( otects them from viral infection. HIV i...)Progenics Announces Positive Results in Clinical Trial of Novel HIV,Therapy,Health

otects them from viral infection. HIV in the bloodstream that cannot enter a host cell is rendered harmless and rapidly cleared from the body. In contrast to PRO 140's mechanism of action as a viral-entry inhibitor, most antiretroviral drugs are designed to slow viral replication inside already-infected immune cells.

Clinical trial design and study results

This multi-center, double-blind, randomized, placebo-controlled phase 1b trial examined three single intravenous escalating doses of PRO 140: 0.5 mg/kg, 2.0 mg/kg and 5.0 mg/kg. The study was designed to assess the safety, tolerability, pharmacology and antiviral activity of PRO 140 and was conducted at 10 sites in the United States. Thirty-nine HIV-infected individuals who had taken no anti-retroviral therapy within the preceding three months and who had plasma HIV RNA levels (viral loads) greater than or equal to 5,000 copies/mL were enrolled to receive PRO 140 monotherapy or placebo. All patients were screened prior to the study for the presence of virus that utilizes only CCR5 as the entry coreceptor. Of the 13 patients in each cohort, 10 patients received PRO 140 and three received placebo.

The primary efficacy endpoint was the reduction in plasma HIV RNA level as measured by the Roche Amplicor assay. The results were positive, dose-dependent, and highly statistically significant for the two highest doses tested. HIV-infected individuals who received 5.0 mg/kg of PRO 140 achieved an average maximum decrease of viral load of 1.83 log10 (98.5%; p<0.0001), with individual reductions ranging up to 2.5 log10 (99.7%). At nine days post-treatment, these same individuals achieved a mean viral load reduction of 1.70 log10 (98%; p<0.0001). In this cohort, mean viral load was suppressed by 1.0 log10 (90%) within four days of dosing and persisted at or below the 1.0 log10 level of reduction for two to three weeks in patients before returning to baseline at approximately 30 days. The response rate amo
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