CytoDyn Study of Bird Flu Vaccines Illustrates Subsidiary's Unique Opportunity
RESULTS IN PERSPECTIVE
Very large earning potentials, and the potential for significant improvements in global public health, have put DNA flu vaccines on the forefront of research by private companies and government researchers alike. There are several advantages to DNA vaccines because they are engineered in the laboratory and do not contain viruses that require strict manufacturing, transportation, and storage conditions like traditional vaccines. Anthony S. Fauci, M.D., Director of the National Institute of Allergies and Infectious Diseases (NIAID) said, "More broadly, development of this DNA vaccine technology has the potential to improve our production capacity for vaccines to prevent seasonal influenza and other diseases."
Several DNA vaccines have been developed that protect avian species and some mammals other than humans. The challenge has been to develop DNA vaccines that protect humans as effectively as they protect animals. A potential path for making progress in this regard is to reach beyond the traditional goal of creating antibodies to include the cell-mediated immune response as well. The NIAID tried this while developing an experimental vaccine that protects mice from the virus that caused the flu pandemic of 1918, albeit with antibodies alone, and the CDC has encouraged such research. One result of the present study was to identify a proprietary improvement of DNA vaccines that increased cell-mediated immunity 4-fold in mice.
Another result of the present study was to show that mammals can have a wide range of individual reactions to bird flu vaccines and less than a majority may respond (see multimedia elements). This is certainly true of the traditional type of vaccine used to protect humans against the bird flu, recently licensed by the FDA for marketing by Sanofi-Avantis (NYSE: SNY) despite protecting only 45% of the people who were vaccinated in clinical trials. This problem reflects the differences between the human immune system and the immune systems of different species. Attention to these differences resulted in a proprietary new method of vaccinating humans, the "prime boost" method licensed to AITI after encouraging results from previous animal studies.
Much fanfare has surrounded the gene gun being developed by PowderMed, a wholly owned subsidiary of Pfizer (NYSE: PFE). The gene gun is used to deliver a DNA vaccine for bird flu directly into human cells on gold spheres thereby increasing potency, albeit at the expense of creating massive new inventories of the device to replace the ubiquitous hypodermic. Gene guns are an established technology for genetically modifying plants and animals but some anticipate concerns about safety in humans, especially at a time when the FDA has a new mandate in that regard. PowderMed's DNA vaccine came from the same source as a newer one licensed to AITI and is an older version of it.
Two Highlights of The Study
-- Some proposals for making DNA vaccines more potent do not achieve that goal in practice, and some paradoxically make the vaccines less potent. This underscores the potential importance of the proprietary vaccination method licensed to AITI, given the encouraging results from previous animal studies.
-- There is a proprietary way of making DNA vaccines that increases the cell-mediated immune response 4-fold in mice, currently under option to AITI and potentially providing a competitive advantage.
COMPANY POSITION
In explaining the Company's interest in vaccines, CytoDyn's CEO, Allen D. Allen, cites the tort reform and other factors that have made vaccines highly profitable. Although vaccines were previously developed by only two or three major companies throughout the world, there are now companies as globally diverse as Dynavax (NadaqGM: DVAX) and Cytos (SWX: CYTN) with new vaccine technologies in development thanks to the very large market potential. In explaining the reasons for the present study, Allen notes the importance of precisely identifying the endpoints or product advantages that a clinical trial is intended to reveal and then designing the trial accordingly. As an obvious example, ImClone (NasdaqGM: IMCL) famously failed to demonstrate the efficacy of its important cancer drug Erbitux in its first attempt at a Phase III trial. "This is what we mean when we say, 'Science makes the difference,'" Allen concluded.
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LINKS
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CytoDyn http://www.cytodyn.com Dr. Fauci quote http://www.nih.gov/news/pr/jan2007/niaid-02.htm NIAID Cell-mediated immunity http://www.nih.gov/news/pr/oct2006/niaid-17.htm CDC Cell-mediated immunity http://www.cdc.gov/ncidod/eid/vol12no01/05-1237.htm Sanofi-Aventis http://en.sanofi-aventix.com Gene Gun http://synthesis.typepal.com/synthesis/2005/09/powdermeds_h5n1.html PowderMed http://www.powdermed.com Pfizer http://www.pfizer.com/pfizer/main.jsp Dynavax http://www.dynavax.com Cytos http://www.cytos.com ImClone http://www.imclone.com/favicon.ico
DISCLAIMER
This press release contains forward-looking statements that are not historical facts. The Company's management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements are necessarily estimates based upon current information and involve a number of risks and uncertainties. There can be no assurance that such risks and uncertainties, or other factors, will not affect the accuracy of such forward-looking statements. It is impossible to identify all factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, government regulation, managing and maintaining growth, victimization by white-collar offenders, and the effects of adverse publicity, litigation, competition, and other factors that may be identified from time to time in the Company's announcements.
Contact
CytoDyn, Inc.
Stacia Andrews/Corinne Allen, 1-505-988-5520
info@cytodyn.com
Posted: July 2007
