GeoVax Labs Granted Allowance By FDA to Start Phase 1 Clinical Trial For HIV/AIDS Therapeutic Vaccine
- Category: Vaccines
- Published on Tuesday, 30 March 2010 03:00
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Company Will Begin Non-Blinded Study in HIV Infected Individuals Who Started Drug Treatment During Their First Year of Infection
SMYRNA, GA, USA | March 30, 2010 | GeoVax Labs, Inc. (OTC Bulletin Board:GOVX.ob - News), 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.
SOURCE: GeoVax Labs, Inc.