MediPharm Labs Corp., (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in specialized, research-driven pharmaceutical-quality cannabis extraction, distillation and derivative products, is pleased to announce its wholly-owned subsidiary, MediPharm Labs Inc., has initiated a clinical trial to research and evaluate the effectiveness of MediPharm Labs’ proprietary cannabis-derived medical products and formulations on the treatment of end-stage renal disease or Chronic Kidney Disease (“CKD”), a leading and fast-growing cause of death worldwide.
MediPharm Labs has chosen to partner with Canadian firm, OTT Healthcare Inc. (“OTT”) and signed a Master Clinical Studies Agreement (the “Agreement”). As the expert principal investigator, OTT will study the pharmacokinetic (dosing) and safety profile of cannabinoid formulations for the Chronic Kidney Disease patient population and assess pain and Quality of Life (“QOL”) scores of patients receiving MediPharm Labs proprietary product formulations. Data gathered will support follow-on randomized double-blind clinical trials to establish the safety and efficacy of these products. Results of these activities including all intellectual property (“IP”) and inventions will be owned by MediPharm Labs.
“This Agreement is very meaningful for MediPharm Labs as it signals our dedication, as a specialized pharmaceutical company, to sponsoring and directly participating in the intense and ongoing scientific research necessary to bring the benefits of medical cannabis to those in dire need worldwide,” said Pat McCutcheon, CEO of MediPharm Labs. “The particular area of focus for this very significant Agreement is vitally important. Renal disease is the 11th leading and 6th fastest-growing cause of death globally and those with it suffer from pain, pruritus (severe skin itch), impaired sleep, depression and fatigue. We believe deep research into the use of medical cannabis to treat the effects of this devastating condition is long overdue.”
According to the Canadian Journal of Kidney Health and Disease, physical and psychological symptom burden in patients with advanced CKD is significantly debilitating; yet, it is often inadequately treated. Additionally, patients with CKD have limited life expectancy (estimated residual life span is approximately 8 to 4.5 years after dialysis initiation for those aged 40 to 64 years, respectively. Consequently, optimizing quality of life is of high priority. While patients may look to medical cannabis use in symptom management (including common symptoms encountered in advanced stages of CKD such as chronic pain, nausea and vomiting, anorexia, pruritus, and insomnia), its indications and long-term adverse health impacts are poorly established, creating a challenge for clinicians to support its use.
MediPharm Labs and OTT Healthcare will co-develop the study drugs that will be evaluated and name each Principal Investigator physician. The Principal Investigators will be accountable to MediPharm Labs for the direction of each study and will be chosen because of their leadership in the field of Nephrology. Before each study begins, all necessary approvals from relevant regulatory authorities including Health Canada will be obtained.
By providing tangible evidence of the benefits of medical cannabis, clinical trials of this nature set the stage for the development of safe, effective pharmaceutical-grade products.
“MediPharm Labs has established itself as a producer of pharmaceutical quality cannabis API and formulations. With our capabilities and research and development team, we are well positioned to support these trials and provide novel formulations including products from our portfolio and in general to expand our contribution to Nephrology,” said Mr. McCutcheon. “In broader terms, initiating this clinical trial demonstrates our growing maturity as a research-driven pharmaceutically focused company with global aspirations.”
MediPharm Labs is contributing to the advancement of medical cannabis in a variety of ways. In July 2020, it joined in a ground-breaking collaboration between University Health Network (“UHN”) and Medical Cannabis by Shoppers Inc. that will use blockchain technology to track medical cannabis products from seed to sale. In late 2019, it received its Cannabis Research Licence under Health Canada’s Cannabis Act and Cannabis Regulations to conduct controlled human administration trials of dried cannabis, cannabis extracts and concentrates, distillates, oil, edibles, topicals and terpenes at its state-of-the-art production facilities.
KIDNEY DISEASE FACTS
According to the National Kidney Foundation chronic kidney disease, or CKD, causes more deaths than breast cancer or prostate cancer. It is the under-recognized public health crisis. It affects an estimated 37 million people in the U.S. (15% of the adult population; more than 1 in 7 adults) and approximately 90% of those with CKD don’t even know they have it. 1 in 3 American adults (approximately 80 million people) is at risk for CKD. CKD is more common in women (15%) than men (12%). CKD is the 9th leading cause of death in the U.S. In 2017, over 500,000 patients received dialysis treatment, and over 200,000 lived with a kidney transplant.
Worldwide, approximately 1 in 10 people have kidney disease. One in three people in the general population is at increased risk of CKD. Global estimates indicate that 9 in 10 of those with CKD and are unaware of their condition. An estimated 1 million people die each year from untreated kidney failure. Those with CKD are up to 20 times more likely to die of other causes (mostly cardiovascular disease) before they reach end-stage renal disease.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. As a global leader, MediPharm Labs has completed commercial exports to Australia and completed commercialization of its Australian extraction facility which generated its first revenues in H1 2020. MediPharm Labs Australia was established in 2017.
Cautionary Note Regarding Forward-Looking Information:
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, the successful performance of the Agreement; the production of IP and inventions; the use of cannabis to treat CKD; the receipt of all required regulatory approvals; and the Company expanding its contribution to Nephrology. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.