Full Press Release Details
404.727.0971 or rmcnally@geovax.com
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MONDAY, SEPTEMBER 21, 2009
GEOVAX LABS REQUESTS PRE-IND MEETING WITH FDA
Protocol Submitted for Phase 1 Therapeutic HIV/AIDS Vaccine Trial
ATLANTA September 21, 2009 GeoVax Labs, Inc. (OTC BB: 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
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 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. The
proposed human trial follows the precedents set in the preclinical animal trials and is a critical step towards
developing a therapeutic vaccine for HIV-1 infected humans.
Submission of a request to the FDA for a pre-IND meeting is the first step in a process that is expected to take a
number of months to complete. Commencement of the trial is targeted for the first quarter of 2010.
About GeoVax Labs, Inc.
GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human
vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax s AIDS
vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use
in uninfected people to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should
the person become infected. GeoVax AIDS vaccines also may be effective as a therapeutic treatment (for people already
infected with the HIV-1 virus).
GeoVax s core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and
Development, through a collaboration of colleagues at Emory University s Vaccine Center, the National Institutes of
Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.
GeoVax s AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN)
based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health
(NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines.
Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided
additional support to GeoVax AIDS vaccine development program with a $17 million IPCAVD grant awarded in late 2007.
Safe Harbor Statement
All statements in this news release, not statements of historical fact, are forward-looking statements. These
statements are based on expectations and assumptions on the date of this press release and are subject to numerous
risks and uncertainties which could cause actual results to differ materially from those described in the
forward-looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and
manufacture these vaccines with the desired characteristics in a timely manner, GeoVax s vaccines will be safe for
human use, GeoVax s vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals
necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is
development of competitive products that may be more effective or easier to use than GeoVax s products, and other
factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and
does not intend to do so. Certain matters discussed in this news release are forward-looking statements involving
certain risks and uncertainties including, without limitation, risks detailed in the Company s Securities and Exchange
Commission filings and reports.