GeoVax Lab Company Profile

The world could have a new vaccine designed to kill the AIDS virus in as little as three to four years according to an Atlanta-based group working on the vaccine.

It is a scientific advance that could save tens of millions of lives, and it is being developed on the campus of Emory University.

The work has been going on quietly for the last 15 years. But now it appears headed for the bell lap in the race to prevent the disease.

And the Atlanta-based group may be way ahead of the rest of the world.

The GeoVax lab at Emory is smaller than many garages. And yet the small modular building may be where the battle to end the reign of one the world's biggest killers could be won with a vaccine to prevent AIDS.

"We're getting results back that indicate we're getting very strong immune responses in these individuals these people who received our vaccine," said Don Hildebrand, the president and CEO of GeoVax Inc., the company spearheading the research in collaboration with Emory, the Centers for Disease Control, and the National Institutes of Health.

The vaccine uses a decoy virus with some of the genetic material of the aids virus but not enough for anyone to ever get the disease itself from the shot, according to Dr. Harriet Robinson, Ph. D., of the Emory Vaccine Center.

"It exposes your immune system to a pathogen like a virus or bacteria so before you've seen it you set up memory cells,” Dr. Robinson said, “and then these memory cells mobilize should you get the actual infection."

The test trials have been so successful that the vaccine is now more than a year ahead of schedule.

AIDS is considered the most lethal infectious disease in the world, and its incidence is growing rapidly.[World Health Organization - WHO]

Globally, an estimated >40 million people are infected, >6 million are infected yearly, >22 million people have died of AIDS, >3 million are dying annually and 68 million are projected to die by 2020.

In the USA, over one million people are infected. Over 10 million are infected in each of India and China. It is estimated that sub-Sahara African populations have over 25 million people infected with AIDS virus.
The incidence of European and especially Eastern European cases of AIDS is increasing.

Vaccine sales' estimates exceed $4 billion per year for a safe and effective vaccine designed to prevent clinical signs of AIDS.[IAVI - International AIDS Vaccine Initiative - Report 13 June 2005]

"Actually another two trials are starting later this year using different combinations of our vaccine and different administration programs,” said GeoVax CEO Hildebrand. “And following that presuming everything goes well we'll be starting a phase two program at the end of the year."

The vaccine works using a one-two pharmaceutical punch to prime the body then kill the virus.

“It raises both antibodies that can block the virus and it raises white blood cells called t cells that can kill the virus infected cells,” said Dr. Robinson. “So it really has two methods of controlling an HIV/AIDS infection once it enters the body."

The vaccine’s success with the simian AIDS virus has been nothing short of remarkable. Not only did the vaccine prevent the infection, it kept it under control for the monkeys that already had it, putting it in a kind of remission.

Researchers believe the same benefits await human subjects.

GeoVax Reports Progress on Its AIDS Vaccine Technology

ATLANTA, July 7 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta based, publicly traded biopharmaceutical company specializing in the prevention and treatment of infectious diseases, today provided an operational update on the company's progress towards entering Phase 2 preventative human clinical trial testing and plans to proceed into therapeutic human trials with its AIDS vaccine. Five successful human trials evaluating GeoVax AIDS vaccines have previously been reported.

Planned Phase 2 Human Clinical Trial for Prevention of AIDS

The Company's Phase 2 trial, conducted by the U.S. National Institutes of Health (NIH) supported HIV Vaccine Trials Network (HVTN), will involve 225 healthy volunteers from the United States and South America, and will further evaluate the safety and immunogenicity of the GeoVax preventative vaccine (vaccine administered prior to infection with the HIV virus). In Phase 1 trials, both 1/10th dose and full dose of the GeoVax vaccine elicited anti-HIV T-cells, whereas the full dose was required to elicit good frequencies of antibody to the HIV Envelope glycoprotein. The larger Phase 2 human trial will broaden the base of safety and immunogenicity data for the full dose of the GeoVax AIDS vaccine with a view to protecting recipients from developing AIDS should they be exposed to the virus. The planned Phase 2 human clinical trial is currently scheduled to start early this fall, subject to FDA approval.

Robert T. McNally
Dr. Robert McNally graduated with a Ph.D. in Biomedical Engineering from the University of Pennsylvania and has over 28 years of experience in academic and corporate clinical investigations, management, research, business, quality and regulatory affairs.
Dr. McNally is the President and CEO of GeoVax. Previously, he served as President as well as VP of Quality Assurance of Cell Dynamics, a company he co-founded. Cell Dynamics worked with organ and tissue procurement organizations for the recovery of human tissue processing these tissues into cellular components necessary for research and development, pharmaceuticals and cell therapy. In 1984, Dr. McNally co-founded CryoLife, Inc., a company specializing in the cryopreservation of human tissue for transplant. During his 14 year association with CryoLife, it grew to $50M in revenue, became a public company on NYSE and received world recognition as a leader in transplant technology.
He is a Fellow of the American Institute of Medical and Biological Engineers, serves on the board of the Petit Institute for Tissue Engineering at Georgia Tech and is Past Chairman of the Georgia Biomedical Partnership and recipient of its 2005 Biomedical Industry Growth Award.

Mark W. Reynolds
Mr. Reynolds is an experienced financial manager and business advisor with an in depth knowledge of SEC reporting and compliance. Having spent the past seventeen years working in both high growth and restructuring environments, Mr. Reynolds has worked with a number of start-up companies designing financial systems and procedures from the ground up.
Most recently, Mr. Reynolds served as the Chief Financial Officer, Company Secretary, and Controller at Cytrx Corporation, a publicly held biomedical firm based originally in Atlanta Georgia. He also served as the CFO and Controller for three of the company’s wholly owned subsidiaries. During his tenure at Cytrx, he maintained relationships with the Board of Directors, Investors, NASDAQ Representatives, Management Team and Staff.
Mr. Reynolds is a Certified Public Accountant and earned a Masters Degree in Accounting from the University of Georgia.

Harriet L. Robinson

Dr. Robinson is the developer of GeoVax' HIV-1 AIDS vaccine technology. One of the world's leaders in AIDS vaccine research, she currently serves as Senior Vice President of Research and Development for GeoVax. Previously, she was Chief of the Division of Microbiology and Immunology at the Yerkes National Primate Research Center and the Asa Griggs Candler Professor of Microbiology and Immunology at Emory University.
Dr. Robinson has published extensively on HIV-AIDS vaccine research as well as viral-induced cancers. Her pioneering studies on the development of DNA vaccines demonstrated not only that DNA could raise protective immunity for viral infections, but also identified methods of DNA delivery that could be used to control the type of immune responses raised by DNA vaccines.

Her early work with HIV vaccines demonstrated that DNA alone would not be sufficient to raise protective immunity for HIV. She then combined DNA with protein boosters or live viral-vectored boosters to show that the most effective control was through a combination of DNA prime and viral-vectored boosters. Her most recent work has developed single mutiprotein expressing DNA, and working with the NIAID-NIH, a single poxvirus vector (MVA) has been developed to be used for priming and boosting. It is these vaccines that GeoVax has licensed for commercial development.

Dr. Robinson has published extensively on HIV-AIDS vaccine research with more than 130 referred scientific journal publications, 45 monograph reviews and 6 book chapters authored. She has consulted for the US National Insitutes of Health, the US Food and Drug Administration, the Bill and Melinda Gates Foundation, and the World Health Organization.
Dr. Robinson received her B.A. from Swarthmore College and took her PhD in Microbiology from Massachusetts Institute of Technology. She has been elected to the American Academy of Microbiology.

Andrew J. Kandalepas
Mr. Kandalepas was formerly the Chief Executive Office and Chairman of the Board of Dauphin Technology, Inc., Under his leadership, which began in 1995, Dauphin Technology developed and marketed several well known high tech products, including, miniature hand held computers and Set Top Boxes. During his tenure at Dauphin, Mr. Kandalepas was successful in raising in excess of $60M in private and public capital as well as expanding Dauphin’s shareholder base from 400 shareholders in 1995 to approximately 25,000 shareholders.
Mr. Kandalepas has extensive career as an entrepreneur and executive manager which spans more than 30 years. Following 12 successful years with GTE and Motorola, he founded Cadserv Corporation, a privately owned Engineering and Circuit Board Solutions boutique service provider to major electronic OEM’s.
Mr. Kandalepas is an active participant in the local Greek community and served as a founder of the St. Athanasios Greek Orthodox Seminary in Woodstock, Illinois. He earned his Electronics Engineering Degree in 1974 from the DeVry Institute of Technology.

ATLANTA and NANTES, France, July 22 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, together with Vivalis (NYSE Euronext: VLS), a French biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and proteins, announced today the signing of a letter of intent (LOI) for joint collaboration and commercial license on the use of Vivalis' EBx(R) technology, to manufacture the MVA component of the GeoVax HIV-1 vaccine.

This agreement between GeoVax and Vivalis creates a worldwide strategic partnership between Vivalis and GeoVax, designed to combine Vivalis' cutting-edge vaccine manufacturing technology with GeoVax's promising HIV vaccine.

The breakthrough manufacturing technology developed by Vivalis, and now to be further developed through collaboration with GeoVax, will create a new standard for manufacture of the MVA component of the GeoVax HIV/AIDS vaccine, making present manufacturing technologies which have limited production capabilities, less competitive. Vivalis' EBx(R) manufacturing platform, with its increased effectiveness, superior quality and reliability, will speed time to market MVA vaccine product availability in ample quantities to meet sizeable demand and expectedly at a lesser cost.

'Partnering with Vivalis and its cutting-edge technology is extremely significant, and a giant step forward for efficient manufacturing of our 'MVA' HIV/AIDS vaccine component,' stated Robert McNally, President and CEO, GeoVax.
'Vivalis is pleased to enter in this collaboration with GeoVax, one of the most advanced companies worldwide in the field of HIV vaccine development. This agreement aims at developing a Vivalis proprietary upstream-downstream process for the production of MVA vaccines and EBx(R) technology licensing. GeoVax becomes a strategic partner and joins an elite worldwide consortium in the field of development, purification and production of MVA based vaccines,' said Franck Grimaud, Vivalis CEO.

Safe Harbor. The Materials at the Site may contain various forward-looking statements and which may be based on or include assumptions, concerning the Featured Company's operations, future results and prospects.
These forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the "safe harbor" provisions of the United States' Private Securities Litigation Reform Act of 1995, TheWallStWhisper.Com provides the following cautionary statement identifying important economic, political and technology factors which, among others, could cause the actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.
Such factors include the following:
(1) changes in the current and future business environment, including interest rates and capital and consumer spending;
(2) competitive factors and competitor responses to GeoVax Lab initiatives;
(3) successful development and market introductions of anticipated products;
(4) changes in government laws and regulations, including taxes;
(5) unstable governments and business conditions in emerging economies;
(6) continuation of the favorable environment to make acquisitions, domestic and foreign, including regulatory requirements and market values of candidates

Patents

GeoVax is aggressively pursuing a strong patent position on the proprietary technology developed in our collaboration between Emory University, the NIH, and the CDC. Patent applications are being filed with the USA Patent and Trademark Office and in specific international markets (countries).

Patent applications include provisions to cover our DNA and MVA based AIDS vaccines, their multi-protein components, composition, structure, claim of immunization against multiple subtypes of HIV, routes of administration, safety and other related factors. Patent claims filed for our vaccines include provisions for protection against two diseases: HIV/AIDS and smallpox.

GeoVax has a major Patent Portfolio protecting our AIDS vaccine technology with:

5 Issued Patents controlling the AIDS vaccine manufacturing process (exclusive rights).
12 Filed Patents in the USA and several other key countries on various components and compositions of our AIDS vaccine (exclusive rights).
4 Approved Patents licensed from the NIH related to the ability of our MVA vector vaccine as a vehicle to deliver HIV virus antigens, and also to induce an immune response in humans. These are key licensed patents for the use of MVA as a method for delivering our HIV-1 antigens as an AIDS vaccine.

Additional LINKS:

<http://www.hvtn.org/science/trials.html>
<http://chi.ucsf.edu/vaccines/>