Orion Biotechnology announced that the Polish National Regulatory Agency and Local Ethics Committee have given approval for the OB-002H-101 Phase 1 safety and acceptability study of OB-002H gel to start screening and enrollment. The OB-002H gel is a topical formulation of OB-002 (5P12-RANTES), a novel chemokine analogue that binds to the CCR5 receptors in order to prevent HIV infection. OB-002 is best-in-class in terms of in vitro potency and has previously been shown to completely prevent SHIV infection in a non-human primate (NHP) model of HIV infection. The OB-002H-101 study will enroll 30 healthy volunteers who will receive either single or multiple vaginal or rectal doses of the gel product. The study will evaluate the safety, acceptability, and pharmacokinetic (PK) profile of the gel and will be conducted at a Phase 1 research unit in Warsaw, Poland. Preliminary data from the study are anticipated in Q2 2020.
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