Antigen working with FDA to fast-track flu vaccine

WORCESTER -- Antigen Express Inc. hopes to begin early-stage clinical trials as early as this fall on a synthetic peptide vaccine that could be made simply, quickly and in large quantities to help prepare for a possible avian flu pandemic. The Worcester firm met last month with the U.S. Food and Drug Administration and said the federal agency gave it clear instructions for moving ahead in the approval process for its vaccine -- a road map that could have Antigen Express filing an Investigational New Drug application with the FDA within a matter of weeks. "The FDA was uncharacteristically outgoing," said Eric von Hofe, president of the eight-person firm, a wholly owned subsidiary of Toronto-based Generex Biotechnology Corp. (Nasdaq: GNBT). "They made it clear what they wanted to see from us." The United States has seen flu vaccine shortages in recent years, and there is widespread concern that should an avian flu pandemic hit it could take years to produce enough vaccine through traditional means, which involve growing the drugs in eggs or cell cultures. "We could produce it on a 100-kilogram scale at any one of a number of contract manufacturers we work with. It's conceivable we could produce enough to vaccinate the majority of the U.S. population," said von Hofe. Concern about an avian flu pandemic continues to mount. Last year, Congress set aside $3.8 billion to aid in preparedness, and several agencies have taken steps to speed production of new treatments, tests and vaccines. According to the Centers for Disease Control, human cases of the avian flu have now been confirmed in 37 countries, with 175 people infected and 96 dead. At least one other firm, San Diego-based Vical Inc. (Nasdaq: VICL), is working to develop an alternative avian flu vaccine-production method using bacteria to produce its DNA vaccine. In early March, the FDA issued guidelines clarifying the data it wants from vaccine makers. Acting FDA Commissioner Dr. Andrew von Eschenbach said that move "illustrates FDA's high level of commitment and key role in preparing for influenza pandemic, which is a top priority for our nation." The FDA created an accelerated approval pathway for the vaccine Fluarix, used to prevent type A and B influenza, in 2005. A new lab test that reduces the time it takes to confirm avian flu from days to hours was also approved on an expedited schedule, with the FDA using what von Eschenbach called "flexible regulatory authorities." Von Hofe hopes his firm's applications will benefit from that flexibility and from regulators' desire to have more vaccines in the pipeline. Antigen Express intends to finish pre-clinical toxicity tests by late summer and is designing Phase I trials. "Source":[ http://boston.bizjournals.com/boston/stories/2006/03/27/story7.html?i=33125].

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