, May 27
/PRNewswire-FirstCall/ -- GeoVax Labs, Inc.
(OTC Bulletin Board: 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 firstname.lastname@example.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 (Human Immunodeficiency Virus - that leads to AIDS) and other infectious agents. Our goals include developing HIV/AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting clinical 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 vaccines have demonstrated the 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. Recently the FDA granted permission to proceed with a Phase 1 therapeutic trial for individuals infected with HIV. 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 Investor Relations Group:
James Carbonara / Jason Strominger
Janet Vasquez / Robin O'Malley
SOURCE GeoVax Labs, Inc.