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Valeant Pharmaceuticals to Present Viramidine End-of-Treatment Data From Phase 2 Clinical Trial
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Press release from Valeant. Friday October 1, 8:30 am ET
COSTA MESA, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX - News) announced that an abstract based on Viramidine(TM) 48-week end-of-treatment study data will be posted to the American Association for the Study of the Liver Conference (AASLD) Web site. Valeant submitted the abstract for presentation at AASLD based on data from a Phase 2 clinical trial of Viramidine, a nucleoside (guanosine) analog Valeant is developing in oral form for the treatment of chronic hepatitis C (HCV) in conjunction with a pegylated interferon. Valeant will present the data at AASLD in Boston in October 2004.
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The Viramidine Phase 2 study consists of 180 treatment-naive subjects with chronic HCV. The on-going study is an open-label, randomized, active control trial, being conducted at multiple centers in the United States and with patients stratified by genotype. The study consists of four demographically comparable treatment groups: Viramidine 400 mg BID (800 mg daily), Viramidine 600 mg BID (1200 mg daily), Viramidine 800 mg BID (1600 mg daily) and ribavirin 1000/1200 mg daily all in combination with peginterferon alfa-2a Pegasys). Treatment duration was based on genotype, with genotypes two and three receiving 24 weeks of treatment and genotype one receiving 48 weeks of treatment, each with a post-treatment follow-up period of 24 weeks. The 24-week follow-up period is considered the medically therapeutic standard evaluation of efficacy.
The end-of-treatment analysis was conducted to determine the incidence of anemia (hemoglobin<10g/dL) and also assessed HCV RNA levels (Bayer TMA assay; sensitivity to 5 IU/mL, 25 copies/mL).
At end of treatment, fewer patients developed anemia in the Viramidine arms than in the ribavirin arm (4 percent versus 27 percent; p<0.001). Among patients receiving the 400 mg BID dosage of Viramidine, there were no cases of defined anemia and among patients receiving the 600 mg BID dosage there was only one case of defined anemia (2 percent). In contrast, there was an 11 percent incidence of defined anemia in the 800 mg BID arm and a 27 percent incidence in the ribavirin arm. Other types of adverse events were similar between treatment arms. (The most common adverse events associated with combination therapy are fatigue, headache, insomnia, depression and myalgia.) Differences noted in efficacy were not statistically significant between the Viramidine arms versus ribavirin (Viramidine 400 mg BID - 55 percent, 600 mg BID - 63 percent, 800 mg BID - 56 percent, versus ribavirin - 62 percent; p=NS), all in combination with pegylated interferon alfa-2a, in the proportion of patients with undetectable HCV RNA levels.
Two Phase 3 clinical trials of Viramidine 600mg BID, known as VISER1 and VISER2 (VIramidine's Safety and Efficacy vs. Ribavirin), are being conducted with approximately 100 sites and approximately 1,000 patients in each study. VISER1 compares Viramidine to ribavirin, in combination with Schering-Plough's Peg-Intron®, and completed enrollment in July. VISER2 compares Viramidine to ribavirin, in combination with Roche's Pegasys, and is currently enrolling patients. Phase 3 is the last phase in a multi-phase clinical evaluation that may lead to the filing of a New Drug Application.
About Valeant
Valeant Pharmaceuticals International (NYSE: VRX - News) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at www.valeant.com.
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