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GeoVax Labs, Inc. Reports Fourth Quarter and Year End 2009 Financial Results
Date:3/1/2010

Therapeutic Vaccine Trial – IND Submitted to FDA

The protocol for the Phase 1 clinical trial, conceived with collaboration from ARCA (AIDS Research Consortium of Atlanta), will carefully monitor 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 studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.  

GeoVax completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for its therapeutic trial in December 2009.  The clinical path for this non-blinded trial is expected to have a much shorter duration than the program for the development of a preventative vaccine. The Company recently submitted its Investigational New Drug application to the FDA for the therapeutic trial. Following receipt of the IND, the FDA has 30 days to respond. After that time, if there are no concerns from the FDA the Company may begin the trial.


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