January 10, 2013 09:00 ET
Initial Data Expected in Late 2013
ATLANTA, GA--(Marketwire - Jan 10, 2013) - GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.
The primary goal of this study is to document the safety and immunogenicity of GeoVax's vaccine in HIV-positive patients with well-controlled infections using oral HIV drug medication. Following vaccination, the trial includes a short period of drug-interruption to evaluate the ability of the vaccine to control the infection in the absence of continuing drug therapy. The Phase 1/2 trial (designated GV-TH-01) consists of priming with a recombinant DNA vaccine followed by boosting with a recombinant modified vaccinia Ankara (MVA) vaccine. The vaccine regimen elicits both antiviral antibody that can block infection and antiviral T cells that can recognize and kill infected cells. The trial is being conducted at the AIDS Research Consortium of Atlanta, the Alabama Vaccine Research Center at the University of Alabama, Birmingham and the AIDS Research Alliance of Los Angeles.
Robert McNally, Ph.D., President and CEO of GeoVax, stated, "This pilot study is our first trial investigating use of a therapeutic vaccine to address the need for a treatment that is better tolerated and less costly than the HIV oral medications currently available. We anticipate having meaningful data from the program later this year."
Harriet Robinson, GeoVax's Chief Scientific Officer, commented, "Our next step planned for our therapeutic vaccine development program is a Phase 1 clinical trial to investigate the use of our vaccine in combination with standard-of-care drug therapy in young adults. This trial will likely be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT). One of the hopes for therapeutic vaccination is that combining a vaccine with drugs will allow the eradication of virus from an infected individual. Drugs primarily prevent infection whereas a vaccine can both block infection and kill infected cells."
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. 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 a Phase 1 study supported a Phase 2a trial that was completed in the 3rd quarter of 2012.
GeoVax's 2nd generation preventive vaccine is currently in phase 1 testing and is planned to progress to phase 2 efficacy testing, given safety and immunogenicity are as expected. Overall, the GeoVax vaccine, in various doses and combinations, has been tested in close to 500 humans. GeoVax is also enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.
HIV infection, which can lead to AIDS, is a pandemic that can affect anyone, regardless of race, gender, age, or sexual orientation. 33 million people are currently infected globally; it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, more than a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with HIV. Globally, HIV is the top killer among women of reproductive age. HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B and C. GeoVax vaccines are currently designed to function against clade B.
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.
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