CytoDyn begins GMP production of AIDS drug

Los Angeles, USA-based CytoDyn says it has begun Good Manufacturing Practice-standard production and humanization of Cytolin, a monoclonal antibody that uses the human immune system to control HIV infection. The murine version of this product, for which there is already considerable human experience, will be used for a fast, randomized, double-blind, placebo-controlled clinical trial to supplement the data from a previous Phase Ib/IIa study. Ordinarily, pristine proof-of-principle requires a Phase III study. However, in the case of HIV/AIDS, a significant reduction in viral burden is universally accepted as a surrogate marker that reliably predicts reduced morbidity and increased life expectancy.

The human subjects who will be enrolled in the company's upcoming clinical trial will be adults with HIV infection who have significant viral burdens because they are not yet candidates for, or have declined, antiretroviral drugs. This eliminates the confounding factor of having patients who are taking a variety of other drugs. Jacob Lalezari, a prominent clinical researcher, will be the principal investigator for the study to be conducted in San Francisco, California. CytoDyn says it is aiming to have the study completed before the end of 2008, although noting that such timelines can never be guaranteed.