Biotech Values

[DewDiligence]

JNJ Starts Phase-3 Telaprevir Study in Second-Line HCV

[The trial is called REALIZE and the general design was disclosed by VRTX two months ago (#msg-31572666); what’s new in this PR is additional detail on the patient pool and trial arms. The breakdown of the 650 total patients is 350 patients (54% of total) who relapsed in the first-line setting and 300 patients (46% of total) who were null or partial first-line responders. The Telaprevir-to-control randomization ratio is 2:1 to allow for two Telaprevir arms: one arm with a 4-week lead-in period of Peg-IFN + ribavirin without Telaprevir (“4+12+32”) and one arm without a lead-in period (“12+36”).

Of note: the August PR announcing the design of this trial (#msg-31572666) said enrollment was expected to be complete in 1Q09; however, the PR below makes no such assertion.]

http://www.pipelinereview.com/content/view/22639/109/

›Mechelen, Belgium | October 15, 2008 | Tibotec BVBA announced today that it has begun enrolling patients in its phase III clinical trial evaluating telaprevir, an investigational hepatitis C virus protease inhibitor, in patients who failed prior therapy with peginterferon (Peg-IFN) plus ribavirin (RBV). The trial, known as REALIZE, will compare the efficacy, safety and tolerability of telaprevir combined with Peg-IFN plus RBV versus Peg-IFN and RBV alone, the current standard of care. Investigators at U.S. trial centers have begun screening patients for participation in the study, with global centers expected to begin screening in the coming weeks. Telaprevir is being co-developed by Vertex Pharmaceuticals Incorporated and Tibotec. Tibotec, the sponsor of the REALIZE trial, is managing the trial worldwide.

"We are excited about the ongoing development of telaprevir, potentially the first direct antiviral for the treatment of HCV, which may provide a new option for patients who have failed the current standard of care," said Roger Pomerantz, MD, President, Tibotec Research and Development. "We are committed to examining the safety and efficacy of telaprevir through phase III trials and look forward to working with health authorities with the goal of making this therapy available to HCV infected patients."

The REALIZE trial (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes) is a phase III, randomized, placebo-controlled double-blind study conducted over 72 weeks to examine two regimens of 750 mg telaprevir every eight hours (with and without a delayed start) combined with Peg-IFN and RBV versus Peg-IFN and RBV alone. To be eligible for the study, patients must belong to one of the following three groups:

• Null responders (defined as patients who achieved <2 log reduction in HCV RNA at week 12 of prior therapy);

• Partial responders (defined as patients who achieved at least a 2 log reduction at week 12, but never achieved undetectable HCV RNA during prior therapy); and

• Relapsers (defined as patients who had undetectable HCV RNA at the completion of at least 42 weeks of prior treatment, but relapsed during follow-up).

The trial will enroll approximately 650 HCV patients at more than 30 centers in the U.S., 50 centers in Europe and 20 centers in the rest of the world. The study will include 300 null- and partial-responder patients and 350 patients with viral relapse. REALIZE is the first phase III study to evaluate a direct antiviral (or STAT-C) treatment for HCV in null responder patients.

The primary endpoint of the REALIZE study is sustained virologic response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. Patients enrolled in this study will be randomized to three treatment arms:

1. [“12+36”]: Telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of Peg-IFN and RBV, followed by 36 weeks of treatment with Peg-IFN and RBV alone;

2. [“4+12+32”]: Delayed start arm, comprised of four weeks of treatment with Peg-IFN and RBV, followed by telaprevir dosed at 750 mg q8h for 12 weeks in combination with standard doses of Peg-IFN and RBV, followed by another 32 weeks of Peg-IFN and RBV alone; or

3. A control arm with standard doses of Peg-IFN and RBV dosed for 48 weeks.

Patients in all treatment arms will be followed for 24 weeks after completion of treatment to assess SVR.
For additional information on inclusion and exclusion criteria for this study, please see www.clinicaltrials.gov.
The REALIZE phase III study in treatment failure patients is part of a comprehensive clinical development program for telaprevir. Vertex is managing the ADVANCE phase III trial in treatment-naive patients.

Tibotec has the right to develop and commercialize telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand. Vertex will commercialize telaprevir in the U.S., Canada and Mexico.

As a global virology leader committed to patient care, Tibotec uses innovative science and expertise to research, develop, manufacture and market drugs of unmet need. Tibotec is dedicated to building a portfolio of novel antiviral therapies to address the significant unmet needs of patients with chronic hepatitis C. In addition to its partnership with Vertex to develop and commercialize telaprevir, Tibotec is currently developing with partner Medivir a second potential treatment for HCV which is in early stage trials. Through the application of its deep understanding of virology and viral resistance, Tibotec has become an established leader in HIV/AIDS, having developed and made available two antiretroviral agents for the treatment of HIV. Tibotec continues its commitment to developing novel therapies through a robust research and development program, which includes a third anti-HIV treatment as well as a potential treatment for tuberculosis.

About Tibotec BVBA

Tibotec BVBA is a global pharmaceutical and research development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, Pa. and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need. Tibotec is a member of the Johnson & Johnson family of companies.‹



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