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DewDiligence

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Re: genisi post# 65449

Tuesday, 08/19/2008 4:46:11 PM

Tuesday, August 19, 2008 4:46:11 PM

Post# of 253383
Below is VRTX’s PR on the REALIZE study for archival purposes. The most interesting wrinkle is that VRTX borrowed a page from SGP and added a trial arm with a 4-week lead-in of peg-ifn + ribavirin without Telaprevir. (SGP used such a lead-in arm in the phase-2 study of Boceprevir that produced excellent results in the treatment-naïve setting: #msg-31190433.)

It’s notable is that there is no discussion—or even a hint—in this PR that VRTX could file for FDA approval of Telaprevir in the second-line setting based on results from the ‘107’ study for which interim data were reported in April (#msg-28749322). This suggests to me that the FDA may view those highly-touted data with some skepticism.

As was the case with the ‘107’ trial, the REALIZE study includes a mix of null responders, partial responders, and relapsers. This PR does not so say explicitly, but I presume that the trial arms will be stratified for the mix of patients among these three subgroups.

In both Telaprevir arms, the total treatment duration is 48 weeks as opposed to the 24-week duration used by VRTX in the treatment-naïve setting. One Telaprevir arm is “12+36” while the other is “4+12+32.”

http://biz.yahoo.com/bw/080819/20080819005609.html

›Vertex Pharmaceuticals to Start Phase 3 'REALIZE' Trial with Telaprevir in Treatment-Failure HCV Patients

Tuesday August 19, 7:30 am ET

• First HCV protease inhibitor in pivotal trial for this difficult to treat patient population
• Trial to enroll all major treatment-failure patient groups, including null responders, partial responders and relapsers
• Two telaprevir registration programs to address significant unmet need in treatment-naive and treatment-failure patients

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX ) today announced that the Company has reached agreement with U.S. and E.U. regulatory authorities to proceed with the REALIZE trial, a pivotal Phase 3 clinical trial with the hepatitis C virus (HCV) protease inhibitor telaprevir in combination therapy for patients with chronic HCV infection who failed to achieve a sustained viral response (SVR) with prior therapy. The trial will be conducted in the U.S. and E.U. and will enroll approximately 650 genotype 1 HCV patients who failed prior treatment with pegylated-interferon (peg-IFN) and ribavirin (RBV). The trial is designed to evaluate two 48-week telaprevir-based regimens in comparison with a 48-week control arm. Telaprevir will be dosed for 12 weeks. The primary endpoint of the trial is SVR, defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. [This is the standard efficacy endpoint used in all phase-3 HCV trials.]

"In Phase 2 clinical trials, telaprevir-based regimens have demonstrated the potential to increase sustained viral response rates across a broad spectrum of patients infected with the hepatitis C virus, including patients who failed to achieve SVR with previous pegylated interferon and ribavirin therapy, many of whom are at high risk for life-threatening HCV-related complications," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Medical College of Cornell University. "The REALIZE trial of telaprevir is a landmark Phase 3 trial of an investigational HCV protease inhibitor in null responder and other patients who failed prior treatment and will seek to generate additional data to demonstrate the benefit of telaprevir in this difficult to treat patient population."

"Approximately 6 million patients are chronically infected with hepatitis C in the U.S. and E.U. today, and approximately 650,000 of these patients have failed previous treatments of pegylated interferon and ribavirin therapy and are in need of a new therapeutic option to treat their disease," said Kurt C. Graves, Vertex’s Executive Vice President, Chief Commercial Officer and Head, Strategic Development. "Data generated from this Phase 3 trial in treatment-failure patients, as well as data from the ongoing Phase 3 ADVANCE trial in treatment-naïve patients, may further contribute to the emerging profile of telaprevir to address the significant medical need in both treatment-naïve and treatment-failure patients."

Global Phase 3 Trial in Patients who Failed to Achieve SVR with Prior Therapy

The REALIZE Trial (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes) will enroll approximately 650 genotype 1 HCV patients and will be conducted by Tibotec at more than 100 centers in the U.S. and E.U. Tibotec expects to complete enrollment of the REALIZE trial in the first quarter of 2009. The trial will include the following patient groups:

- Null responders (defined as patients who achieved less than 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 failed to achieve undetectable HCV RNA by Week 24 of 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 REALIZE trial will dose telaprevir in combination with pegylated interferon alfa-2a (PEGASYS) and ribavirin. The REALIZE trial will enroll three 48-week trial arms:

1. 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. Delayed start arm [the “lead-in” idea premiered by SGP], comprised of 4 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; and

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.

Updates on the status of Vertex and Tibotec’s clinical trials of telaprevir are available at www.clinicaltrials.gov.

Pivotal Trial in Treatment-Naïve Patients

Vertex and Tibotec are also conducting the global 3-arm pivotal Phase 3 ADVANCE trial in treatment-naïve genotype 1 HCV patients that is focused on 24-week telaprevir-based regimens for patients achieving rapid viral response (HCV RNA <10 IU/mL at 4 weeks). Vertex is on track to complete enrollment of the ADVANCE trial during the fourth quarter of 2008 and expects to have sustained viral response (SVR) data from the trial in the first half of 2010.‹


“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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