>>COSTA MESA, Calif.--(BUSINESS WIRE)--Jan. 20, 2005-- Valeant Pharmaceuticals International (NYSE:VRX - News) today provided an update on its Viramidine® clinical trials and announced that the company completed enrollment in its VISER2 Phase 3 pivotal trial for Viramidine in January 2005. The company is developing Viramidine, a nucleoside (guanosine) analog, in oral form, for administration in combination with pegylated interferon for the treatment of chronic hepatitis C in treatment-naive patients. Valeant has conducted an initial analysis of the sustained viral response (SVR) data for its Viramidine Phase 2 proof-of-concept study compared to ribavirin. The results validate the study design by continuing to show that Viramidine demonstrates comparable efficacy to ribavirin in SVR and a significantly reduced incidence of anemia.
The final analyses of all Phase 2 data have been submitted for presentation to the European Association for the Study of the Liver Conference in April 2005. The Phase 2 trial has met its design objective by confirming the selection of the 600 mg BID dose used in the two pivotal Phase 3 trials: VISER1 and VISER2 (VISER stands for VIramidine's Safety and Efficacy vs. Ribavirin). These two trials compare the 600 mg BID dose of Viramidine to the ribavirin 1,000/1,200 mg daily dose with approximately 100 sites worldwide and approximately 1,000 patients in each study. Phase 3 is the last phase in a multi-phase clinical evaluation that may lead to the filing of a New Drug Application. The significantly expanded patient populations in the Phase 3 studies are necessary to substantiate the reduction in anemia and comparable efficacy seen in the Phase 2 trials.
Timothy C. Tyson, Valeant's President and Chief Executive Officer, said, "We are pleased that the Phase 2 study continues to demonstrate that the 600 mg BID dose chosen for the Phase 3 trials is the appropriate dosing choice. The significantly lower incidence of anemia and comparable efficacy to ribavirin are consistent with the Phase 2 study's previously reported 24 and 48 week interim analyses. We are excited about Viramidine's potential and look forward to continuing the Phase 3 pivotal trials, which both finished enrollment in record time."
The Viramidine Phase 2 study, conducted entirely in the U.S., consisted of 180 treatment-naive subjects with chronic HCV. Treatment duration was based on genotype, with genotypes 2 and 3 receiving 24 weeks of treatment and genotype 1 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 standard evaluation of efficacy.
Anemia rates (Hb less than 10g/dL) during the treatment period were significantly lower in patients treated with Viramidine than those treated with ribavirin (4 percent versus 27 percent; p less than 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 other adverse events associated with combination therapy are fatigue, headache, insomnia, depression and myalgia.)
At the end of the 24-week follow-up period, differences in SVR were not statistically significant among the Viramidine arms and ribavirin. The overall viral response rates, along with the 95 percent confidence intervals (CI) by treatment arm are summarized as follows:
Viramidine Phase 2: Overall Efficacy
Percent of Patients with Undetectable HCV RNA(a)
(Intent-to-Treat Analysis)
End-of-Treatment 24-Week Follow-Up
------------- --- ------------------- -------------------
95% Response 95% 95% Response 95%
Dose N Low Rate High Low Rate High
CI CI CI CI
------------ ------------- --- ---- -------- ----- ---- -------- -----
400mg BID 47 41% 55% 70% 11% 23% 36%
------------- --- ---- -------- ----- ---- -------- -----
Viramidine 600mg BID 43 48% 63% 77% 23% 37% 52%
------------- --- ---- -------- ----- ---- -------- -----
800mg BID 45 37% 51% 66% 16% 29% 42%
------------ ------------- --- ---- -------- ----- ---- -------- -----
ribavirin 1,000/1,200mg
Daily 45 48% 62% 76% 30% 44% 59%
------------ ------------- --- ---- -------- ----- ---- -------- -----
(a)Bayer TMA Assay; sensitivity to 5 IU/mL, 25 copies/mL
Kim D. Lamon, M.D., Ph.D., Valeant's President, R&D, and Chief Scientific Officer, noted, "The patient population in the Phase 2 study provided sufficient data to clearly point to the 600 mg BID dose as the appropriate dose to use in the Phase 3 studies designed to further substantiate the reduction in anemia and the comparable efficacy to ribavirin."
Robert Gish, M.D., Medical Director of the Liver Transplant Program at the California Pacific Medical Center in San Francisco, California, and the principal investigator in the Phase 2 trial, said, "The reduced incidence of anemia seen with Viramidine 600 mg BID is a potentially significant advance in the treatment of HCV. Ribavirin-associated anemia (Hb less than 10g/dL) occurs in approximately 20-30 percent of patients and often requires dose reduction or discontinuation of the ribavirin, or the administration of erythropoietin. An agent that reduces the incidence of anemia and does not compromise efficacy would be a great therapeutic alternative to the current standard of care."
Additional information regarding the Phase 2 trial was filed by the company today with the Securities and Exchange Commission on Form 8-K and is also available on the company's Web site at www.valeant.com. <<
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