CytoDyn to Meet with Quest Clinical Research to Finalize Phase II Strategy for Novel AIDS Drug
Following a management meeting in San Francisco on June 7, representatives of CytoDyn, Inc. (Pink Sheets: CYDY) will be meeting with Principle Investigator Dr. Jay Lalezari at Quest Clinical Research to finalize the Company’s strategy for a Phase II trial of Cytolin®. An immune therapy that uses the human immune system to control HIV infection, Cytolin® was used for two years before the antiretroviral cocktails became available to delay the progression of AIDS in about 200 patients, as reported by CBS-TV News.
Because the standard for treating HIV/AIDS is rapidly evolving, the Company must decide on the best indication to pursue prior to submitting a protocol to the FDA. On the one hand, patients failing Highly Active Antiretroviral Therapy (HAART) have an urgent need for treatment options. On the other hand, experts recognize a benefit to delaying initiation of antiretroviral therapy until medically necessary because starting treatment may mean a change in the patient’s lifestyle, some antiretroviral drugs have serious side effects, and resistance may develop, which limits future treatment options. Based on previous clinical experience, Cytolin® might also be used to control HIV infection delaying the need for antiretroviral therapy.
About Quest Clinical Research Quest Clinical Research provides clinical research dedicated to the development of new therapies for treating life-threatening viral illnesses, such as HIV/AIDS, Hepatitis B and C, CMV infection and influenza. It has provided access to investigational drugs to over 5,000 individuals throughout Northern California since 1989 at no cost to patients.
About Cytolin® HIV infects other species, such as chimpanzees. But only humans get sick from HIV infection. In the early 1990s, several teams of university-based scientists reported in the peer-review literature that this is because of a flaw in the human immune system. Cytolin®, a monoclonal antibody, is designed to correct that flaw. This is different from "reconstituting" the immune system, which can make patients sick ("immune reconstitution syndrome"). With the human immune system working better, we would expect it to do a better job of controlling HIV infection.
Disclaimer This press release contains forward-looking statements that are not historical facts but only reflect the Company’s estimates and projections. There are many factors, known and unknown, that could cause actual results to differ significantly. These factors include, but are not limited to, unanticipated problems and accidents during the manufacturing process, unexpected regulatory difficulties, unexpected difficulties with patient enrollment, unexpected study results, economic downturns, the effects of adverse publicity, litigation, competition, victimization by white-collar offenders, and other factors that may be identified from time to time in the Company's announcements.
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