GEOVAX LABS GRANTED ALLOWANCE BY FDA TO START PHASE 1 CLINICAL TRIAL FOR HIV/AIDS THERAPEUTIC VACCINE
Company Will Begin Non-Blinded Study in HIV Infected Individuals
Who Started Drug Treatment During Their First Year of Infection
SMYRNA, GA - March 30, 2010 - GeoVax Labs, Inc. (OTCBB: GOVX), a biotechnology company
that creates, develops, and tests innovative HIV/AIDS vaccines, is now allowed by the FDA (US Food
and Drug Administration) to begin a phase 1 clinical trial for GeoVax's therapeutic vaccine, which is
intended as a treatment for individuals infected with HIV (Human Immunodeficiency Virus). The
company will begin a non-blinded study in HIV infected individuals who started drug treatment during
their first year of infection.
Robert McNally, Ph.D., President and CEO of GeoVax, stated, "Based upon preclinical animal data, we
believe our therapeutic vaccine may improve treatment options for people infected with HIV and are
delighted we will be able to begin a phase 1 clinical trial. An unmet need exists in the market for a HIV
therapeutic vaccine if it can reduce the need for expensive and poorly tolerated lifelong oral medications
currently available to infected individuals. We also recognize that this trial will enable GeoVax to
gather crucial information toward our vaccine's success on a more timely basis than the time required to
perform a preventative trial. "
The protocol for the Phase 1 clinical trial, conceived in collaboration with ARCA (AIDS Research
Consortium of Atlanta), will carefully monitor safety while evaluating the ability of the vaccine to elicit
protective immune responses in vaccinated participants. The next step of starting the process will be a
submission by ARCA to the IRB (Institutional Review Board) for local review of trial documentation, a
standard requirement to protect human subjects. The trial is based on the achievement of 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.
About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV-1 (Human
Immunodeficiency Virus - AIDS) and other infectious agents. Our goals include developing AIDS
vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions
(FDA guidelines), conducting human trials for vaccine safety and effectiveness, and obtaining
regulatory approvals to move the product forward. All preventative phase 1 human clinical trials
conducted to date tested various combinations and doses of our DNA and MVA AIDS vaccines in
human volunteers for their demonstrated ability to raise anti-HIV immune responses as well as for their
safety. Successful results from all phase 1 testing supported the initiation of the first phase 2 testing.
GeoVax's phase 2 human trial began in January 2009 and will involve 225 participants at sites in the
United States and South America. Long term, we expect that GeoVax will grant manufacturing and
distribution rights in several global markets in return for upfront fees, collaborative development
agreements, and royalties on sales and distribution revenues. Internal vaccine manufacturing and
distribution will also be considered by GeoVax. For more information, please visit www.geovax.com.
Certain statements in this document are "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act. These statements are based on management's current expectations and are
subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in
these statements due to a variety of factors, including 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, GeoVax
will be able to enter into favorable manufacturing and distribution agreements, 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. More information about these factors is contained in GeoVax's filings with the Securities and
Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
At the Company:
Robert McNally, President & CEO
(678) 384-7220 or firstname.lastname@example.org
At The Investor Relations Group:
James Carbonara / Jason Strominger
Janet Vasquez / Robin O’Malley
"Reproduced with permission - GeoVax Labs, Inc."
GeoVax Labs, Inc.