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Published on 11/16/2005 in the Prospect News Biotech Daily.

Research shows Procyon's protease inhibitor PPL-100 shows potential to treat resistant HIV

By E. Janene Geiss

Philadelphia, Nov. 16 - Procyon Biopharma Inc. announced Tuesday that results of a one-year in vitro resistance selection study of its lead HVI protease inhibitor PPL-100 showed a potentially high genetic barrier, confirming the potential utility of the drug for resistant HIV.

The emergence of multi-resistant HIV viruses continues to challenge clinicians treating HIV despite the last decade of success in treatment due to Highly Active AntiRetroviral Treatment (HAART) - the cocktail of Reverse Transcriptase Inhibitors and Protease Inhibitors, officials said in a news release.

The resistance to protease inhibitors is mainly due to the appearance of mutations in the virus, particularly in the protease gene, due to prolonged use in HIV-positive patients. That's why new antiviral drugs need to be developed, officials said.

Procyon's PPL-100, when subjected to in vitro resistance selection using another protease inhibitor, amprenavir from Glaxo SmithKline, showed that after 52 weeks of evaluation, only four mutations in the protease gene occurred, officials said.

The study also showed that the mutations did not induce any cross-resistance to currently marketed protease inhibitors. Instead, the study showed the T801 mutation potentially causes hypersensitivity of HIV to two other protease inhibitors, officials said.

"We have now a high degree of confidence that when used in the clinical setting, PPL-100 will potentially have a high genetic barrier and hence give a lower chance for resistant HIV strains to arise," Hans J. Mader, president and chief executive officer of Procyon, said in the statement.

He said the company plans to file for the first-in-man phase 1 study this month and expects results within the next four to five months.

Montreal, Quebec-based Procyon is a biotechnology company focused on developing therapeutics for HIV/AIDS and cancer.


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