CytoDyn has filed a new investigational new drug application 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 drug for treating HIV/AIDS.


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 trial to eliminate the need for the industry and public health officials to become familiar with a decade of progress in immunology.

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. The current need for Cytolin arises because of natural selection, which has caused HIV to mutate to multi-drug resistant strains, the company said.