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VX-950 Phase 2b PROVE 1 Study Interim Safety & Antiviral Activity at Week 12
  "Results of First Interim Safety and Antiviral Analysis of the PROVE 1 Clinical Trial of Investigational HCV Protease Inhibitor Telaprevir (VX-950)"
MECHELEN, Belgium, December 13 /PRNewswire/ -- Tibotec BVBA and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from a planned interim safety analysis from PROVE 1, an ongoing Phase 2b clinical trial of the investigational hepatitis C virus (HCV) protease inhibitor telaprevir (VX-950). Following an agreement earlier this year, Tibotec and Vertex are collaborating to develop telaprevir in Europe, South America, Australia, the Middle East, and selected Asian countries.
Interim Safety and Antiviral Results
In accordance with the PROVE 1 study design, an interim safety and antiviral activity analysis has been conducted, and the data have been reviewed by the independent data monitoring committee overseeing the trial. A total of 250 patients were enrolled and in addition to peg interferon-2a (peg-IFN) + ribavirin (RBV) received at least one dose of telaprevir or placebo in the study. In the data reported, patients in all three telaprevir containing groups were pooled together (n=175) and the results were compared to the results in the control arm of peg-IFN + RBV and placebo (n=75). At the time of the data cut-off for the safety analysis, approximately 100 patients had completed 12 weeks on-study.
The most common adverse events were similar in type between the two groups and were characteristic of the known side effects of interferon and ribavirin. Of these, the adverse events that were more commonly reported in the telaprevir groups included gastrointestinal disorders and rash. In the telaprevir groups, as of the cut-off date, 9% of patients had discontinued treatment due to adverse events, compared to 3% of patients in the control arm. The difference between the two groups is due to the greater number of discontinuations due to rash, gastrointestinal disorders, and anemia in the telaprevir arms compared to the control arm. Three percent (3%) of patients in the telaprevir arms discontinued due to rash, the most common adverse event leading to treatment discontinuation in the study. Serious adverse events were noted in 3% of patients in the telaprevir groups and 1% of patients in the control group.
Of the 74 patients in the telaprevir groups for whom data were available at the end of 12 weeks, 65 (88%) demonstrated undetectable HCV RNA (less than 10 IU/mL; Roche Taqman), compared to 17 of 33 (52%) of patients in the control arm.
These results from the interim analysis of safety and antiviral activity need to be confirmed by the results of the final analysis before conclusions on the safety and efficacy can be made.
"Chronic hepatitis C infection is a major public health problem, and our goal is to increase the success rate of hepatitis C treatment with short-duration therapy," said Roger Pomerantz, M.D., President of Tibotec Research and Development. "This interim analysis of PROVE 1 is an important step forward in the telaprevir clinical development program, as it strongly supports the initiation and conduct of large phase III clinical trials designed to evaluate the safety and antiviral activity of telaprevir."
About the PROVE 1 Study
PROVE 1 is a four-arm, double-blind, placebo-controlled Phase 2b clinical trial of telaprevir (VX-950) in treatment naive patients with genotype 1 HCV infection. The protocol placed no restriction on patient entry into the trial based on weight, race/ethnicity or baseline viral load. In the trial, telaprevir was dosed in combination with pegylated interferon-2a (peg-IFN-2a) and ribavirin (RBV). The primary objective of PROVE 1 is to assess the proportion of patients in each study arm who achieve sustained viral response (SVR), defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan assay) HCV RNA 24 weeks after the completion of dosing. The study was fully enrolled in September 2006 and is ongoing at approximately 35 centers in the U.S. All subjects will have completed telaprevir dosing by the third week of December 2006.
About Telaprevir (VX-950)
Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, that specifically targets HCV. Vertex is conducting a global Phase 2b clinical development program for telaprevir consisting of three large clinical trials that are expected to enroll approximately 1000 patients with HCV at clinical centers in the United States and Europe. The U.S.-based PROVE 1 trial is fully enrolled and ongoing. The PROVE 2 study is underway in Europe and is expected to complete enrollment with approximately 320 patients within the next few weeks. In clinical trials, telaprevir is being dosed as 750 mg every eight hours in combination with pegylated interferon alfa-2a (Pegasys(r)), both with and (in the PROVE 2 study) without ribavirin (Copegus(r)).
Vertex, Janssen Pharmaceutica and Tibotec are collaborating to develop and commericalise telaprevir in Europe, South America, Australia, the Middle East, and other countries. Vertex retains commercial rights to telaprevir in North America. Vertex is collaborating with Mitsubishi Pharma to develop and commercialize telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a liver disease caused by infection with hepatitis C virus (HCV), which is found in the blood of people with the disease. HCV, a serious public health concern affecting 170 million people worldwide, is spread through direct contact with the blood of an infected person. Though many people with hepatitis C may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Hepatitis C significantly increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death.
About Tibotec
Tibotec BVBA, based in Mechelen, Belgium, is a pharmaceutical research and development company. The Company has offices in Cork, Ireland and Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec, a division of Janssen-Cilag, will bring innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa This new division was created within the Janssen-Cilag companies in October 2005 to focus on patients' and health care providers' specific needs in this disease domain. The company will also commercialize medicine against other viral diseases in the future.
For more information, visit www.tibotec.com
Distributed by PR Newswire on behalf of Tibotec BVBA and Vertex Pharmaceuticals Incorporated
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