11/13/2019 | Press release | Distributed by Public on 11/13/2019 11:44
Clinical Trial Expected to Commence in Early 2020
ATLANTA, GA, November 13, 2019 - GeoVax Labs, Inc. (OTCQB: GOVX) announced today its participation in a collaborative effort led by researchers at the University of California, San Francisco (UCSF), to develop a combinational therapy aimed at inducing remission in HIV-positive individuals (a 'functional cure'). The studies will be conducted with funding from amfAR, The Foundation for AIDS Research.
The proposed clinical trial will enroll 20 HIV-infected adults who are on stable and effective antiretroviral therapy (ART). The therapeutic regimen to be tested involves a combination of vaccinations (DNA priming and MVA boosting), administration of broadly neutralizing antibodies (bNAbs) and a Toll-like receptor 9 (TLR9) agonist. GeoVax will provide its novel boost component (MVA62B) for use in the studies. MVA62B is the boosting component for GeoVax's preventive HIV vaccine (GOVX-B11) which has successfully completed a Phase 2a clinical trial and is awaiting funding in support of a Phase 2b pivotal trial.
The planned trial, the most comprehensive test to date for the ability of synergistic approaches to control HIV infection, is led by Dr. Steven Deeks of UCSF, a world leader in therapeutic approaches to HIV infections. The primary objectives of the trial will be to assess the safety and tolerability of the combinational therapy and to determine the viral load 'set-point' during a treatment interruption. Secondary objectives will be to assess immune responses and changes in viral reservoir status. Patient enrollment for the clinical trial is expected to commence in early 2020.
Farshad Guirakhoo, PhD, GeoVax's Chief Scientific Officer, commented, 'In a previous therapeutic Phase 1 clinical trial conducted by GeoVax, we demonstrated that our vaccine can potently stimulate production of both CD8+and CD4+ T cells in HIV-positive individuals - the intended use of the MVA62B vaccine in the proposed UCSF therapeutic study. Our vaccine also has a well-documented safety profile in >500 humans. We are hopeful that the combination of technologies in these studies will yield a promising regimen to purge the latent HIV reservoirs and achieve a much-needed functional cure for HIV.'
'It is exciting to see this trial becoming a reality' said Harriet Robinson, PhD, CSO Emeritus of GeoVax. 'Dr. Deeks and UCSF have cohorts of infected individuals which are uniquely suited to this trial. The protocols, regulatory submissions and obtaining the products for this multi-product approach to HIV control have been in process for well over 2 years. We will learn an enormous amount from the outcome, and truly hope we will achieve improved drug-free control of viremia and reductions in viral reservoirs'.
David Dodd, GeoVax's President and CEO, stated, 'Finding a cure for HIV/AIDS remains an elusive but critical goal, and GeoVax is pleased to be a contributor to this important effort. While current antiretroviral therapy is effective at suppressing the viral load of HIV-infected individuals and preventing progression to AIDS, the long-term use of ART can lead to loss of drug effectiveness and can come with severe side effects. Additionally, the financial burden of drug and other medical costs to both the individual and to society at large is staggering, with average lifetime medical costs of treating an HIV-positive individual in the U.S. estimated to exceed $350,000.'
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using a novel patented Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP immunogens within (in vivo) the person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
GeoVax's current development programs are focused on preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against chronic Hepatitis B infections and multiple cancers. The Company has designed the leading preventative HIV vaccine candidate to fight against the subtype of HIV prevalent in the commercial markets of the Americas, Western Europe, Japan, and Australia; this program is currently undergoing human clinical trials managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH). In addition to the UCSF combinatorial trial, GeoVax's HIV vaccine is also part of collaborative efforts with American Gene Technologies International, Inc. (AGT) to apply its innovative gene therapy approach toward a functional cure for HIV. For more information, 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 targeted infections in humans, GeoVax's 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.
GeoVax Labs, Inc.