Procyon gets OK to begin first-in-man phase 1 study of treatment for drug-resistant HIV

By E. Janene Geiss

Philadelphia, Dec. 8 - Procyon Biopharma Inc. announced Thursday that it has received regulatory approval from the Therapeutic Products Directorate of Health Canada to begin the first-in-man phase 1 clinical trial for its lead protease inhibitor PPL-100 for the treatment of drug-resistant HIV.

The first-in-man phase 1 study, which will be initiated by the end of December, will be an escalating dose, placebo-controlled study conducted with 40 healthy male subjects, 30 receiving the active medication and 10 receiving placebo, according to a company news release.

Five doses of PPL-100 (300, 600, 1200, 1800 and 2400mg) will be administered in order to determine the maximum-tolerated dose.

Results from this study, including safety, tolerability and single-dose pharmacokinetics, will be used to finalize the protocol of the subsequent multi-dose study that is expected to be completed in the second quarter of fiscal 2006, officials said.

The first-in-man phase 1 study is to be conducted in a U.S. Food and Drug Administration-approved contract research organization in Canada.

In November, the company said that data from the in vitro resistance study indicated the high genetic barrier of PPL-100, confirming the potential utility of the drug for first-line treatment of resistant HIV patients.

New antiviral drugs with a high genetic barrier, which make it more difficult for the virus to develop resistance, are needed to fight the emergence of resistant HIV viruses, officials said.

"We are very happy to have met this important milestone in our lead HIV protease inhibitor PPL-100 development program, as this allows us to advance this promising drug candidate to the clinical stage. As well, we expect to have results available within the next 4 to 5 months," Hans J. Mader, Procyon president and chief executive officer, said in the release.

Procyon is a Montreal, Quebec, biotechnology company actively engaged in the discovery and development of innovative therapeutics in the fields of cancer and HIV/AIDS.

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