HUMAN GENOME SCIENCES RECEIVES FDA CLEARANCE TO INITIATE CLINICAL DEVELOPMENT OF A NEW COMPOUND FOR THE TREATMENT OF HIV/AIDS

Human Genome Sciences has received clearance from the FDA for its investigational new drug application to begin clinical trials of CCR5 mAb for the treatment of HIV/AIDS.

CCR5 mAb (CCR5mAb004) is a fully human monoclonal antibody that specifically recognizes and binds the chemokine receptor CCR5. The CCR5 receptor is known to be a key facilitator of infection with HIV-1, the retrovirus that causes AIDS.

Human Genome Sciences plans to proceed with a Phase I clinical trial to evaluate the safety, tolerability and pharmacology of CCR5 mAb in patients who are infected with HIV-1. The Phase I trial will be a randomized, placebo-controlled, dose-escalation, multicenter study.

The primary objective of the study will be to evaluate the safety and tolerability of escalating doses of a single intravenous infusion of CCR5 mAb. The secondary objectives of the Phase I study will be to determine the pharmacokinetics of CCR5 mAb, and to assess its effect on plasma HIV-1 viral load and on CD4+ and CD8+ T-cell counts over time.