CytoDyn Completes Safety Testing of Cytolin®: Benchmark for Improved Treatment of HIV/AIDS

SANTA FE, N.M.--CytoDyn, Inc. (Pink Sheets:CYDY) has completed safety testing of its current inventory of Cytolin^®, the Company’s immune-system modulator for managing HIV disease and the public health crisis afflicting communities where the infection is spreading due to unprotected sex and the other risk factors for AIDS. Tests for specific adventitious agents and other quality parameters following purification were performed by the manufacturing facility, Vista Biologicals Corporation of Carlsbad, California. The other safety tests, including in vivo general safety using two animal species, were performed by WuXi AppTec, a fully integrated pharmaceutical, biotechnology and medical-device company with facilities in St. Paul, Minnesota. WuXi AppTec provides R&D services to the biotechnology industry. Since the product is intended for use in a clinical trial, the tests conducted were those required for each new batch of a biologic agent manufactured for use in human research. The Company believes that the test results satisfy the current safety standards for the manufacturing of drugs belonging to the class of biologics. The results are summarized in the table below.

About Safety Testing

Product safety testing evaluates the quality of the manufacturing process in order to avoid risks to the health of human subjects that can arise from the way a particular lot of a drug was manufactured. The intrinsic safety of a drug intended for use in humans can only be ascertained from the response of human subjects to that drug. In previous human studies, multiple infusions of Cytolin^® were well tolerated, as reported in a newly released documentary and at a previous Conference on Retroviruses and Opportunistic Infections (CROI) by the Principal Investigator, Donald W. Northfelt, MD, then at the Eisenhower Medical Center in Palm Desert, California.

About Cytolin^®

Cytolin^® is a first-in-class immune modulator intended for use in combination with antiretroviral drugs in order to increase the effectiveness of the drugs used to manage HIV and AIDS while reducing the costs of treating those diseases. In part, Cytolin^® is designed to achieve these goals by preventing the emergence of drug-resistant strains of HIV. Unlike the other drugs used to treat HIV and AIDS, Cytolin^® does not promote resistance due to natural selection because it is not an antiviral drug. Rather, Cytolin^® is based on research revealing the reasons why chimpanzees can carry chronic HIV infection without ever developing AIDS and is intended to give humans a similar advantage.

For more information, watch the newly released 6-minute documentary “Point of Fear” on YouTube at http://www.youtube.com/watch?v=JhpI50YRQyQ.

Status of Cytolin^®

The Company is currently engaged in confidential negotiations with a major academic institution in the Eastern United States for the purpose of having the next clinical trial of Cytolin^® conducted by a thought leader in the field under an Investigator’s IND. The purpose of the study would be to confirm and elaborate the immunologic mechanisms believed responsible for the clinical benefits observed in earlier human studies of Cytolin^®. However, the Company cannot guarantee that such a clinical trial will be successfully mounted or that the study will be successfully completed or that the research will produce the expected results. If conducted under an Investigator’s IND, the academic researchers would be free to publish the study results as they see fit without interference from the Company.

To date, Cytolin^® has only been used in approximately 200 patients and it has not been used in human subjects for periods in excess of 18 months. Consequently, its long-term safety and efficacy have not been established. Clinical research entails many uncertainties and the results from large, multicenter clinical trials may differ substantially from the results obtained during preliminary clinical trials. Furthermore, if public health officials succeed in responding to the health crisis emerging in communities where HIV infection is on the rise by encouraging safe sex and by reducing the other risk factors for HIV and AIDS, then the potential market for Cytolin^® would be reduced.

Key words: HIV, AIDS, research drugs, diseases, health crisis, safe sex

This news release was approved by the Committee on Nominations and Corporate Governance of the Board of Directors of CytoDyn, Inc.

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