Preventive Vaccine Program
•Phase 1 HVTN Trial - Patient enrollment for HVTN094, a Phase 1 clinical trial testing the safety and immunogenicity of GeoVax's second-generation vaccine, was completed in the first half 2013. This vaccine co-expresses granulocyte-macrophage colony-stimulating factor (GM-CSF) as an adjuvant and in non-human primate testing achieved a much higher level of prevention of infection than the Company's first-generation unadjuvanted vaccine. HVTN094 is being conducted by the HIV Vaccine Trials Network (HVTN) with financial support from the NIH. This trial is ongoing and will be completed in 2013.
•Phase 2 HVTN Trial - GeoVax is actively engaged in discussions with the HVTN regarding the design of a Phase 2 clinical trial of GeoVax's second-generation preventive HIV vaccine. The Company expects trial initiation in 2014, following successful completion of HVTN094.
Robert McNally, PhD, GeoVax's President and CEO, commented, "With the recent discontinuation of HVTN 505, a 2500-patient Phase 2b trial conducted by the National Institutes of Allergy and Infectious Disease (NIAID), our confidence in GeoVax's vaccine technology has been strengthened. The vaccine studied in HVTN 505 used an adenovirus vector, or carrier, of genetic material from the HIV virus, similar to the vaccine used in the Merck trial (STEP/Phambili) that was halted in 2007. In contrast, GeoVax's boosting vaccine uses a poxvirus vector (modified vaccine Ankara) which has been associated with clinical success. Our superb preclinical data and excellent safety profile give us reason to be enthusiastic about the prospects for our vaccine, which is now the leading preventive vaccine candidate for Clade B HIV.
"Our relationship with HVTN and NIAID continues to be strong," Dr. McNally continued, "and we look forward to advancing our HIV vaccine to the next stage of clinical development with their guidance and support."
About GeoVax's Technology
GeoVax's unique, two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses. GeoVax's DNA and MVA vaccines are used in a prime/boost protocol in which priming is done with the DNA and boosting with the MVA. Both the DNA and MVA express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like-particles. GeoVax's vaccines are unique in expressing virus-like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. In GeoVax's second generation vaccine, the DNA prime co-expresses GM-CSF with the virus-like particles, delivering a normal human protein that stimulates immune responses to the site of vaccination. 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.
AIDS can affect anyone, regardless of race, gender, age or sexual orientation. 33 million people are currently infected globally and it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, over a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with AIDS. 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 Clades AG, B, and C. GeoVax most advanced vaccines under development are designed to function against Clade B.
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