Pharmaceutical Business review

CytoDyn files new IND application for HIV drug

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.