GeoVax Labs, Inc. Provides Third Quarter 2009 Financial Results and Operatio...(re-Investigational New Drug (IND) meetin...),Health

Date:11/6/2009

re-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss a proposed IND for GeoVax's therapeutic vaccine as a treatment for individuals infected with the HIV virus. A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The protocol for the Phase 1 clinical trial, conceived with collaboration from ARCA (AIDS Research Consortium of Atlanta), has specific objectives to optimize safety while evaluating the ability for the vaccine to elicit protective immune responses in vaccinated participants. The proposed trial is based on the achievement of excellent post vaccine viral control in animal trials conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University. Assuming a positive outcome from the FDA, the Company expects that the Phase 1 therapeutic trial could begin as early as during the first quarter of 2010. In order to facilitate an understanding of the IND process by GeoVax's shareholders, the Company has prepared a graphical representation of the process, which is available on the Company's website at www.geovax.com.

GeoVax's Phase 2a clinical trial for the preventative version of its HIV/AIDS vaccine is ongoing and patient enrollment is proceeding to the Company's satisfaction. This trial, designated as HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN). The HVTN, funded and supported by the National Institutes of Allergy and Infectious Disease (NIAID), is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. When fully enrolled there will be a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients). The trial is being conducted at 13 HVTN trial sites: 11 in North America and two in South America.

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