ATLANTA, GA--(Marketwired - Mar 14, 2017) - GeoVax Labs, Inc. (OTCQB: GOVX) announced today its collaboration with American Gene Technologies International Inc. (AGT) for the conduct of a Phase 1 clinical trial investigating the companies' combined technologies as a functional cure for HIV infection.
AGT intends to conduct a Phase 1 clinical study with HIV-positive individuals to test the safety and feasibility of protecting them with modified CD4+ T cells using AGT's proprietary lentiviral vector technology. Pursuant to the collaboration agreement, GeoVax will provide to AGT its MVA-VLP HIV vaccine for use in the study. T cells obtained from vaccinated individuals will be programmed by AGT's lentivirus vector and infused back into the study participants as a therapeutic cell product.
The primary objectives of the trial will be to assess the safety and tolerability of the therapy, with secondary objectives to assess immune responses and changes in viral status. The overall goal of the program is to develop a functional cure for HIV infection.
Robert McNally, PhD, GeoVax's President and CEO, commented, "Finding a cure for HIV/AIDS remains an elusive goal. While current antiretroviral therapy (ART) 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. The lifetime medical costs of treating an HIV-positive individual in the U.S. is estimated to exceed $500,000. Therefore, any new treatment regimen that allows patients to reduce, modify, or discontinue their antiretroviral therapy can offer measurable quality of life benefits to the individuals and tremendous value to the marketplace."
Dr. McNally continued, "We are pleased to be a part of this program with AGT and look forward to collaborating with them on this clinical trial. In a previous Phase 1 clinical trial, we demonstrated that our vaccine can potently stimulate production of CD4+ T cells in HIV-positive individuals - the intended use of the MVA-VLP HIV vaccine in the proposed AGT study. Our vaccine also has a well-documented safety profile in humans. We are hopeful that the combination of the GeoVax and AGT technologies will yield a promising regimen to achieve a much-needed functional cure for HIV."
Jeff Galvin, AGT's CEO, commented, "HIV/AIDS continues to be a global epidemic that exacts an enormous toll on individuals, their families, and society. The burdens and costs imposed on individuals are substantial. Even with the existence of highly active antiretroviral therapy, access to treatment is not assured, especially in developing countries. AGT is extremely optimistic that we can significantly improve the quality of life for HIV-positive individuals, encourage more infected persons to seek care, reduce individual and societal burden, and in the long term, broaden access to highly-effective treatment options."
About American Gene Technologies International Inc.
American Gene Technologies International Inc. (AGT), www.americangene.com, is an emerging gene technology company with a broad, robust lentiviral delivery platform evolved over ten years of advanced development. The anticipated HIV clinical trial will transition AGT from a pre-clinical to clinical stage company. AGT has developed an extensive patent portfolio surrounding its lentiviral platform innovations that accelerate the development of a wide variety of drug candidates. This platform allows AGT to pursue exciting clinical "cures" in large and orphan indications, complex diseases, and monogenic disorders. AGT's proprietary platform technologies provide reusable components that allow AGT and its collaborators to create new drugs in a fraction of the time of traditional drug development processes and other drug companies. For more information, visit www.americangene.com.
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company's 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 for chronic Hepatitis B infections and cancers. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. 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.