Some may not have read this so I thought I would post it. Some interesting stuff. From the europe trials it looked like the arm without riba didn't do as well but maybe good enough. Also it looks like they will begin phase 3 later this year. So in reality this could be at Market as early as late 2008 or early 2009.
Vertex Pharmaceuticals Reports 2007 Pipeline Progress
— More than 1000 patients have now been enrolled in Phase 2b PROVE trials —
— More than 350 patients have completed 12 weeks of telaprevir dosing in PROVE trials —
— Interim results from PROVE 2 consistent with findings from PROVE 1—
Cambridge, MA, June 12, 2007--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today detailed recent progress in its clinical pipeline in conjunction with its participation at the Goldman Sachs 28th Annual Healthcare Conference. A live webcast of Vertex’s presentation will be available on Vertex’s website, www.vrtx.com, beginning at 2:00 p.m. PDT (5:00 p.m. EDT) on June 13, 2007.
“In the first half of 2007, we have made significant progress in advancing our business and in the development of our pipeline,” said Joshua Boger, Ph.D., Vertex’s President and Chief Executive Officer. “Specifically, we have enrolled more than 1,000 patients in the PROVE studies evaluating telaprevir, our investigational hepatitis C protease inhibitor, and more than 350 patients have now completed 12 weeks of telaprevir-based dosing. Today, we announced the completion of enrollment in PROVE 3. We are now focused on discussions with regulatory agencies in the U.S. and Europe to enable transitioning to the start of Phase 3 development of telaprevir planned for the fourth quarter of this year.”
Mid-2007 Pipeline Update
Broad clinical development program for telaprevir (VX-950)
The PROVE clinical program, consisting of three major Phase 2b trials, is designed to evaluate: 1) the optimal SVR (sustained viral response) rate that can be achieved with telaprevir-based therapy; 2) the optimal treatment duration for telaprevir; 3) the safety profile of telaprevir; and 4) the role of ribavirin in telaprevir-based therapy. In its program for treatment-naïve patients, Vertex is focused on evaluating regimens of 24 weeks total duration, with the inclusion of ribavirin in the treatment combination.
The PROVE 1 clinical trial is continuing on track in the U.S. PROVE 1 is a randomized, placebo-controlled trial that enrolled 250 treatment-naïve genotype 1 patients with hepatitis C. Vertex anticipates completing a planned interim analysis in July 2007 for patients in the 24-week treatment arm of this trial. The interim analysis will focus on 12-week post-treatment antiviral results, and Vertex expects that these data will be presented at a medical meeting later in 2007.
The PROVE 2 clinical trial is also continuing on track in Europe. PROVE 2 is a randomized, placebo-controlled trial that enrolled approximately 240 genotype 1 treatment-naïve HCV patients on telaprevir-based regimens and 80 patients who were randomized to receive pegylated interferon alfa 2a (peg-IFN) and ribavirin (RBV). Vertex recently received preliminary data from the first planned interim analysis of PROVE 2, and expects that these data will be presented at a medical meeting later in 2007. At this time, Vertex is reporting that the preliminary results are consistent with findings reported for PROVE 1. Patients in the treatment arms that included telaprevir, peg-IFN and RBV had rates of undetectable HCV RNA (<10 IU/mL) at 4 and 12 weeks similar to those observed in PROVE 1. The adverse events observed in the PROVE 2 trial, and the rate of treatment discontinuations for 240 patients through 12 weeks of telaprevir-based dosing, appear consistent with the PROVE 1 results reported by Vertex in April. At 12 weeks, the treatment arm in PROVE 2 that did not include ribavirin was associated with antiviral activity that was lower compared to treatment arms that included ribavirin, telaprevir, and peg-IFN, but still substantially higher than that observed in the control arm. As reported for PROVE 1, rash, gastrointestinal events and anemia were the most common events leading to discontinuation in the telaprevir arms. Fewer discontinuations due to adverse events were observed in patients receiving telaprevir and peg-IFN without RBV.
Vertex today announced that it has completed patient enrollment in the PROVE 3 clinical trial with more than 440 patients. PROVE 3 is a Phase 2b clinical trial of telaprevir in patients with genotype-1 HCV who have not achieved SVR with a previous interferon-based treatment.
With the completion of enrollment in PROVE 3, there are more than 1,000 patients enrolled in the PROVE clinical program for telaprevir and, to date, more than 350 patients who have completed 12 weeks of telaprevir-based dosing.
Vertex and Tibotec, with whom Vertex is collaborating to develop and commercialize telaprevir in Europe and other countries, are using available data on telaprevir to design a comprehensive Phase 3 clinical trial program for telaprevir. Pending additional data from the PROVE program, and the outcome of discussions with regulatory agencies, the start of an international Phase 3 clinical trial for telaprevir in genotype 1 treatment-naïve patients is planned for the fourth quarter of 2007.
In May, Vertex successfully completed drug substance registration batches of telaprevir. The Company has also started the manufacturing validation process for telaprevir drug substance and expects to complete the validation by the end of the year. Vertex continues to make a significant investment to prepare for the commercial supply and marketing of telaprevir, subject to its continued progress.