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Medical Forum / Diseases and Disorders / Hepatitis / May 2006Let the trials begin
Vertex to launch human clinical trial for hep C treatment Vertex Pharmaceuticals Inc. has launched a broad midstage human clinical trial to test a promising hepatitis C treatment and will begin a dual effort in June. The Cambridge, Mass., company (Nasdaq: VRTX) said it will conduct the studies in the United States and Europe and enroll 580 patients infected with the hepatitis C virus, which causes a liver disease that can lead to cirrhosis or death. Vertex hopes to use the Phase II studies on the treatment to evaluate safety and effectiveness of the oral treatment on a large scale. By the end of the year, nearly 1,000 people will be involved in clinical trials with VX-950. The company will launch additional studies enrolling up to 400 additional patients. The trials complement at least one earlier smaller Phase II study for which positive results were announced on May 21. Vertex has moved aggressively to forward development efforts for VX-950 since promising early-stage human clinical trial results materialized last year, and has hired dozens of new people to support accelerated development. Current hepatitis C therapies, according to Vertex, only help about 50 percent of infected patients. Ron I dont see anything on clinicaltrial.gov about a trial recruiting yet. look at vertex web site all the info there. Ron > look at vertex web site all the info there. > > Ron Checked out the Vertex site and listened to part of the podcast of the last conference call. However, I dont see any informaton on their site about recruitment centers for the new trials. Provide a link to the page if it exists. Thank you. 1. Vertex is starting a Prove I trial study in the United States with first dosing of patients to occur this June. The study group will be broken down as follows. A. 12 weeks with Vertex in combo with Peg and Riba B. 24 weeks with Vertex in comobo with Peg and Riba C. 12 weeks with Vertex in combo with Peg and riba followed by 36 weeks of just Peg and riba (48 week total) D. Control arm with Peg and Riba (no Vertex) for 48 weeks 2. In the second half of the year, Vertex plans to initiate a Phase IIb study in patients who failed prior standard of care treatment. Again, the link for the entire release is here: http://www.vpharm.com/Pressreleases2006/pr052306.html Ron >1. Vertex is starting a Prove I trial study in the United States with >first dosing of patients to occur this June. [quoted text clipped - 14 lines] > > Ron Ok, that's twice now. Anonymous is asking you if there are any links that lead to RECRUITMENT contacts. Perhaps you could address his question on your third go-around? Cheers /greyhackles You might just call their clinical trial phone number. 1-617-444-6777 Ron > You might just call their clinical trial phone number. 1-617-444-6777 > > Ron I received the following e-mail this morning from Vertex. Thank you for your recent email inquiring about the clinical trials for Vertex's VX-950 compound, being developed for the treatment of chronic Hepatitis C. A Phase 1b study is in progress in Europe, and a Phase 2 study will be initiated in the US by the end of 2006; however, these are small studies that will recruit subjects from their own clinics. The larger Phase 2 multi-center study will start in the United States in early 2006. The location of clinical sites is being finalized now. This study will include patients who are "treatment-naïve", meaning that they have not had prior treatment for hepatitis C. We expect to conduct additional studies in patients who have not responded to prior therapy, but have not yet initiated these studies. The Vertex web site (www.vrtx.com) is the best source of current information on the status of the next study. As the start of the next study nears, the web site will include instructions about how to get contact information for a participating clinical center. You can also call us, starting at 617-444-6777; we expect to have the site information in June of 2006. We appreciate your interest in Vertex and in VX-950, and the time you have taken to write to us and to provide your information. You can also follow the Vertex website (www.vrtx.com) which will have the most up-to-date news about the status of all of our investigational compounds and clinical studies. We wish you well with your medical care. Thank you again for your interest and your continued support of Vertex. Best regards, Clinical Development Staff Vertex Pharmaceuticals Incorporated |
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