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ARCA Launches First Therapeutic Trial with GeoVax Vaccine
Study to Enroll HIV-Infected Individuals Who Started Drug Treatment
During Their First Year of Infection
Atlanta, Georgia (May 27, 2009)- GeoVax Labs, Inc. (OTCBB: GOVX),a biotechnology
company that creates, develops and tests innovative HIV/AIDS vaccines, announced today The
AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the
first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax,
Inc. Although the GeoVax vaccines are currently being studied for HIV prevention, this is the
first study using the same products for treatment of persons who already have HIV infection.
ARCA is the only site for this trial.
"ARCA is pleased to be conducting this important clinical trial," said Dr. Melanie Thompson,
Principal Investigator for ARCA. "New approaches to HIV treatment are critically needed, and
an effective therapeutic vaccine would be an important tool in our ongoing efforts to treat people
with HIV infection. A vaccine that enhanced the body's ability to control HIV and delayed or
decreased the dependence on anti-HIV drugs would be a major breakthrough for HIV treatment."
To be eligible for the study, persons should have had a negative HIV test followed by a positive
test up to 6 months later, and they should have started drugs to fight HIV within 6 months of
being diagnosed. The study will last up to 77 weeks. All patients will be followed closely for
safety and for the ability of the vaccine to elicit protective immune responses in vaccinated
participants. Patients will be compensated for their participation in the study. Only 10 to 12
persons will be selected to participate. Persons who believe they may qualify for the study
should contact ARCA at vaccine@arcatlanta.org or 404-876-2317. ARCA is also interested in
identifying possible candidates who fit the enrollment criteria but have not yet started anti-HIV
drugs.
ARCA worked together with GeoVax to design the protocol for the Phase 1 clinical trial. The
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.
About the AIDS Research Consortium of Atlanta
ARCA is a registered 501(c)(3) not-for-profit clinical research, testing, outreach and educational
organization founded in 1988. ARCA works through a network of more than 50 physicians and 5
public health clinics to conduct clinical drug and vaccine trials and prevention research studies. 2
ARCA also provides patient and care-provider educational programs, free STD testing for men,
and free, anonymous HIV testing when funds are available. More than 6000 Atlantans have
learned their HIV status through ARCA's HIV testing program. ARCA has become one of the
most respected and successful HIV/AIDS research facilities in the country over the past two
decades by enrolling more than 2,000 metro Atlanta residents in more than 300 clinical drug
trials that provide the latest investigational HIV/AIDS medications at no cost to them. ARCA
has contributed key scientific information leading to the FDA approval of more than 27
individual and combination drugs now available for people with HIV/AIDS worldwide. ARCA
was one of only three centers in the US that participated in a Centers for Disease Control and Prevention
(CDC) study to test the safety of tenofovir, an existing HIV medicine, as a possible tool to
prevent HIV infections. Over a 14 year period, ARCA enrolled more than 10.000 Atlantans with
HIV infection in a CDC study to better understand HIV and AIDS. In all, more than 20,000
Atlantans have participated in ARCA studies and services. For more information, visit
www.arcatlanta.org.
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.
Forward-Looking Statements
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.
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Contact
At the Company:
Robert McNally, President & CEO
(678) 384-7220 or rmcnally@geovax.com
At The Investor Relations Group:
Investor Relations
James Carbonara / Jason Strominger
or
Public Relations
Janet Vasquez / Robin O’Malley
(212) 825-3210
"Reproduced with permission - GeoVax Labs, Inc."
GeoVax Labs, Inc.
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