CytoDyn files new IND for Cytolin

Oct 22 2008

CytoDyn, Inc. has filed a new IND for a study to reconfirm dose ranging and to "prove the principle" with a randomized, double-blind placebo controlled study of Cytolin, the Company's first-in-class drug for treating HIV/AIDS. This comes 13 years after the first IND was issued for the drug.

Initially, Cytolin® was used experimentally by community physicians to rescue 200 - 300 AIDS patients over a period of two years before the antiretroviral cocktails had become available, as reported by CBS-TV News. Subsequently, the drug's inventor and his associates learned the pitfalls of out-licensing technology in an environment where innumeracy created a fertile field for unfettered corporate malfeasance. The new study, the first to be sponsored by the drug's developers, will reconfirm dose ranging and will use the gold standard of the randomized, double-blind, placebo controlled trail to eliminate the need for the industry and public health officials to become familiar with a decade of progress in immunology.

The current need for Cytolin® arises because of natural selection, which has caused HIV to mutate to multi-drug resistant strains. The Financial Times, for example, recently reported that 30 out of 100 HIV-infected people in the Democratic Republic of the Congo carried strains of HIV that were resistant to the standard AIDS drugs they were being given. Cytolin® does not promote mutation of HIV to drug resistant strains, and treats all species of the virus, because it helps the human immune system re-establish control over the infection instead of attacking the virus directly. When first infected with HIV, a person's immune system controls the virus for several years or even a decade or more before losing control of the infection. In discovering why other species of primates can carry HIV infection without becoming ill, three researchers working independently discovered why the human immune system uniquely loses control of HIV infection. This research, published in the early 1990s, was conducted by Joyce Zarling, Leonard Adelman, and Allen D. Allen, CytoDyn's CEO. Cytolin® compensates for this unique trait of human immunity to help the immune system reassert control over the infection.

The Company has no estimate of how long it will take the FDA to review the Company's application. Other factors that can delay successful completion of a study's benchmarks are available on the Company's web site. This press release contains forward-looking statements that are not historical facts. CytoDyn'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 projections and involve a number of risks and uncertainties, including but not limited to, the failure of preliminary results from clinical studies to reflect the results from more comprehensive studies. 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 the factors that could cause actual results to differ materially from those estimated by CytoDyn. 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.