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CYDY News CytoDyn Announces Progress With DNA Pre-Vaccines for Influenza

NEW YORK--(BUSINESS WIRE)--CytoDyn, Inc. (OTCBB:CYDY) announced today that optimization of the Company’s DNA-based pre-vaccines for influenza (the flu) will be reported in an upcoming issue of the Journal of Virology on line (www.jvi.asm.org). The encouraging results of the optimization technique (known as “codone optimization”) are described in a paper by S. Xang, J. Taffe, C. Parker, A. Solórzano, Hiong Cao, Adolfo García-Sastre and Shan Lu, from The University of Massachusetts Medical School, Worcester, MA, and the Mount Sinai School of Medicine, New York, NY.

CytoDyn’s Product Development Team is preparing to apply to the FDA for a pre-IND meeting next year to begin clinical trials of a bivalent DNA-based pre-vaccine for influenza. The initial product to be tested in human subjects is designed to use a person’s own cells to teach the immune system to recognize the current strains of influenza A (the seasonal flu). If successful, the Company will then produce a polyvalent product intended to protect the human population against the many known strains of avian and mammalian influenza that are expected to cause a virulent influenza pandemic in the future. Most recently, this occurred in 1957 with the Asian flu pandemic. Even the seasonal flu poses a risk for the elderly, the very young, and those with chronic diseases, resulting in some 200,000 hospitalizations and 36,000 deaths in an average year.

The advantage of the DNA-based product is that the virus is not needed for manufacturing. Since other vaccines require some, or all, of the virus for manufacturing, a new flu virus must emerge and begin spreading before a vaccine can be manufactured and tested. Since the flu virus changes every year, it is especially well suited for the Company’s DNA pre-vaccines, which eliminate the need to wait for the new virus to spread, according to CytoDyn’s CEO Allen D. Allen. The need to isolate the virus has caused shortages in the past, and there are current delays in delivering vaccines, such as those offered by GlaxoSmithKline (NYSE:GSK). This has resulted in the cancellation or postponement of flu clinics across the U.S. Another major supplier of flu vaccine, Sanofi Pasteur (NYSE:SNY), recently announced a three-week lag in production.

The exclusive right to commercialize DNA-based pre-vaccines for influenza was licensed from the University of Massachusetts Medical School by Advanced Influenza Technologies, Inc., a wholly owned subsidiary of CytoDyn, Inc. The technology transfer was managed by Utek Corporation (AMEX:UTK).

CytoDyn is presenting at the Rodman & Renshaw 8^th Annual Healthcare Conference today in New York, NY. Dr. Dorothy Bray, Chair of the Company’s Scientific Advisory Board, will be making the presentation, which can be viewed or downloaded from the Investors page of the Company’s website at www.cytodyn.com. The Company’s presentation will also cover Cytolin®, a targeted immune therapy for HIV/AIDS. Cytolin®, which has extensive human experience, uses the immune system to control the infection rather than attacking the virus directly. This addresses the emerging problem of multi-drug resistance and could provide salvage therapy for those patients who are running out of options.

This news release contains forward looking statements. Forward looking statements are 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.