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GeoVax Labs Requests pre-IND Meeting With FDA
Date:9/21/2009

ATLANTA, Sept. 21 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that it has requested a pre-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 HIV/AIDS.

HIV affects the entire globe and comes in a variety of subtypes. Clade B is the predominant subtype in North America, where there are roughly 60,000 new infections each year. Globally, there are about 2.5 million AIDS infections per year, most primarily involving subtypes AG, B, and C. In 2007, UNAIDS reported 1.3 million people living with AIDS in North America and 33.2 million people living with AIDS worldwide.

"This pre-IND meeting with the FDA is a significant step toward meeting the needs of those individuals currently infected with HIV/AIDS. The FDA has 60 days from our submission to review our proposal and respond with questions or comments," stated Robert McNally, Ph.D., president and chief executive officer. "The need for a HIV/AIDS vaccine is clear, based on the continued increase of new infections in the United States, despite years of education and preventative measures. Current costs for oral medications and the numerous side effects of these drugs give further urgency to the need for a therapeutic vaccine," noted Dr. McNally.

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 Phase 1 therapeutic protocol stresses safety parameters to minimize any risk to the volunteers. The protocol, conceived with collaboration from ARCA (AIDS Research Consortium of Atlant
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