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.
For further information, please
contact:Laura Lepore, VP, Investor RelationsTelephone: +1
416.913.7425 ext.
1525Email: investors@medipharmlabs.comWebsite: www.medipharmlabs.com
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.
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