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 phase 1, 2 and 3 human trials for vaccine safety and effectiveness, and obtaining regulatory approval of these vaccines in the USA and specified international markets.
Outstanding preclinical results: GeoVax DNA/MVA vaccine protected 96% of non-human primates for over 3˝ yrs. To our knowledge, this level of protection has not been achieved by other candidate vaccines.
In 2005, a phase 1 human clinical trial tested GeoVax's DNA vaccine. This trial concluded successfully, demonstrating the safety of our DNA vaccine(details).
After receiving ”Safe to Proceed” status for a new Investigational New Drug (IND) by the U.S. Food and Drug Administration (FDA), a phase 1 trial combining low doses of the DNA vaccine with the MVA vaccine began in May 2006. An additional phase 1 trial began in September 2006 to test full doses of the vaccines. In total, this phase 1 testing included four trials. All tested various combinations and doses of our DNA and MVA AIDS vaccines in human volunteers for their ability to raise Anti-AIDS immune responses as well as for their safety.
Successful results from all phase 1 testing of GeoVax's vaccines supported the initiation of the first phase 2 testing of our product. GeoVax's phase 2 human trial began in January 2009 and involves 225 participants at sites in the United States and South America.
Long term, we expect that GeoVax will enter into agreements to out-license manufacturing technology to major vaccine production companies and distribution rights to key companies in several global markets in return for upfront fees, collaborative development agreements, and royalties on sales and distribution revenues. Internal vaccine manufacture and sale will be considered by GeoVax.