OTTAWA, Ontario, Sept. 12, 2019 /PRNewswire/ — Orion Biotechnology Canada Ltd. today 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 (Veazey R et al. Journal of Infectious Diseases 2009). 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.
“Orion Biotechnology is very excited to move our OB-002H gel into the clinic,” said Dr. Ian McGowan, Chief Medical Officer for Orion Biotechnology. “Despite increasing access to oral pre-exposure prophylaxis with Truvada®, we believe there is an important role for HIV prevention products that can be used in a pericoital fashion.”
Mark Groper, President and CEO of Orion Biotechnology added; “It is unacceptable that we are still seeing 1.8 million new HIV infections each year and there is a compelling need to expand the HIV prevention portfolio so that men and women have more options to protect themselves from HIV infection. OB-002 has been shown to be safe and 100% protective in an NHP challenge model which makes it an ideal microbicide candidate.”
Professor Gita Ramjee from the Aurum Institute, Johannesburg, South Africa and a member of the OB-002H-101 Safety Monitoring Committee commented; “Young women in South Africa need more HIV prevention options and I look forward to working with the team at Orion Biotechnology to evaluate results from their Phase 1 study of the OB-002H gel.”