ATLANTA, GA--(Marketwired - Apr 14, 2015) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines for Ebola and HIV using its novel platform technology, today announced its intention to pursue a dual pathway for advancing its preventive clade B HIV vaccine into pivotal human efficacy trials.
Robert T. McNally, Ph.D., GeoVax's President & CEO, explained, "On April 1, 2015, we announced that the HIV Vaccine Trials Network (HVTN) approved the concept protocol for a Phase 1 trial of our clade B HIV vaccine, coupled with late boosts of our MVA (modified Vaccinia Ankara) vaccine with or without a gp120 protein vaccine. As explained in that announcement, protein boosts were used in the one partially successful HIV vaccine trial (RV144). The forthcoming trial, HVTN 114, is expected to begin enrolling patients in late 2015 and will be fully funded by the National Institute of Allergy and Infectious Diseases (NIAID). While we believe the HVTN and NIAID approach may be the financially prudent step for advancing our vaccine prior to committing U.S. taxpayer funds to a much larger Phase 2b efficacy trial, we are investigating all options to accelerate our vaccine directly into pivotal Phase 2b clinical trials."
In her talk at the World Vaccine Congress on April 8, 2015, GeoVax's Chief Scientific Officer, Dr. Harriet L. Robinson, presented data showing the continuing increase in the U.S. taxpayer cost burden of HIV care and treatment efforts in the United States -- rising from $12 billion in 2009 to nearly $17 billion in 2014 and showing no slowing growth trend. These figures alone clearly demonstrate the critical need for a vaccine solution purely from a financial point of view. But the costs to society of an HIV infection also include patient time, lost productivity, and physical and emotional distress to patients and their families.
Dr. Robinson's talk featured the favorable immune response, durability, and safety characteristics of GeoVax's GOVX-B11 vaccine as demonstrated in successful Phase 1 and Phase 2a clinical trials involving 500 individuals. She also reviewed the Company's preclinical protection studies in non-human primates demonstrating the best protection currently being achieved by any HIV vaccines advancing in human clinical trials.
Dr. McNally added, "Based on all of these considerations, we believe it is not only in the best interests of our shareholders, but for the country at large, that we pursue a development strategy to accelerate and expedite our vaccine directly into pivotal Phase 2b efficacy trials, without the need for evaluating additional boosting regimens. Our intention is not to replace any of the efforts of the HVTN or NIAID regarding the ongoing 'protein boost' strategy and the commencement of the HVTN 114 trial or subsequent trials to further develop this concept. Rather, we plan a parallel strategy to secure funding for commencing a Phase 2b efficacy trial of our un-boosted GOVX-B11 vaccine. Each of these approaches has its own merits, but we strongly believe that our vaccine is ready for Phase 2b clinical trials."
Dr. McNally concluded, "We look forward to implementing our updated clinical strategy and advancing our vaccine directly into a pivotal Phase 2b clinical trial. We have sought the counsel and advice of many key stakeholders and HIV specialists, and management and our Board of Directors have determined our new strategy is the best way to proceed. We look forward to communicating the success of this strategy as we implement it."
About GeoVax's HIV Vaccine
GOVX-B11 is a DNA/MVA HIV vaccine, designed to stimulate both anti-HIV antibody and anti-HIV T cell immune responses. Both the DNA and MVA vaccines express the three major proteins of the HIV 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 natural form of the trimeric membrane-bound form of the HIV-1 envelope glycoprotein. Preclinical and clinical studies suggest that this feature generates antibody that binds sufficiently tightly to HIV, a virus that is not easily recognized by antibody, to prevent transmission. Studies have also demonstrated that the antibody response elicited by the GeoVax vaccine is highly durable (long-lasting), another important feature for an effective HIV vaccine.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases using our novel vaccine platform. Our current development programs are focused on vaccines against Ebola and Marburg viruses, and Human Immunodeficiency Virus (HIV). We believe our technology and vaccine development expertise is well-suited for a wide variety of human infectious diseases for which there is an unmet medical need, and we intend to pursue expansion of our product pipeline as resources permit.
Our vaccine platform supports production of non-infectious virus-like particles (VLPs) from the cells of the person receiving the vaccine. Producing non-infectious virus-like particles in the person being vaccinated circumvents the need to purify virus-like particles for inoculation. The production of virus-like particles in the person being vaccinated mimics a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent and control the target infection should it appear.
Clinical trials for GeoVax's preventive HIV vaccines have been conducted by the US National Institutes of Health-supported HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Disease (NIAID). Overall, GeoVax's vaccines, in various doses and combinations, have been tested in 500 humans. For more information, go to 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 HIV or Ebola infection 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.
Adam S. Holdsworth
PCG Advisory Group