OWC Pharmaceutical Research reported positive Phase 1 safety data for its medical grade cannabis MSG ointment for the treatment of skin diseases. No severe adverse events were observed in the trial. The Company is on track to initiate a Phase 2 trial of MSG ointment for the treatment of psoriasis during the third quarter 2019.
This Phase 1 trial was a single center, prospective, placebo-controlled, study to assess the safety and tolerability of topical MGC ointment (3% CBD, 3% THC) in healthy subjects. The study was conducted at Sheba Academic Medical Center in Israel between September 2017 when the first subject entered the study and January 2019 when the last subjected completed the study.
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The Study was divided into two stages:
Stage I was designed to evaluate the safety and tolerability following a single dose application of MGC ointment in 26 healthy volunteers. Subjects were hospitalized and monitored for 24 hours. Stage 2 was designed to assess the safety and tolerability of repeated applications of MGC topical ointment in healthy volunteers over a six week period. A total of 20 healthy subjects (13 subjects that participated in stage I and 7 newly recruited subjects) participated in this stage. MSG ointment treatment was applied by the subjects themselves, at home, twice daily. Subjects were asked to apply MGC ointment (daily dose of 30 mg CBD: 30 mg THC) on one arm and a placebo ointment (vehicle only) on the other arm. Investigators were blinded as to the type of treatment that was applied to each arm.
No severe adverse events were observed in either stages of the study. Minor irritation was observed in one subject.
"We are encouraged by the positive results from this Phase 1 safety trials. This was the first trial to assess the safety and tolerability of medical grade cannabis ointment as a topical treatment for skin diseases. We plan to commence a Phase 2 trial with MSC ointment for the treatment of psoriasis in the third quarter 2019," Mordechai Bignitz, Chief Executive Officer, said.