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Valeant Pharmaceuticals to Present New HBV Drug Remofovir Pharmacokinetic and Pharmacodynamic Data From Phase 1 Clinical Trial
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Press release from Valent. Tuesday October 5, 8:31 am ET
COSTA MESA, Calif., Oct. 5 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX - News) announced that an abstract based on remofovir pharmacokinetic (PK) and pharmacodynamic (PD) study data has been posted to the American Association for the Study of the Liver Conference (AASLD) Web site. Valeant submitted the abstract based on data from a Phase 1 clinical trial of remofovir, which is being developed in oral form for the treatment of chronic hepatitis B (HBV), for presentation at AASLD. Valeant will present the data at AASLD in Boston on November 2, 2004.
The remofovir double-blind, placebo-controlled, parallel group, multiple-dose Phase 1 study consists of 45 adult Asian patients with compensated HBV infection. All patients were 18 years or older and had an HBV DNA viral load greater than or equal to 3,000,000 copies/mL at screening. Eight to ten patients were randomized to each of the remofovir dose groups (5, 10, 20 and 30 mg) or placebo and were dosed for 28 days. Safety assessment included adverse events, physical examination, vital signs and safety laboratory tests. Serum HBV DNA levels were also determined in all patients predosing, and on days one, eight, 15, 21 and 28 of treatment. Following discontinuation of therapy, HBV levels were determined at weeks four, eight and 12 using the COBAS Amplicor assay.
The most frequently reported adverse event among all study patients was upper respiratory infection (30 percent). No dose-related trends regarding safety were identified and no events resulted in a patient being withdrawn prematurely from treatment.
At all doses, serum HBV DNA levels decreased with time. After 28 days of remofovir treatment, the median log(10) HBV decline from baseline was 1.64 at the 5 mg dose, 2.48 at the 10 mg dose, 2.72 at the 20 mg dose and 2.66 at the 30 mg dose. In contrast, the placebo dose group had a median log(10) drop of HBV DNA of 0.03.
A Phase 2 trial of remofovir was initiated in July 2004. The Phase 2 study is an open-label, randomized, multiple dose study that will enroll 220 patients at approximately 20 sites in the U.S., Taiwan, Singapore and Korea. The study consists of five treatment groups: remofovir -- 5, 10, 20 and 30 mg/day, and adefovir dipivoxil -- 10 mg/day. Treatment duration will be 48 weeks, with an interim analysis planned for 24 weeks to evaluate safety and efficacy. Enrollment is ongoing. Phase 2 is one 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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