study results
CAMBRIDGE, Mass., Jul 31, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported recent clinical progress and consolidated financial results for the quarter ended June 30, 2008.
"Chronic hepatitis C is a major global unmet medical need with many patients at an increased risk for cirrhosis, liver failure, liver cancer and early death," said Joshua Boger, Ph.D., President and Chief Executive Officer of Vertex Pharmaceuticals. "With our commitment to addressing this broad need, we are working to establish a profile for telaprevir that has the potential to shorten treatment duration and increase sustained viral response rates for treatment-naive patients, and also the potential to provide a new treatment option for patients who failed to achieve sustained viral response with a prior course of pegylated interferon and ribavirin therapy."
"We continue to build a pipeline of clinical candidates beyond telaprevir. Our pipeline provides further opportunity for growth by extending our HCV category leadership and by broadening our pipeline of clinical candidates into other disease areas," continued Dr. Boger. "In HCV we have advanced the development of our second-generation HCV protease inhibitors, VX-500 and VX-813. In cystic fibrosis, we are also rapidly advancing VX-770, our lead drug candidate, and have fully enrolled a study that will evaluate 28-day dosing in patients with CF, with potential to move quickly to a registration program for this drug candidate."
Telaprevir Development Program
Phase 3 Development in Treatment-Naive Population
-- Vertex and Tibotec are enrolling patients in the global 3-arm pivotal Phase 3 ADVANCE trial that is focused on 24-week telaprevir-based regimens that utilize rapid viral response (RVR) criteria. Vertex expects to complete enrollment of this study during the fourth quarter of 2008 and expects to have sustained viral response (SVR) data from the study in the first half of 2010.
-- Vertex expects to begin in the third quarter of 2008 a 450-patient study in treatment-naive patients that will include evaluation of 24-week and 48-week telaprevir-based regimens. The Company expects to complete enrollment in this study by the end of 2008, and expects to have SVR data from the study in the first half of 2010.
Phase 3 Development in Patients Who Failed to Achieve SVR with Prior Treatment
-- Vertex and Tibotec are initiating in Europe Phase 3 clinical development of telaprevir in patients who failed to achieve SVR with prior treatment of pegylated interferon (peg-IFN) and ribavirin (RBV). This study is focused on 48-week telaprevir-based regimens and is expected to enroll approximately 650 patients. The companies are engaged in discussions with the U.S. FDA to transition to Phase 3 clinical development of telaprevir in patients who failed to achieve SVR with prior treatment of peg-IFN and RBV and plan to begin patient screening in the U.S. in the third quarter of 2008.
Telaprevir Clinical Data
Treatment-Naive Patient Population
-- In April, clinical investigators presented data from the PROVE 1 and PROVE 2 clinical trials in treatment-naive patients at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in Milan. Final results from the PROVE 1 clinical trial and an interim analysis from the PROVE 2 clinical trial showed consistently higher SVR rates and antiviral response in the 24-week telaprevir arms - 61% of patients in PROVE 1 and 68% of patients in PROVE 2 achieving SVR, compared with 41% of patients in the PROVE 1 control arm achieving SVR and 48% of patients in the PROVE 2 control arm having undetectable HCV RNA at 12 weeks post-treatment.
Patients Who Failed to Achieve SVR with Prior Peg-IFN and RBV Treatment
-- In June, Vertex reported results of an interim analysis from PROVE 3, an ongoing Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who did not achieve SVR with a previous pegylated interferon-based treatment. In the interim analysis, 52% of patients randomized to receive treatment with a 24-week telaprevir-based regimen (12 weeks of telaprevir-based treatment followed by an additional 12 weeks of peg-IFN and RBV treatment) maintained undetectable HCV RNA (less than 10 IU/mL) 12 weeks post-treatment. In the control arm, at week 36 of a planned 48-week treatment duration, 30% of patients had undetectable HCV RNA.
-- In April, in a late-breaker poster presentation at EASL, clinical investigators reported data from an interim analysis of Study 107, an open-label clinical trial that is enrolling patients with genotype 1 HCV who did not achieve SVR with previous interferon-based treatment in the control arms of PROVE 1, PROVE 2 or PROVE 3. In the interim analysis, patients treated with a telaprevir-based treatment regimen demonstrated a high rate of viral response, and a low rate of viral breakthrough at week 4. This response appears to have been maintained, with no viral breakthrough observed to date among 36 patients who had completed 4 weeks of treatment, and among 16 of those patients who had completed 12 weeks of treatment.
Telaprevir Safety and Tolerability: Phase 2b PROVE Program
-- In Phase 2 clinical studies to date, more than 700 patients with genotype 1 HCV have received a telaprevir-containing combination regimen, and the adverse event profile is generally consistent across studies and prior analyses. In studies, telaprevir is being evaluated in combination with peg-IFN and RBV for the treatment of patients chronically infected with HCV genotype 1. In telaprevir studies, the most common adverse events reported more frequently in patients receiving telaprevir were gastrointestinal events, skin events (rash, pruritus) and anemia. There have been reports of severe rashes in clinical studies of telaprevir-based therapy. Other adverse events reported were similar in type and frequency to those seen currently with peg-IFN and RBV treatment. In clinical studies, the most common reason for discontinuation among patients receiving a telaprevir-based treatment regimen was rash (7% of patients).
Additional Telaprevir Clinical Trials
Vertex and Tibotec are evaluating other dosing regimens for telaprevir, as well as the potential role of telaprevir in important HCV sub-populations.
-- Vertex and Tibotec today provided an update on study C208, based on an interim analysis conducted at 12 weeks. C208 is a four-arm Phase 2a clinical study of approximately 160 genotype 1 treatment-naive HCV patients. A main objective of the C208 study is to explore the safety and antiviral activity of a twice-daily dosing regimen of telaprevir (1125mg every 12 hours) in combination with peg-IFN and RBV, as compared to a three times daily regimen (750mg every 8 hours). In the interim analysis, the type and frequency of adverse events across the study arms were generally consistent with previous studies of telaprevir. No substantial differences in safety profile between twice daily and three times daily dosing regimens were observed. The interim analysis showed that both twice-daily and three times daily dosing arms of telaprevir, with pegylated interferon alfa-2a (Pegasys) and ribavirin, had greater than 80% of patients (intent-to-treat analysis) with undetectable HCV RNA (<10 IU/mL) at weeks 4 and 12. These data support continued clinical evaluation of twice-daily dosing of telaprevir. A complete analysis will be performed upon the conclusion of this study in 2009. Vertex expects that interim data will be presented at a medical conference later in 2008.
-- Vertex and Tibotec announced today that patient enrollment is complete in a Phase 2 study evaluating telaprevir in patients infected with genotype 4 HCV. Vertex and Tibotec also announced that enrollment is complete in a Phase 2 trial in patients infected with genotype 2 or genotype 3 HCV.
-- Next-generation HCV protease inhibitor in clinical development
-- Vertex is advancing a portfolio of HCV protease inhibitors with potentially differentiated profiles. VX-500 has completed a Phase 1a clinical trial, and the Company expects to initiate a Phase 1b clinical trial with VX-500 in patients with HCV in the third quarter of 2008. The Company also expects to initiate Phase 1 development of VX-813 in the third quarter of 2008.
Updates on the status of telaprevir clinical trials are available at www.clinicaltrials.gov.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and cystic fibrosis. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
Conference Call and Webcast: Second Quarter Financial Results:
Vertex Pharmaceuticals will host a conference call and webcast today, Thursday, July 31, 2008 at 5:00 p.m. EDT to review financial results and recent developments. This call and webcast will be broadcast via the Internet at www.vrtx.com. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides. The link to the webcast is available on the Events and Presentations button on the home page.
To listen to the call on the telephone, dial (800) 374-0296 (U.S. and Canada) or (706) 634-2224 (International). Vertex is also providing a podcast MP3 file available for download on the Vertex website at www.vrtx.com.
The call will be available for replay via telephone commencing July 31, 2008 at 8:00 p.m. EDT running through 5:00 p.m. EDT on August 7, 2008. The replay phone number for the U.S. and Canada is (800) 642-1687. The international replay number is (706) 645-9291 and the conference ID number is 56407129. Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. EDT on August 14, 2008.
Vertex's press releases are available at www.vrtx.com.
(VRTX-GEN)
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Michael Partridge, 617-444-6108
Senior Director, Strategic Communications
or
Lora Pike, 617-444-6755
Manager, Investor Relations
or
Zachry Barber, 617-444-6470
Manager, Media Relations
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