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GeoVax Labs, Inc.announced their HIV/AIDS vaccine is one of the select few to move forward into Phase 2a human trials by the HIV Vaccine Trials Network
ATLANTA, GA, USA | February 25, 2008 | GeoVax Labs, Inc. (OTC BB: GOVX), www.geovax.com, an Atlanta based biotechnology company, announced their HIV/AIDS vaccine is one of the select few to move forward into Phase 2a human trials by the HIV Vaccine Trials Network (HVTN), a network supported by the National Institutes of Health (NIH).
GeoVax’s AIDS vaccine is believed to be only the fifth [5th] HIV/AIDS vaccine to be selected to move forward into Phase 2a human trials conducted by the HVTN. In contrast, it was approximately HVTN’s 65th vaccine evaluated in Phase 1 human trials.
Most recently, GeoVax Senior Vice President of Research & Development, Dr. Harriet Robinson, and President, Don Hildebrand, attended a meeting with key HTVN officials in Seattle, Washington to plan and prepare necessary documents for the next phase of testing of GeoVax’s promising HIV/AIDS vaccine, namely Phase 2a human trials designated as Protocol # HVTN 205.
Attended by over 20 HVTN personnel and key GeoVax personnel, this event included individuals instrumental in organizing and implementing human clinical trials designed to evaluate the GeoVax HIV/AIDS vaccine. The newly planned Phase 2 trials are tentatively scheduled to start mid-2008 and will involve up to 500 participants at several locations in the USA.
“We are delighted that our HIV/AIDS vaccine has been selected to move forward into Phase 2 trials. Our vaccine continues to demonstrate the promise of not only being safe but also effective at eliciting potentially protective immune responses,” stated Dr Harriet Robinson, Senior Vice President Research & Development at GeoVax.
“GeoVax is extremely pleased to have passed the significant hurdles required to move into Phase 2 trials. Only a handful of AIDS vaccines have reached the Phase 2 level of clinical evaluation with the HVTN, including the previously failed vaccines of Vaxgen and Merck,” stated GeoVax President, Don Hildebrand.
GeoVax has completed two Phase 1 human trials evaluating its AIDS vaccines with excellent results and has three additional human trials currently underway. Due to promising results from these five trials the HVTN is pushing forward with plans for critically important and larger Phase 2 human trials.
GeoVax AIDS vaccine technology and composition are significantly different than the Merck & Co. Inc. AIDS vaccines that recently had their human trials halted due to safety and effectiveness concerns.
About GeoVax Labs, Inc.
GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's AIDS vaccine technology is covered by 20 issued or filed patent applications. GeoVax HIV/AIDS vaccines are designed to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1 and may be effective as therapeutics (treatment of people already infected with AIDS virus). Studies evaluating these vaccines in HIV/AIDS infected individuals are in the planning stage.
GeoVax’s core HIV/AIDS vaccine technologies were developed through a collaboration of colleagues at Emory University’s Vaccine Center, the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and the GeoVax team.
GeoVax HIV/AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN] based in Seattle, Washington. The HVTN, funded and supported by the National Institutes of Health [NIH), is the largest worldwide clinical trials program dedicated to the development and testing of HIV/AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by the National Institute of Allergy and Infectious Diseases (NIAID). The NIH provided additional support to GeoVax AIDS vaccine development program with a $15 million IPCAVD grant awarded in late 2007
GeoVax DNA & MVA Genetically Engineered HIV/AIDS vaccines:
DNA vaccine “primes” immune responses & MVA vaccine “boosts” immune responses against the AIDS virus
-- Are both genetically engineered vaccines expressing over 50% of the AIDS virus components in vaccine recipients and can not cause AIDS
-- Protected 22 of 23 (96%) non-human primates against AIDS for over 3½ years
-- Are manufactured & tested under GMP/GLP – EMEA (EU) and FDA [USA] guidelines
-- Satisfactorily completed 2 earlier HIV/AIDS vaccine Phase 1 human trials
-- Currently have 3 ongoing Phase 1 Human Trials – 1 was initiated in 2006, 2 in summer 2007
-- Have been demonstrated safe to date in human trials
-- Demonstrate positive anti-HIV immune responses in majority of human vaccine recipients
-- Are planned for mid 2008 Phase 2 trials based on success in previous HVTN conducted trials
SOURCE: GEOVAX
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