FDA Grants IND 'Safe to Proceed Status' With Planned Human Clinical Trials Scheduled in April 2006 for GeoVax HIV/AIDS Vaccine
By PR Newswire Last Update: 3/14/2006 2:00:28 PM Data provided by
ATLANTA, March 14, 2006 /PRNewswire-FirstCall via COMTEX/ -- GeoVax Inc., an Atlanta, Georgia biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus - AIDS) and other infectious agents, today announced that the FDA [Food & Drug Administration] granted "Safe to Proceed" status to an "Investigational New Drug" [IND] application to conduct human clinical trials with GeoVax AIDS vaccines.
These human trials will administer 2 doses of our DNA vaccine to prime the immune response followed by 2 doses of our recombinant MVA vaccine to boost the immune response. Both AIDS vaccines are genetically engineered to express key AIDS virus proteins.
Human trials will first evaluate the safety and immune responses [indicative of potential protection against AIDS] induced by low doses of our DNA and recombinant MVA vaccines and then evaluate the safety and immune responses induced by high doses of these DNA and MVA vaccines.
The trial sites requesting approval to open the study include the University of Alabama in Birmingham, Saint Louis University, and the University of Maryland through the HVTN [HIV Vaccine Trials Network] which is funded and supported by the US NIAID [National Institute of Allergy and Infectious Disease].
Human trials testing the GeoVax HIV/AIDS vaccines are anticipated to begin in April 2006.
Note: Prototype GeoVax DNA and MVA HIV/AIDS vaccines previously demonstrated safety as well as effectiveness in preventing clinical signs of AIDS in 22 of 23 [96% protection] non-human primates for over 3 1/2 years while 5 of 6 non-vaccinated monkeys developed AIDS within 8 months post-AIDS virus infection.
This FDA "Safe to Proceed" status is a key step forward in testing and evaluating our DNA/MVA AIDS vaccines for their safety and protective potential in humans.
About GeoVax Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus - AIDS) and other infectious agents. Present goals include: developing AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting human trials for vaccine safety and effectiveness and obtaining regulatory approval of these vaccines in the USA and international markets. Global market estimates exceed $4 billion for effective and safe AIDS vaccines.
GeoVax Inc. recently signed an AGREEMENT AND PLAN OF MERGER with Dauphin Technology, Inc. (DNTK) with GeoVax the proposed surviving company controlling 67% of newly issued and outstanding stock and receiving additional operating capital.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of 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. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, 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.
SOURCE GeoVax Inc.
Posted by knicks321 on :
THIS IS A HUGE PRESS RELEASE
Posted by Danny K on :
agreed. huge... did u just hear this on subpennyradio ??
Posted by knicks321 on :
just saw the press release....subpenny giving it a good review?
Posted by knicks321 on :
taking a nice dip, now is a great time to get in
Posted by Danny K on :
ohh yea, i think its great news.... soon as u mentioned it here.... Simon had a caller recomending it. was just wondering if ur the caller? we are still talkin about it...lol
Posted by JohnnyRotten on :
It is interesting news so I bought some and it started retracing.
They filed a law suit aginst preferred shareholders for 18 million. So they could do real well if they win. It would add a lot of working capital to the company.
The merger hasn't happened yet so they don't officially own anything yet. I guess only the intent papers are in place.
Keep in mind they wouldn't be fighting over it if it wasn't valuable, at least that is the way I see it.
Also the clinical trials begin in April and could last a while. They tested monkeys for three and a half years.
If it works it could be used overseas much quicker.
It could be worth billions of dollars if successful.
Posted by knicks321 on :
looks like it coule be in for an afternoon run!!
Posted by knicks321 on :
ITS MOVING TODAY....cant believe everyone is overlooking this one!
Posted by knicks321 on :
alrite this closed up 16% due to an eod run...it has amazing pr...it just got approved for human trials for a medicine that had a 96% protection rate against HIV. no one interested because its not a .0001 stock? this is a legit company, with huge potential growth out of the penny land. and no im not a pumper i only own 1500 shares, this thing just needs exposure. o/s 99,552,000
Posted by JohnnyRotten on :
I got out to wait for the merger to be completed. Probably a mistake, but it is a little risky when they don't own anything yet.
Posted by CrashtehLine on :
![[Wink]](wink.gif)
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