DiagnosticsCytoDyn Completes Safety Testing Of Cytolin(R): Benchmark For Improved Treatment Of HIV/AIDS
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 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.
Cytolin®