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OWC Pharmaceutical Research Corp, (OWCP), thorough its Israeli based fully owned subsidiary, a developer of cannabinoid-based therapies targeting a variety of different medical conditions and disorders, announced it is submitting the final Psoriasis IRB safety protocol for the Israeli national IRB committee at the Health Minister office.
The IRB protocol was first approved by the hospital which will perform the safety study and after obtaining its approval the IRB protocol is being submitted for approval to the national IRB committee. The national IRB committee is scheduled to ensemble at the beginning of December 2016.
Upon the expected approval of the safety protocol by the national committee, the company will immediately engage with the study which will last approximately 12 weeks.
Results are expected by the end of March 2016 and upon reaching satisfactory results the company intends to start production, marketing and sales in the US and EU in parallel to local IL efforts.
The Safety study is designed to test multiple escalating doses to determine the safety and tolerability of the medical grade cannabis cream on healthy volunteers. The psoriasis topical crème infused with active cannabinoids is a unique delivery-system product of OWC designed to be used for skin diseases, where the first application will be tested for safety and efficacy for Psoriasis. The efficacy studies have already been started and results are expected by the end of January 2017.
Psoriasis is an autoimmune disease that causes red, scaly patches to appear on the skin, and can be associated with other serious health conditions, including diabetes, heart disease and depression. The World Health Organization's 2016 Global Report on Psoriasis states that psoriasis is a serious global problem affecting at least 100 million individuals worldwide with estimated 8 million patients in the US. The report indicates the prevalence of psoriasis ranges from 0.09% in countries with warmer climates to 11.43% in Norway, where a colder climate prevails. The European market for psoriasis is estimated to be 15-20 million patients.
Dr. Yehuda Baruch, the company's CSO & director of Research and Regulatory Affairs said, "Best to my knowledge this is the first Cannabis safety study that was submitted to the Israeli IRB national committee to be performed on healthy volunteers. I am also not aware of any other cannabis infused topical crème that was tested for safety, efficacy and bio-availability with approved IRB. That makes our products unique and valuable which matches exactly the company's vision and targets to develop approved, safe and effective active-cannabinoids products for medical treatments."
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