RAMAT GAN, Israel, Jan. 30, 2019 /PRNewswire/ -- OWC Pharmaceutical Research Corp. (OWCP), a developer of cannabinoid-based therapies targeting a variety of different medical conditions and disorders, today 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.
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.
Mordechai Bignitz, Chief Executive Officer, stated, "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."
About OWC Pharmaceutical Research Corp
OWC Pharmaceutical Research Corp., through its wholly-owned Israeli subsidiary, One World Cannabis Ltd., (collectively 'OWC' or the 'Company') conducts medical research and clinical trials to develop cannabis-based pharmaceuticals and treatments for conditions including multiple myeloma, psoriasis, fibromyalgia, PTSD, and migraines.
OWCP is also developing unique and effective delivery systems and dosage forms of medical cannabis. All OWC research is conducted at leading Israeli hospitals and scientific institutions and led by internationally renowned investigators.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release, which are not purely historical, are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, filing patent applications, product development, and business strategy. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in OWC Pharmaceutical Research Corp. (OWCP) periodic reports filed from time-to-time with the Securities and Exchange Commission.
Mordechai Bignitz, Chief Executive Officer
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