January 29, 2019

Orion Biotechnology Canada report that IND- enabling studies evaluating the safety of their OB-002H microbicide gel have shown an excellent mucosal safety profile

OTTAWA, Jan. 29, 2019 (GLOBE NEWSWIRE) — Orion Biotechnology Canada Ltd., a developer of novel medical treatments, today announced preclinical data evaluating the safety of OB-002H (5P12-RANTES) which is being developed as a topical microbicide for HIV prevention. We have previously shown that 5P12- RANTES was able to completely prevent SHIV infection in a rhesus macaque model (Veazey R et al. Journal of Infectious Diseases 2009) and we are now finalizing preclinical evaluation of OB-002H to support future Phase 1 studies. Fourteen day repeat vaginal and rectal dosing good laboratory practice (GLP) studies were conducted in rodents and rabbits by Calvert Laboratories. Animals received daily vaginal or rectal administration of OB-002H gel, matched placebo, or a sham challenge for fourteen days.  The animals were evaluated for safety throughout the study and upon completion histopathological examination of vaginal and rectal tissue was undertaken to determine whether repeated topical administration of OB-002H gel was associated with mucosal irritation or inflammation.  A composite irritation score was used where a score of 0/16 was normal and 12-16 reflected severe mucosal irritation/inflammation (ISO 10993-10; 2010). There were no significant safety findings in the study and the mucosal irritation scores across the four studies were 0/16 for each study.

“Despite increasing access to oral PrEP there remains an unmet need for safe and effective topical products that can be used in a pericoital fashion. Based on our previous macaque studies, OB-002H is an extremely potent microbicide and with these GLP studies we now know that it has an excellent mucosal safety profile. With these new data, we plan to submit a regulatory  filing in Q1 2019 to support initiation of a Phase 1 study in Q3 2019,” said Dr. Ian McGowan, Chief Scientific Officer for Orion Biotechnology.

Mark Groper, President and CEO of Orion Biotechnology added, “We are delighted by these excellent preclinical mucosal safety data and look forward to moving our OB-002H gel into the clinic as quickly as possible.”

This post is also available in: Polski (Polish)

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