Oral entry HIV inhibitor enters trial

Samaritan Pharmaceuticals, a developer of innovative drugs, has officially initiated a Phase II double-blind, placebo controlled, multi-dose, monotherapy study in treatment-experience HIV patients.

The trial will assess SP01A's safety and effect on viral load in HIV-1 positive individuals, with evidence of increasing viral load despite treatment with other antiretroviral therapy.

Dr. Greeson, ceo of Samaritan Pharmaceuticals, said: 'our previous Phase II study showed SP01A to be safe and effective, and with our preclinical studies, it appeared to demonstrate an activity against multiple HIV strains. This encouraged us to explore it as having a new mechanism of action and as possibly the first oral entry inhibitor drug. Currently the only approved FDA entry inhibitor is taken by injection.'

The study will enroll a total of 92 patients in at least four groups. It is expected to start shortly and finish enrollment in September. The primary analysis for the study is the reduction in viral load (log10) in each of the SP01A active and placebo arms, as measured from baseline to study-end. Initial draft study results are expected to be available before the end of the year.

In collaboration with Georgetown University, Samaritan is currently working to advance its proprietary compounds for AIDS, Alzheimer's, Cancer and Cardiovascular disease.