GeoVax Labs Begins Enrollment at Final Site for Preventative Vaccine; Next Step Is to Submit IND Application for Therapeutic Vaccine to FDA
Hires Clinical Research Organization
ATLANTA, Feb. 8 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today provided an update on its vaccine trials progress.
"The HIV/AIDS population continues to grow at an alarming rate, 60,000 new infections annually, and that's just in the United States. Preventing the spread of this disease and controlling infections through the development of vaccines remains our mission and our goal," stated Robert McNally, Ph.D., president and chief executive officer. "On the preventative front, our Phase 2a trial is now enrolling at two locations in Peru where sites were slow to open due to local government review. And we are making good progress with our therapeutic vaccine, as we completed a Pre-IND meeting with the U.S. FDA in December and are well into the process for submission of an IND for a Phase 1 trial. We look forward to discussing this progress with stakeholders at the BIO CEO meeting in New York City tomorrow.
"We have engaged a full-service Clinical Research Organization (CRO) to support our therapeutic human clinical vaccine trials. They will be providing assistance for clinical trial management; clinical, medical and safety monitoring; data management, biostatistics and medical writing services," stated Dr. McNally.
Preventative Clinical Trials - Phase 2a
The Phase 2a preventative trial has started enrolling patients at the last 2 of its 13 sites. "We are making great headway at the Iquitos and Miraflores sites in Peru," commented Dr. McNally.
The preventative trial, designated as HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN). The HVTN, funded and supported by the National Institutes of Allergy and Infectious Diseases (NIAID), is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The HVTN has sponsored over 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines. The results of these trials have merited only five Phase 2 trials. Progressing to Phase 2 was a significant step for GeoVax.
Therapeutic Clinical Trials - Preparing for Phase 1
To help serve those people who are already infected with HIV, the Company is testing its vaccine for the ability to supplant the need for drugs in HIV-positive individuals. Antiretroviral drugs, which have to be taken for life, have side effects and are expensive, costing on average $18,000 per year. GeoVax is currently preparing an Investigational New Drug application (IND) for its Phase 1 therapeutic trial for the FDA. Following receipt of the IND, the FDA has 30 days to respond. If there are no FDA concerns, the company can begin the trial.
This initial trial will be conducted in Atlanta and enroll individuals who began successful antiretroviral therapy within the first year of infection. The goal of this trial is to determine the safety and immunogenicity of the vaccine in patients with well-controlled infections who started on antiretroviral therapy drugs within six months of testing positive for HIV.
"Based on the success of the simian prototype of the GeoVax vaccine in controlling established infections in the non-human primate model, we believe our vaccine should be effective in at least some infected humans," said Dr. Harriet Robinson, Chief Scientific Officer and a developer of the vaccine. "Studies on the therapeutic potential of the simian prototype for the GeoVax vaccine have been conducted in Dr. Rama Rao Amara's laboratory at the Emory Vaccine Center and the Yerkes National Primate Research Center. These studies showed the vaccine achieving 100-fold reductions in viral RNA in infected non-human primates placed on drugs within four to five months of infection, then vaccinated while on drugs, and, once the vaccine response was in place, released from drugs."
BIO CEO & Investor Conference
Dr. McNally will present a corporate update at the 12th Annual BIO CEO & Investor Conference at 1:00 p.m. Eastern Time on February 9, 2010 in New York City.
The presentation will be webcast live and may be accessed by visiting the company's homepage or "Investors" tab at www.geovax.com. The webcast will be archived for 90 days.
GeoVax's unique two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses. Stimulation of both T cells and antibodies differentiates the GeoVax vaccine from many other vaccine candidates. GeoVax's DNA and MVA vaccines are used in a prime-boost protocol in which priming is done with the DNA and boosting with the MVA. Both the DNA and MVA express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like-particles. These particles contain proteins that mimic more than half of the components of the AIDS virus, but cannot cause AIDS. This multi-protein approach is designed to elicit a broad multi-target protective T cell response. The Env protein is designed to elicit a protective antibody response against the natural form of the virus envelope glycoprotein as well as protective T cells.
AIDS is an epidemic that can affect anyone, regardless of race, gender, age or sexual orientation. 33 million people are currently infected globally and it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, over a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with AIDS. Globally, HIV is the top killer among women of reproductive age.
HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B, and C. In 2008, antiretroviral treatment in low and middle income countries was restricted to about 3 million people. In the United States, about 50% of those who are infected are estimated to be on drug treatment.
About GeoVax Labs, Inc.
GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected people to prevent acquisition of HIV-1 and limit the progression to AIDS should a person become infected. GeoVax AIDS vaccines also may be effective as a therapeutic treatment (for people already infected with the HIV-1 virus).
GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Chief Scientific Officer, through a collaboration of colleagues at Emory University's Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.
GeoVax's AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $18 million IPCAVD grant awarded in late 2007.
Safe Harbor Statement
All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions on the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent AIDS 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, 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. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitation, risks detailed in the Company's Securities and Exchange Commission filings and reports.
SOURCE GeoVax Labs, Inc.