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news.Las Vegas-based biotech Samaritan Pharmaceuticals is starting a second phase II monotherapy trial of its lead anti-viral agent SP01A in treatment experienced HIV-infected patients.
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The company has completed patient enrollment in its first monotherapy trial and has now started this second trial to evaluate the oral entry inhibitor SP01A in what company representatives called an important milestone in the development of the compound.
The trial is a multi-center, double-blind, randomized, placebo-controlled, study of orally administered SP01A as monotherapy, in HIV-infected patients. The study is designed to accrue treatment-experienced HIV patients that are failing on their current anti-viral therapy.
Patients will be entered into a two-week washout phase followed by 28 days of monotherapy treatment with SP01A. The primary analysis for the study is the reduction in viral load (log10) in SP01A active arms and a placebo arm, as measured from baseline to the study end.
Dr Janet Greeson, CEO of Samaritan said: “We remain enthusiastically confident in the promise of SP01A. As we successfully complete each of these FDA milestones, it completely strengthens our belief in SP01A as a life-saving drug for HIV drug resistant patients.”