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.