GeoVax pursues HIV vaccine dual pathway
Finding this dual pathway will allow GeoVax researchers to conduct pivotal human effectiveness trials.
“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,” GeoVax CEO and President Robert McNally said. “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."
As of today, current HIV care and treatment has continued to rise in price, greatly impacting U.S. taxpayers. In 2009, HIV treatments cost $12 billion. In 2014, this cost rose to $17 billion and there is no sign that the price will reduce in the future.
"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,” McNally said. “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.
"We look forward to implementing our updated clinical strategy and advancing our vaccine directly into a pivotal Phase 2b clinical trial,” McNally said. “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."