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Biocryst receives US FDA approval for human test of influenza drug

BirminghamMonday, December 26, 2005, 08:00 Hrs  [IST]

BioCryst Pharmaceuticals has received from the US Food and Drug Administration a verbal approval to begin studies with intravenous peramivir, the company's influenza neuraminidase inhibitor. In preclinical studies, peramivir has shown potent, broad-spectrum activity against multiple strains of flu, including the H5N1 virus, claims a company release. "This communication from the FDA allows us to move forward with our clinical development of injectable formulations of peramivi. Our clinical plan includes initial development of the intravenous formulation of peramivir, for treatment of acutely ill influenza-infected patients. In addition, we are conducting preclinical studies with intramuscular formulations, which will be directed at patients with earlier stages of influenza infections. We are pursuing both of these development programs in close collaboration with research groups at the National Institutes of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). Phase I clinical testing of the intravenous formulation is expected to begin early in the first quarter of 2006, at the NIH Clinical Centre," said Charles E. Bugg, chairman and CEO of BioCryst. BioCryst Pharmaceuticals, Inc. designs, optimises and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases, and viral infections.

 
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