Samaritan begins phase 3 trial of HIV oral entry inhibitor SP01A ahead of schedule

By Lisa Kerner

Charlotte, N.C., June 15 - Samaritan Pharmaceuticals Inc. said its subsidiary, Samaritan Europe, is accelerating the development of its lead HIV drug candidate, SP01A, by starting a late-stage phase 3 trial in Europe before the end of its ongoing phase 2, 28-day monotherapy study of SP-01A.

The double-blind, placebo controlled study will assess the safety and efficacy of SP01A on viral load in 411 HIV-positive treatment-experienced patients, according to a company news release.

Patients will be randomly assigned to receive a placebo or SP01A for 48 weeks. The primary endpoint will be the mean change in HIV RNA viral load after 24 weeks.

SP01A appears to have cytoprotective properties with a new mechanism of action, working within the cellular membrane and not directly on the HIV virus, officials said.

Las Vegas-based Samaritan discovers and develops therapeutics' designed to alleviate heart attacks, cancer, stroke, memory loss and AIDS.

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