ATLANTA, May 22 /PRNewswire/ -- GeoVax, Inc. announced today that its HIV/AIDS human clinical trials have begun at several sites around the USA. These trials are made possible as a result of the recently received “Safe to Proceed” status for a new Investigational New Drug (IND) by the U.S. Food and Drug Administration (FDA). The trials include testing of both DNA and MVA components of an HIV/AIDS vaccine developed by a team of researchers at GeoVax, the Yerkes National Primate Research Center at Emory University and the Emory Vaccine Center, along with colleagues at the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).
U.S. sites participating in the HIV Vaccine Trials Network include the University of Alabama at Birmingham, Saint Louis University, the University of Maryland and Vanderbilt University. Trials at these locations are being conducted with HIV-negative volunteers. The HVTN is funded and supported by the National Institute of Allergy and Infectious Disease (NIAID) of the NIH.
The vaccine uses a two-part DNA prime-boost strategy developed by a scientific team led by Harriet Robinson, PhD, Chief of Microbiology and Immunology at Emory University, a member of the Emory Vaccine Center and head of the GeoVax Scientific Advisory Board. The vaccine technology was licensed to GeoVax, a company founded by Dr. Robinson, Don Hildebrand, GeoVax President/CEO, Emory University and the Emory Vaccine Center to further develop, evaluate, test and manufacture it.
The trials have two phases. The first phase will be a dose escalation to evaluate safety and immune responses. Initially, low doses of the two vaccine components will be given to 12 volunteers. If the vaccine proves safe, it will then be tested at a high dose in 36 volunteers. If the vaccine proves safe and shows good immunogenicity in the dose escalation studies, a second phase of clinical testing will be initiated. In this phase, 72 volunteers will be used to conduct the initial studies on optimizing the dosing schedule.
The vaccine includes two inoculations of a DNA vaccine that primes the immune system to recognize HIV and two doses of subsequent booster vaccine based on a recombinant MVA poxvirus. The vaccine produces the three major proteins expressed by HIV and is expected to induce the immune system to respond to these distinguishing features of HIV should the actual virus appear. As a safety consideration, neither component of the vaccine incorporates the complete intact HIV virus. As reported in the journals, Nature Medicine in 2001 and later in Science, a prototype of this vaccine was successful in containing a challenge virus and preventing progression to AIDS in 22 of 23 vaccinated rhesus macaque monkeys.
About GeoVax, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus - AIDS) and other infectious agents. Present 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 approval of these vaccines in the USA and international markets. Global market estimates exceed $4 billion for effective and safe AIDS vaccines.
GeoVax Inc. recently signed an AGREEMENT and PLAN of MERGER with Dauphin Technology, Inc. with GeoVax the proposed surviving company controlling over 60% of newly issued and outstanding stock and receiving additional operating capital.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be determined to be safe for use in humans, GeoVax’s vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, 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.
GeoVax, Inc.
CONTACT: Don Hildebrand of GeoVax, Inc., +1-404-727-0971,dhildebrand@geovax.com
Web site: http://www.dauphintech.com/
