Human Genome Sciences Begins Dosing of Patients in Trial of CCR5 mAb
Human Genome Sciences has begun dosing patients in a Phase I clinical trial to evaluate the safety, tolerability and pharmacology of CCR5 mAb in patients who are infected with HIV-1, the retrovirus that causes 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 Phase I trial of CCR5 mAb is a randomized, placebo-controlled, dose-escalation, multicenter study in HIV-1 patients who are infected with HIV-1 and are not receiving concurrent antiretroviral therapy.
The primary objective is to evaluate the safety and tolerability of escalating doses of a single intravenous infusion of CCR5 mAb. The secondary objectives are 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.