The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of preventive HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from NIAID. The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington. For more information, go to www.hvtn.org.
About Global Solutions for Infectious Diseases
Global Solutions for Infectious Diseases (GSID) is a non-profit global health organization engaged in the development of diagnostic and preventive tools for infectious diseases, including HIV. GSID provides assistance to, and collaborates with, global public health organizations, private foundations, other non-governmental organizations and for-profit entities focused on public health issues and infectious diseases. The focus of GSID is to facilitate the access to affordable health solutions for the benefit of the people most in need, particularly in developing countries. For more information, go to www.gsid.org.
ATLANTA, GA--(Marketwired - Jun 30, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the conduct of the next human clinical trial of GeoVax's preventive HIV vaccine. The IND was filed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Phase 1 trial (designated HVTN 114) will be conducted by the NIAID-supported HIV Vaccine Trials Network (HVTN). The Company expects HVTN 114 to begin enrolling patients in September 2016.
HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 Phase 2a trial of the GOVX-B11 vaccine (concluded in 2012) and will test the ability of late boosts to increase the antibody responses elicited by the GeoVax vaccine. The late boosts will consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX(R) B/E, will be supplied by Global Solutions for Infectious Diseases (GSID). Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX(R) B/E, or (c) AIDSVAX(R) B/E alone.
Harriet L. Robinson, Ph.D., GeoVax's Chief Scientific Officer, commented, "HVTN 114 represents the first clinical study of the effect of late boosts, which include a protein boost on the GOVX-B11 DNA/MVA vaccine. The protein boost, AIDSVAX(R) B/E, is the same protein used to boost immune responses in the partially successful RV144 trial in Thailand. AIDSVAX(R) B/E is being used to gain an initial assessment of the effect of late boosts of GOVX-B11 while new proteins are being cGMP manufactured for future use."
The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of p
GeoVax Awarded NIH Grant for HIV Vaccine Program GeoVax, Inc.
ATLANTA, GA - (NewMediaWire) - June 29, 2016 - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company specializing in the development of human vaccines, announced today it has received a Notice of Award from the U.S. National Institutes of Health (NIH) for a Small Business Innovative Research (SBIR) grant in support of its clade C HIV vaccine development program for Africa. The grant award of $294,038 is for the second year of a two-year project period which began July 1, 2015, with a two-year project budget of $593,623.
The grant, entitled "Directed Lineage Immunizations for Eliciting Broadly Neutralizing Antibody," is supporting the preclinical testing in non-human primates of a vaccine designed for the clade C subtype of HIV prevalent in Sub-Saharan Africa. This project is using GeoVax's Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) vaccine technology, and builds on the GeoVax clade B HIV vaccine, GOVX-B11, which is designed for the epidemic in the Americas and Western Europe. GOVX-B11 has shown outstanding safety and reproducible immunogenicity in clinical trials involving 500 people in North and South America and the Company anticipates that the clade C vaccine will show similar promise. The grant was awarded to Dr. Arban Domi, GeoVax's Director of Vector Development, who continues to oversee its implementation.
Robert McNally, Ph.D., GeoVax's President and CEO, commented, "As our clade B HIV vaccine for North America and Western Europe continues progressing through human clinical trials sponsored by the National Institutes of Allergy and Infectious Diseases (NIAID), we are also pleased to have NIH/NIAID's support to advance the version of our vaccine for the clade C HIV subtype. We are confident that the animal trials funded by this grant will further demonstrate the promise of our MVA-VLP vaccine to address the HIV pandemic in sub-Saharan Africa where two-thirds, or 23 million, of the world's HIV cases reside."
.....being proposed by house and senate republicans:
The National Institutes of Health would receive $230 million to help with vaccine work, according to a summary provided to STAT. The Centers for Disease Control and Prevention would receive $476 million for work on mosquito control and other readiness and response activities.
The State Department and the United States Agency for International Development would receive $165 million to help prevent the spread of Zika-carrying mosquitoes in the United States, according to the summary.
The $1.1 billion in new funding would be partially offset by $750 million in spending cuts. The cuts would include $543 million from the Affordable Care Act’s transition fund for US territories, $100 million from another US Department of Health and Human Services fund and $107 million from the remaining Ebola emergency funding, according to a separate summary provided to STAT.
GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company specializing in the development of human vaccines, announced today that its Chief Scientific Officer, Dr. Harriet Robinson, gave an oral presentation at the American Society for Virology’s 35th Annual Meeting, held at Virginia Polytechnic Institute and State University in Blacksburg, Virginia on June 18-22, 2016.
Dr. Robinson’s presentation, entitled “Development of a Zika Vaccine”, was delivered today during the late-breaking Zika workshop at the conference, and is summarized below.
To rapidly develop a Zika vaccine, GeoVax is leveraging its Modified Vaccinia Virus Ankara (MVA) Virus-Like Particle (VLP) technology for the construction of a Zika vaccine. GeoVax MVA-VLP vaccines express viral antigens that assemble into VLPs within the vaccinated person using the highly potent, yet safe (replication deficient for mammalian cells) MVA vector. The MVA-VLP vaccines elicit both antibodies and T cells and hold promise as both single dose, and as prime-boost vaccines. Zika is a member of the flavivirus family that also includes yellow fever virus, dengue virus, Japanese encephalitis virus, West Nile virus, and others.
As many consider MVA to be a vector that is primarily valuable for boosting vaccine responses, Dr. Robinson introduced her talk with a brief update on the ability of an MVA-VLP vaccine to elicit protective immunity after a single inoculation. These data featured the GeoVax MVA-VLP Ebola vaccine which has recently shown complete protection against Ebola virus after single as well as two dose vaccinations in rhesus macaques. Dr. Robinson then went on to report that GeoVax is developing two MVA-VLP vaccine candidates for Zika virus using sequences from the Asian strain that recently spread to the Americas. This strain is associated with microcephaly in newborns and Guillian-Barre syndrome in adults.
The Company’s first vaccine is designed to express Zika pre-Membrane and Envelope (prME) proteins to produce Zika VLPs intended to elicit neutralizing antibodies that can block the Zika virus at its entry point into the host. In natural infections, flaviviruses produce non-infectious prME VLPs as well as infectious virus. The second vaccine expresses Zika VLPs plus an additional Zika non-structural protein that is shown with other flaviviruses to induce protective antibodies as well as cellular responses against flavivirus infections in humans. Zika virus forms by budding inside cells through the membranes of the endoplasmic reticulum and is then secreted from cells. Dr. Robinson showed the prME constructs expressing intracellular VLPs in multi-lamellar structures as well as provided evidence that VLPs were not only present in the cells in which they were formed, but also were secreted into the cell culture supernatant. Dr. Robinson ended the presentation with plans for animal testing and acknowledgement of the important role of collaborators at the Centers for Disease Control (CDC), the University of Georgia, and Emory University in the GeoVax vaccine development program.
“We are very pleased with the rapid progress of our Zika vaccine effort,” said Dr. Robert McNally, GeoVax’s President and CEO. “Our outside collaborators have provided valuable scientific insight and have helped speed us toward the testing of our vaccine for immunogenicity and efficacy in multiple animal models”.
....I'd take $3.34..........just to say I'm a millionaire. But lets not get too excited about anything yet. Good thing I don't need too much to live on....;)
.....hey Gambler. My only concern for getting to the higher numbers is the HIV situation. The grant/monies has to happen to move forward. It seems to me they've been stuck where they're at too long. I keep asking myself, why? What really are the reasons?
Its taken me years to average down here, now 300k @ .16 Even is it sells for $1 a share at least I have some ROI.
.....oops, I missed the decimal point. Hmmmm, I'm looking for $13.00....minimum. Hope I'm alive to see it though.
... I think what they're trying to do is prove their already existing platform of which they have multiple patents, can be used in lots of instances. I feel that if they can prove that then the HIV will get its funding. How can the NIH continue to drag their feet on a platform that works everywhere else?
eoVax Developing Vaccine to Treat Chronic Hepatitis B Infection
Expansion of Company's Pipeline of MVA-VLP Vaccines
ATLANTA, GA--(Marketwired - Jun 6, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today the launch of a program to develop a vaccine for treatment of chronic Hepatitis B infections.
The GeoVax vaccine will be based upon the Company's novel MVA-VLP vector platform, which has been proven safe in multiple human clinical trials of GeoVax's preventive HIV vaccine. This platform is also being used by GeoVax to develop preventive vaccines against Zika virus and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa).
Farshad Guirakhoo, PhD, GeoVax's Senior Vice President of Research and Development, stated, "Our MVA-VLP technology is well-suited for the development of a therapeutic vaccine against the Hepatitis B virus. There is a clear medical need to treat Hepatitis B infections, which affect millions of people around the world. Multiple vaccines exist to protect against Hepatitis B infection, but they cannot help patients already diagnosed with the disease. Although chronic Hepatitis B infections can be treated with drugs, the treatments do not cure 95% of patients; they only suppress the replication of the virus. Therefore, most people who start treatments must continue with them for life. Moreover, diagnosis and treatment options are very limited in resource/low income-constrained populations, which leads to a majority of patients succumbing within months of diagnosis. Within the scientific talent base at GeoVax, we have a good understanding of this disease and are familiar with the obstacles that must be overcome. We believe that our approach to vaccine design and method of treatment has significant merit. Our strategy is to use our therapeutic vaccine in combination with the standard-of-care treatment to reduce the duration of drug therapy, side effects, and potential drug resistance. Our goal is to significantly increase the current cure rate of Hepatitis B infections while reducing the overall treatment costs at the same time."
Commenting on the new program, Robert McNally, PhD, GeoVax's President and CEO, said, "Our entry into the HBV space further demonstrates the broad utility of our MVA-VLP platform and solidifies GeoVax as a leader in the next generation of vaccine developers. We are committed to developing a deep pipeline of products to address high-value, unmet medical needs in our quest to build shareholder value. We look forward to sharing the progress on our HBV vaccine program as it moves forward."
About Hepatitis B Virus
Hepatitis B is a contagious liver disease caused by the Hepatitis B virus (HBV). It is transmitted person-to-person by blood, semen, or other bodily fluids. This can happen through sexual contact, needle sharing, or mother to infant transmission during birth. For some people, Hepatitis B is an acute -- or short-term -- illness; but for others, it can become a long-term, chronic infection that may lead to serious health issues like cirrhosis or liver cancer.
The risk of chronic infection is related to age at infection. Approximately 90% of infected infants will develop chronic infections. As a child gets older, the risk decreases. Approximately 25%-50% of children infected between the ages of 1 and 5 years will develop chronic hepatitis. The risk drops to 6%-10% when a person is infected at over 5 years of age. Worldwide, most people with chronic Hepatitis B were infected at birth or during early childhood.
The CDC estimates that between 700,000 to 1.4 million people in the United States have chronic Hepatitis B virus infections, with an estimated 20,000 new infections every year. Many people are unaware that they are infected or may not show any symptoms. Therefore, they never seek the attention of medical or public health officials. Globally, chronic Hepatitis B affects more than 350 million people and contributes to nearly 800,000 deaths worldwide each year. Despite the fact that a preventive HBV vaccine is available, less than 5% of chronic Hepatitis B infections are cured.