U.S. Government Continues Support for Clinical Development of Adjuvanted Vaccine
ATLANTA, Aug. 16, 2011 /PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based, biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, today announced receipt of a $3.6 million annual notice of award for the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Grant supporting GeoVax's HIV/AIDS vaccine program.
This grant was originally awarded in 2007 to GeoVax by the National Institutes of Health-National Institute of Allergy & Infectious Disease (NIH-NIAID), an agency of the U.S. Government. Only meritorious HIV/AIDS prevention vaccine candidates are considered to receive an IPCAVD award.
This most recent annual award represents the fifth year's award, bringing the aggregate award to date to $19.6 million. GeoVax will utilize this funding to further production of its GM-CSF adjuvanted vaccine for planned human clinical trials.
"This award will allow us to maintain momentum on the successful development of our GM-CSF adjuvanted vaccine," said Harriet Robinson, Ph.D., Chief Scientific Officer of GeoVax and Program Director for the Award. "Depending on FDA submission schedules, we anticipate beginning a Phase 1 clinical trial within the next six months. The exciting thing about using the GM-CSF adjuvant is that it significantly increases prevention of infection. Without the adjuvant, our vaccine has been demonstrated to successfully control infection, but prevention of infection is the ultimate goal. There is widespread enthusiasm and desire for a vaccine that provides the promise for prevention of infection."
"We just had our annual External Advisory Board Meeting for our GM-CSF adjuvant project," said Robert McNally, Ph.D., President & CEO of GeoVax. "It was very productive with the outside experts being highly enthusiastic about the GM-CSF adjuvanted vaccine and very complimentary of the progress GeoVax has made."
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing of 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. GeoVax's vaccines are unique in expressing virus like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing supported the initiation of the first Phase 2 testing. GeoVax's Phase 2 human trial began in January 2009 and involves 300 participants at sites in the United States and South America. Recently GeoVax began enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV. 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 its 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.
The Investor Relations Group
Erika Moran, Investor Relations
Janet Vasquez, Public Relations
SOURCE GeoVax Labs, Inc.