Viral Genetics focusing on development of VGV-1 in U.S.

By Jennifer Lanning Drey

Portland, Ore., Nov. 8 - Viral Genetics, Inc. will focus its immediate action plans on the U.S. development of its lead product candidate, VGV-1 for treatment of AIDS, according to Michael Capizzano, Viral Genetics' vice president of finance, business and corporate development.

The company's goals for 2007 include completing the supplemental studies necessary to update its pre-Investigational New Drug application to a full Investigational New Drug application in the United States, Capizzano said at the Rodman & Renshaw 8th Annual Healthcare Conference in New York on Wednesday.

Viral Genetics has confirmed that VGV-1, a suspension of thymus nuclear protein, has an anti-viral effect in AIDS. However, the company needs to perform dose-optimization studies and additional work to characterize the molecule as required by the Food and Drug Administration.

The company hopes to begin clinical trials in the United States in the fourth quarter of 2007, Capizzano said. Data from the initial trials would be available 12 to 18 months later.

Viral Genetics has completed a 137-patient phase 3 clinical trial of VGV-1 in South Africa and plans to file a New Drug Application with regulatory authorities in that country after confirming the drug's mechanism of action, Capizzano said.

Viral Genetics is an Azusa, Calif.-based biotechnology company.

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