TORONTO, Oct. 31, 2018 /CNW/ - FSD Pharma Inc. ("FSD Pharma" or "FSD") (CSE: HUGE) (OTCQB: FSDDF) (FRA: 0K9) today announced the launch of a pilot clinical study in Pittsburgh, Pennsylvania, by its strategic R&D partner, SciCann Therapeutics ("SciCann"). The study is designed to test the safety and efficacy of SciCann's proprietary "Steady Stomach" cannabidiol (CBD) combination product for the treatment of irritable bowel syndrome (IBS) patients. This study follows the previously reported efficacy results from a preclinical study in rodent models which demonstrated a three-fold increased efficacy in lowering abdominal inflammation levels with the advanced combination product as compared to CBD alone.
The double-blind, randomized, placebo-controlled study will enroll 20 patients in a cross-over design to comply with the highest standards of rigorous scientific validity and certification demands of international medical regulatory authorities.
Under the terms of FSD's strategic agreement with SciCann, the Company holds exclusive manufacturing and distribution rights for the "Steady Stomach" product in Canada.
The study's principal investigator is Dr. Bryan Doner of Compassionate Care Certifications Centers in Pittsburgh, Pennsylvania and the CRO is Affinity Bio Partners, led by CEO Dr. Christina DiArcangelo Puller.
Dr. Raza Bokhari, CEO of FSD Pharma, stated, "This innovative clinical study aims to demonstrate the safety and efficacy of this easy-to-administer, side-effect-free therapy for a very common disease. Although rarely spoken about, IBS causes suffering to many patients around the world by dramatically reducing quality of life. The launch of this study marks another important milestone for FSD on its way to becoming a leading supplier of superior and differentiated medical, cannabis-based therapies for patients. Together with our partner SciCann, FSD is working tirelessly towards the development of novel and disruptive cannabinoid-based therapies for the world's most under-treated diseases and irritable bowel syndrome is high on our list of target indications."
Dr. Zohar Koren, co-founder and CEO of SciCann Therapeutics, stated, "The prevalence of irritable bowel syndrome is estimated at 10-15 percent of the global population. This is an under-diagnosed, hard-to-treat condition that causes an estimated cost to society of over US$21 billion annually in direct medical expenses and indirect costs associated with loss of productivity1. Based on our research, we believe that our proprietary "Steady Stomach" CBD combination product can serve as a new treatment standard to improve the lives of patients. We are looking forward to reporting on the results of this clinical study. "
About FSD Pharma (CSE: HUGE) (OTCQB: FSDDF) (FRA: 0K9)
FSD Pharma is focused on the development of the highest quality indoor grown, pharmaceutical grade cannabis and on the research and development of novel cannabinoid-based treatments for several central nervous system disorders, including chronic pain, fibromyalgia and irritable bowel syndrome. The Company's phase one growth plan involves the development of 25,000 square feet of indoor grow space at its Ontario facility and an additional 220,000 square feet, which pending approval by Health Canada, is expected to be operational in the first quarter 2019.
FSD facilities sit on 72 acres of land with 40 acres primed for development and an expansion capability of up to 3,896,000 square feet.
FSD's wholly-owned subsidiary, FV Pharma, is a licensed producer of cannabis having received its cultivation license under the Access to Cannabis for Medical Purposes Regulations (ACMPR) on October 13, 2017 and is now operating under the recently enacted Cannabis Act. FV Pharma vision is to transform its current headquarters in a Kraft plant in Cobourg, Ontario into the largest hydroponic indoor grow facility in the world. FV Pharma intends to cover all aspects of this exciting, new industry, including cultivation, legal, processing, manufacturing, extracts and research and development.
About SciCann Therapeutics
SciCann Therapeutics is a Canadian-Israeli specialty pharmaceutical company, dedicated to the development and commercialization of novel and disruptive pharmaceutical products that target and modulate the endocannabinoid system. SciCann Therapeutics is active in the fields of oncology, pain management, neurodegenerative diseases and inflammatory disorders, and develops a line of proprietary products for the treatment of life-threatening conditions that present a high level of unmet need.
SciCann has created a network of collaborations with leading academic centers and medical institutions in Israel to engage in cutting edge science and rigorous clinical studies to develop its products, while using the permissive regulatory climate in Israel for performing its R&D programs quickly and efficiently.
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Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Corporation's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the development of the Corporation's indoor cannabis facility and its business goals and objectives. The forward-looking information contained in this press release is made as of the date hereof, and the Corporation is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward looking-information. The foregoing statements expressly qualify any forward-looking information contained herein.
SOURCE FSD Pharma Inc.
For further information: ON BEHALF OF FSD PHARMA: Zeeshan Saeed, President and Founder, FSD Pharma Inc., Email: [email protected], Telephone: (416) 854-8884; Investor Relations: Email: [email protected], Website: www.fsdpharma.com; Media Relations: Ned Berkowitz, Email: [email protected], Tel: (646) 942-5629; ON BEHALF OF SCICANN: Dr. Zohar Koren, Chief Executive Officer, Email: [email protected], Cell: +972-52-733-1424