Data presented by BioChem Pharma Inc. last week at the NinthInternational Conference on AIDS in Berlin indicate that theCanadian company's anti-viral compound 3TC is safe, well-tolerated and not toxic in HIV-infected patients who aresymptomatic -- from ARC (AIDS-related complex) to full-blownAIDS.
Moreover, during the course of the 52-week Phase I/II trial,the drug, which is a nucleoside analog, exhibited anti-viralactivity as measured by surrogate markers, including counts ofCD4 cells, the most commonly used indicator of degree of viralinfection.
The analysis presented in Berlin confirms and extends the dataon the North American trial that BioChem Pharma presented inMay at the Third Annual Canadian Congress on HIV/AIDSResearch in Montreal. The dose-ranging trial studied patientswho received from 0.5 to 20 mg/kg/day of 3TC, with 10-18patients at each dose level.
"At doses of 8 mg/kg/day and above, we saw an initial rise inCD4 counts and then sustained levels over 52 weeks," said JohnGillard, BioChem Pharma's vice president of therapeuticsresearch and development.
BioChem Pharma also presented data in Berlin from itsEuropean Phase I/II clinical trial, in which the HIV-positivepatients were either asymptomatic or "mildly ARC," and froman ongoing Phase I/II of 3TC in children with HIV infection.According to the company, those data showed similar results.
The company has also found that 3TC can act synergisticallywith AZT to inhibit HIV-1 replication in vitro. In fact, thecompany is now initiating double-blind Phase II/III surrogatemarker trials in the U.S., Canada and Europe comparing 3TCalone and in combination with AZT to AZT, or to AZT plus theanti-viral ddC in early and advanced HIV infection.
Glaxo Group Ltd. is managing the development of 3TC as part ofa collaborative agreement with BioChem Pharma(NASDAQ:BCHXF) of Laval, Quebec, that also coverscommercialization of the drug. -- Jennifer Van Brunt0614933TC
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