OTC:GOVX - GeoVax Labs, Inc. Definitely worth putting on your watchlist!

[GRooveLlama]

I urge everyone to keep a very close eye on this one! We could
soon be witness to history in the making!

Should positive news come soon regarding the FDA's opinion of
GeoVax's further development of their vaccine technology for
a therapeutic treatment for HIV/AIDS, this could finally position
the company as the world's greatest hope for combating this
global epidemic.

It's possible that we could hear results of the pre-Investigational
New Drug meeting with the FDA as early as next month (things will
be moving very quickly from now on as there is a great deal of
scientific and medical momentum surrounding their patented technology).
If GeoVax gets the green light to go ahead with the development of
their vaccine as a therapeutic treatment for individuals infected with
HIV/AIDS, the p.p.s. could surely skyrocket. 400% isn't too unrealistic
from its current price of only .20!

[FavStocks]

This on is on my watch list for sure. Its a drug with huge potential. The chance of Phase I being successful is about 70% based on historical FDA data. Its phase II and III where most the drugs fail

[GRooveLlama]

The FDA will certainly not shut this company down in Phase 2. That means
they will be the first company in history to get an HIV/AIDS vaccine to Phase
3. Likely as soon as next month the FDA will grant them permission to
develop the vaccine as a therapeutic treatment. News of this magnitude
could easily result in the p.p.s. doubling, in my opinion, with potential to go
much higher should such news bolster more support for their cause.

A snippet from something that I posted, earlier, on a Google Finance
message board:

"No offense, honestly, to your analysis gentlemen... but the number of
outstanding shares and how much revenue the company is generating
right now doesn't mean a thing. Financial support doesn't mean
anything. Everything's turning upside down now with the results out
of Thailand having been made public. You guys are grossly
underestimating the value of this data. A month ago I would have
agreed with all of these comments that you all are making but now I am
convinced the larger picture is being missed. There is not going to
be a reverse split anytime soon (there won't be a need for one, you'll
see); moreover, we should all see a market cap of close to one billion
dollars in the near future. Once the FDA releases a judgment this
news is going to drive the price way up (and the "news" basically
being that the vaccine technology HAS proven itself highly effective
and that GeoVax is the ONLY one with it (remember that GeoVax has the
best this technology has to offer bottled up tight with patents) and
at a far more advanced stage of development than its competitors and
that's KEY to investors. It's absolutely crazy to think that this is
going to remain a sub 50-cent penny stock for much longer... in a few
weeks time we're going to have to start seeing some smoke and that
will be the precursor to the imminent explosion..."


Shares of GOVX is currently trading at the ridiculously low price of only $0.19 each.

[bsamarah]

I read up on the compnay sounds promissing. However hard to find information from reputable sources that gives the other side of the argument. Do you know where I can find such info?

[GRooveLlama]

GeoVax Labs Requests pre-IND Meeting With FDA
ATLANTA, Sept 21, 2009 /PRNewswire-FirstCall via COMTEX/ -- (PR NewsWire)

"The FDA has 60 days from our submission to review our proposal and respond with questions or comments..."

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 announced that it has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss a proposed IND for GeoVax's therapeutic vaccine as a treatment for individuals infected with HIV/AIDS.

HIV affects the entire globe and comes in a variety of subtypes. Clade B is the predominant subtype in North America, where there are roughly 60,000 new infections each year. Globally, there are about 2.5 million AIDS infections per year, most primarily involving subtypes AG, B, and C. In 2007, UNAIDS reported 1.3 million people living with AIDS in North America and 33.2 million people living with AIDS worldwide.

"This pre-IND meeting with the FDA is a significant step toward meeting the needs of those individuals currently infected with HIV/AIDS. The FDA has 60 days from our submission to review our proposal and respond with questions or comments," stated Robert McNally, Ph.D., president and chief executive officer. "The need for a HIV/AIDS vaccine is clear, based on the continued increase of new infections in the United States, despite years of education and preventative measures. Current costs for oral medications and the numerous side effects of these drugs give further urgency to the need for a therapeutic vaccine," noted Dr. McNally.

A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The Phase 1 therapeutic protocol stresses safety parameters to minimize any risk to the volunteers. The protocol, conceived with collaboration from ARCA (AIDS Research Consortium of Atlanta), has specific objectives to optimize safety while evaluating the ability for the vaccine to elicit protective immune responses in vaccinated participants. The proposed trial is based on the achievement of excellent post vaccine viral control in animal trials conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University. The proposed human trial follows the precedents set in the preclinical animal trials and is a critical step towards developing a therapeutic vaccine for HIV-1 infected humans.

Submission of a request to the FDA for a pre-IND meeting is the first step in a process that is expected to take a number of months to complete. Commencement of the trial is targeted for the first quarter of 2010.

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 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, 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'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 $17 million IPCAVD grant awarded in late 2007.


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Encouraging HIV/AIDS Vaccine Trial Results Support GeoVax Labs, Inc. Strategy
ATLANTA, Sept 24, 2009 /PRNewswire-FirstCall via COMTEX/ -- (PR NewsWire)

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), was pleased to hear the announcement today of partial success in the recently completed Phase 3 trial in Thailand of a candidate HIV/AIDS vaccine owned by Sanofi-Aventis and Global Solutions for Infectious Diseases. The completed study represents the first HIV/AIDS vaccine trial to show prevention of infection.

Robert McNally, Ph.D., Chief Executive Officer and President stated, "The results are highly encouraging for the clinical studies of our HIV/AIDS vaccine and we congratulate the Thai ministry of Public Health for successful conduct of a groundbreaking trial that included 16,000 volunteers and was supported by multiple agencies including the U.S. Army and the U.S. National Institutes of Health (NIH)."

"The partial success of this trial is very important to the GeoVax vaccine, because the vaccine tested in Thailand, like the GeoVax vaccine, was designed to elicit both T cells and antibody," said Dr. Harriet Robinson, Senior Vice President of Research & Development. "The two vaccines that have failed in previous efficacy trials elicited only antibody or only T cells. This was the first efficacy test of a vaccine that elicited both antibody and T cells and is very encouraging for the GeoVax vaccine, because our vaccine generates higher frequencies of T cells and better quality antibody. Given what we know about the elicited responses observed in this study, and the similarities and differences between our vaccine and the Sanofi-Aventis vaccine, the GeoVax vaccine should be poised for a higher level of protective success than the 30% success rate achieved in Thailand," noted Dr. Robinson.

"Within the two main areas of focus for our HIV/AIDS vaccine - preventative and therapeutic - we continue to make progress," stated Dr. McNally. "The preventative version of the vaccine has advanced to a Phase 2a human clinical trial, which was initiated in February 2009 by the HIV Vaccine Trials Network (HVTN) and continues to have steadily increasing enrollment. On the therapeutic vaccine, we continue to plan out the details of a Phase 1 human clinical trial and expect to begin this trial, assuming U.S. Food and Drug Administration (FDA) concurrence, in the first quarter of 2010."

The Technology

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. 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. GeoVax is also investigating a potentially simpler regimen in which MVA is used for both priming and boosting. 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.

"One of the strong features of our vaccines is their stability during manufacture," said Dr. Robinson. "During development, we and our collaborators at the National Institutes of Health persevered to construct vaccines that showed solid stability under commercial manufacturing conditions. We did not advance a vaccine until we had demonstrated stability. We have available inventory and can readily contract manufacture additional product," added Dr. Robinson.

[chopstick73]

I am sure the FDA will agree but chances of it passing phrase II is slim.

[GRooveLlama]

The preventative vaccine is currently in a late Phase-2a stage of development and all indicators suggest that the natural progression to Phase-2b (a larger number of volunteers to be recruited) will come early, next year. Reaching Phase 3, seems to be only a matter of time, as the company has all the financial resources required. On occasion, the FDA may fast-track development of drugs that treat or cure life-threatening illnesses by abbreviating lengthy Phase 3 Clinical studies. Based on the GeoVax technology, a therapeutic vaccine should move very quickly towards marketing. The preventative vaccine, I believe, will eventually pass as well. GeoVax, upon receiving approval possibly as soon as next month, could have the therapeutic vaccine **ready to ship within a year (we're already at a stage where the vaccine remains extremely stable under manufacturing conditions) -- the FDA could, in fact, see reason to fast-track such technology due to its immense global need.

**GeoVax's CEO, Bob McNally has gone on record as stating that his company develops drugs, they do not market them. Any successful clinical data upon the start of Phase 1 for a therapeutic vaccine could result in a sale of technology to a large pharmaceutical. This possibility will grow in plausibility should news of the vaccine's effectiveness be highly positive; news expected to be heard over the next few weeks as the FDA reviews the Investigational New Drug Application for the vaccine's therapeutic indication.

[moeblack1]

Fox news stated this GOVX is a Fluke

[GRooveLlama]

Fox News made no such statement; however, they may have covered a story in which a group of scientists reviewing claims by researchers from the U.S. Army and Thailand that they have found the first vaccine that provided some protection against HIV, but in fact did not release publicly, data based on a second analysis which suggests that their initial findings may be a fluke. This is according to AIDS scientists who have reviewed all available data from the Thailand studies. Additional data is suppose to be made public on October 19th. We may then discover how statistically significant the data truly is.

[moeblack1]

does anyone else have an opiniion about govx