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Second Phase 3 Study for Viramidine Initiated
The second study, known as VISER2 (VIramidine's Safety and Efficacy vs. Ribavirin), began patient enrollment recently, following the company's clinical investigator meetings in the U.S. and Europe. Valeant expects to complete enrollment in VISER2 in 2005. Valeant's first global Phase 3 trial of Viramidine, known as VISER1, began in late 2003 and is continuing patient enrollment. Valeant expects to complete enrollment in VISER1 in 2004.
Each of the Phase 3 studies will be conducted at approximately 100 sites with approximately 1,000 patients in each study. The studies will compare Viramidine and ribavirin, each in conjunction with a pegylated interferon.
Valeant has also submitted an abstract of the 48-week data from the Phase 2 study for presentation at the 55th Annual Meeting of the American Association for the Study of Liver Diseases in Boston in October and November 2004.
Source: Valeant Pharmaceuticals