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J.R.E.:
GeoVax Starts Injections For Phase 2a Human HIV/AIDS Vaccine Trial In USA
Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 21 Feb 2009 - 1:00 PST

 
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GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based, publicly traded biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced the first injections in its Phase 2a Human Clinical Vaccine Trial for its candidate HIV/AIDS vaccine. The trial, designated 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 2a trials since 1992. Progressing to Phase 2 is a significant step for GeoVax. The Company is pleased to report that the first injections for the Phase 2a trial were conducted at the HVTN network sites at the University of Alabama, Birmingham, and Vanderbilt University, Nashville.

The trial will include a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients) and take place at 13 HVTN sites: 11 in North America and 2 in South America. Sites in the United States include Emory University, Atlanta; Harvard Medical School, Boston; Vanderbilt University, Nashville; University of Rochester; Fred Hutchinson Cancer Research Center, Seattle; the San Francisco Department of Public Health; University of Alabama, Birmingham and sites at Columbia University, Union Square, and the Bronx in New York City. In South America, participants are to be enrolled in Peru at sites in Iquitos and Miraflores (Lima).

"I am extremely pleased that our vaccine merited moving forward through the HVTN," said Harriet Robinson, Ph.D., developer of the vaccine and Senior V.P. of Research and Development at GeoVax. "This network provides a wide array of support for its clinical trials, from finances to statistical design and analysis; from community engagement to rigorous laboratory analysis. Working with the HVTN also affords us the input of the NIAID Prevention Science Research Committee, a committee with breadth of experience and knowledge in human vaccine development."

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 Ab response against the natural form of the virus envelope glycoprotein as well as protective T cells.

Dr. Paul Goepfert, principal Investigator of HVTN 205 and director of the University of Alabama trial site, said, "The road to an effective vaccine to prevent HIV infection is long and winding. It is vital to continue testing promising products. I am very pleased to aid in the further development of this important product in a phase 2 trial."

"For nearly 30 years since HIV/AIDS' discovery, researchers have been searching for a vaccine to combat its scourge," said Robert McNally, Ph.D., CEO and President of GeoVax Labs Inc. "Our Phase 1 trials found GeoVax's vaccines to be safe and immunogenic in humans. Good results from the Phase 2a human trial will build upon this foundation of safety and immunogenicity to support a Phase 2b efficacy trial."

In addition to the preventative vaccine entering Phase 2a, GeoVax also is working towards initiating human clinical trials testing its vaccines as potential therapies for people who are already infected with HIV. The goal of the therapeutic vaccination is to reduce the need of infected people for anti- viral drugs. Initial therapeutic trials will vaccinate infected people who are already on drugs to test the safety and immunogenicity of the vaccine in infected people. Therapeutic trials of a simian immunodeficiency virus (SIV) prototype of the GeoVax HIV vaccine in SIV infected primate animal models have held high promise that the GeoVax vaccine will be able to contribute to the control of HIV-1 in infected humans.

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 Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person ever become infected. GeoVax AIDS vaccines also may be effective as therapeutics, treatment of people already infected with AIDS virus.

GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and Development, 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 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 $15 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.

GeoVax Labs, Inc.
http://www.geovax.com

hahaha:

--- Quote from: J.R.E. on February 22, 2009, 07:11:35 PM ---GeoVax Starts Injections For Phase 2a Human HIV/AIDS Vaccine Trial In USA
In addition to the preventative vaccine entering Phase 2a, GeoVax also is working towards initiating human clinical trials testing its vaccines as potential therapies for people who are already infected with HIV. The goal of the therapeutic vaccination is to reduce the need of infected people for anti- viral drugs. Initial therapeutic trials will vaccinate infected people who are already on drugs to test the safety and immunogenicity of the vaccine in infected people. Therapeutic trials of a simian immunodeficiency virus (SIV) prototype of the GeoVax HIV vaccine in SIV infected primate animal models have held high promise that the GeoVax vaccine will be able to contribute to the control of HIV-1 in infected humans.


--- End quote ---
Does anybody here had any idea that when will the therapeutic clinical trial take place?
Sometimes I feel confused, therapeutic trial shall be much easy to get conclusion then preventive trial.  (Viral load remain constant or lower, no ART further need for a period of time).   Why don't GeoVax do the therapeutic clinical parallel with the preventive one? Is there any further concern?   

NYCguy:
I've been following Geovax for a while (also bought a little stock, so if it works i'll get cured and make a few $, lol).  There has been very little info about therapeutic trials, and everything seems to be running about a year behind, but I'm thrilled they have finally started the phase II preventatives.  I think part of the delay has been an attempt to improve delivery and production, which they are now partnering with a french company to help achieve. Not to mention funding.

The article below is the only recent one I've seen that mentions therapeutic trials to be started in 2009.  Let's hope...

http://biz.yahoo.com/prnews/090211/cg69290.html?.v=1

GeoVax Update Provided at the BIO CEO & Investor Conference 2009
Wednesday February 11, 8:00 am ET

ATLANTA, Feb. 11 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX - News), an Atlanta-based, publicly traded biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that Robert McNally, Ph.D., Chief Executive Officer and President, presented a corporate update at the Eleventh Annual BIO CEO & Investor Conference 2009, held at the Waldorf-Astoria Hotel, in New York.

Dr. McNally presented a corporate overview of GeoVax and its DNA/MVA vaccine technology, showcasing the scientific rationale and encouraging data from the Company's completed studies and trials. Among the points discussed by Dr. McNally were:

* World class science and collaboration with leading institutions. Dr. McNally informed the audience of unique scientific collaboration between Emory University, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), which led to the formation of GeoVax and the exclusive license of technology developed at these institutions.
    * Large market opportunity. Dr. McNally presented information on the very attractive market opportunity available for a successful HIV/AIDS vaccine. GeoVax's unique vaccine with its potential use in both preventative and therapeutic applications holds promise for not only addressing an unmet medical need, but also for commercial success.
    * Intellectual property. Dr. McNally briefly reviewed GeoVax's patent portfolio, consisting of over 20 issued and pending patents covering the Company's vaccine technology and manufacturing methods.
    * Status of Phase 2a preventative clinical trial. Dr. McNally discussed the current status of the Company's Phase 2a preventative human vaccine trial. He noted that clinical sites had been activated and prospective subjects are being identified.
  * Planned therapeutic clinical trials. Dr. McNally briefly discussed the company's plans for moving into therapeutic human vaccine trials in 2009 - for treatment of people already infected with the HIV-1 virus.
    * Selection of DNA vaccine component. The Company has recently reviewed results from its preclinical studies; comparing the performance of its two DNA vaccine candidates - JS2 and JS7 - and has determined that the JS7 DNA vaccine (currently being distributed for the Company's Phase 2a trial) provides the best opportunity for success. Dr. McNally stated that the final selection of JS7 will accelerate the company's moving forward with the therapeutic clinical trials process.
    * Efficient MVA manufacturing process. Dr. McNally reviewed the Company's current process for making the MVA portion of its vaccine through chicken embryos, and discussed GeoVax's ongoing collaboration with Vivalis, S.A. to develop a duck embryonic stem cell platform which can support large scale bioreactor production to meet future commercial demand.
    * Governmental support. Dr. McNally noted that GeoVax is supported in two significant ways through the federal government. GeoVax's Phase 1 human clinical trials, as well as the current Phase 2a trial are conducted and paid for by the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH. GeoVax is also the direct recipient (in October 2007) of a 5-year, $15 million grant by the NIH in support of its HIV/AIDS vaccine development efforts.
    * Financial strength. In addition to the financial and resource support provided by HVTN and NIH, Dr. McNally also talked about the $10 million financing facility currently in place through a common stock purchase agreement with Fusion Capital. He noted that this facility provides the Company with financial security and flexibility to meet its short-term operational and clinical objectives, but that additional financing would be necessary to progress into the later stages of clinical development.

moskimo:
can somebody bring these clinical tests and trials to south africa that is where the pendamic is raging

Alefou:
This is a very good news. I'm just scared of one thing... Of course a preventive vaccine would be huge ! and it would allowed us to have normal relationship with people which will be not scared of us anymore. But ! Imagine that a preventive vaccine is found before the therapeutic one... I'm scared that all the research on AIDS will go down and that they will not care of people infected (they will just wait that we die so that AIDS is removed from the planet .... )

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