HGS ANNOUNCES RESULTS OF HIV TREATMENT STUDY

Human Genome Sciences (HGS) has announced that the results of a Phase I clinical trial of HGS004 (CCR5 mAb) demonstrate that it was well-tolerated and exhibited antiviral activity in patients who are infected with HIV-1.

The Phase 1 trial was a randomized, placebo-controlled, dose-escalation, multicenter study in patients who were infected with HIV-1 and not receiving concurrent antiretroviral therapy. The primary objective was to evaluate the safety and tolerability of escalating doses of a single intravenous (IV) infusion of HGS004. The secondary objectives were to determine the pharmacokinetics of HGS004, and to assess its effect on plasma HIV-1 viral load and on CD4+ and CD8+ T-cell counts over time. Patients were followed for 56 days after study agent administration.

A total of 54 patients were randomized and enrolled into six dose cohorts at a ratio of 4:1 (active: placebo). In each cohort, patients received a single IV infusion of HGS004 or matching placebo (0.4 mg/kg, 2 mg/kg, 8 mg/kg, 20 mg/kg, and 40 mg/kg). The results demonstrate that HGS004 was well-tolerated following administration of a single IV dose up to 40 mg/kg. A significantly higher antiviral response was observed in patients receiving HGS004 at doses of 8 mg/kg or greater. At these doses, a dose response was observed in viral load reduction at day 14.

HGS004 is a fully human monoclonal antibody that specifically recognizes and binds the chemokine receptor CCR5, which is known to be a key facilitator of infection with HIV-1. HGS004 was generated by HGS using the Abgenix XenoMouse technology.