Insomnia Treatment Study using MediPharm Labs CBD50 Product to Proceed to Phase 2 with Health Canada Consent
2021年8月31日 - 8:00PM
MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF)
(FSE: MLZ) (“MediPharm Labs” or the “Company”) a pharmaceutical
company specialized in cannabis, is pleased to announce that the
Company’s research partner McMaster University (the “Researcher”)
has received a no objection letter from Health Canada to proceed
with research with MediPharm Labs CBD50 and CBD10:2. This is a key
milestone in moving forward with the Company’s strategy to be the
go-to cannabis partner for pharmaceuticals containing cannabis.
This phase 2 trial is a pilot, double-blind,
randomized, placebo-controlled trial that will be evaluating the
efficacy and safety of a cannabis-oil for the treatment of insomnia
in major depressive disorder. The study is being conducted by a
clinical research group led by Dr. Benicio Frey, Professor,
McMaster University and Psychiatrist, St. Joseph’s Healthcare
Hamilton. As North America has made progress in diagnosing and
eliminating the stigma around mental health, more patients are
looking for therapeutic treatment options.
The Researchers believe that cannabidiol (“CBD”)
with or without THC could be effective in the treatment of sleep
disorders related to depression. In order to prove this efficacy, a
high quality, dosable and standardize formulation is needed for
clinical trial material. MediPharm Labs will use its Cannabis Drug
Licence and Drug Establishment Licence to provide access to
clinical trial material that meets these pharmaceutical quality
standards and Good Manufacturing Practices (“GMP”), as well as
provide investigative protocol and regulatory approval support.
“As a pharmaceutical company specialized in
cannabis, MediPharm Labs is encouraged by the ongoing research and
development of drugs containing cannabis. This study will create
opportunities to show efficacy in our already commercialized
cannabis oil while also making progress on our long-term goal to
manufacture pharmaceutical drugs containing cannabinoids as an
active ingredient,” said Keith Strachan, President and Interim CEO,
MediPharm Labs.
“Many individuals around the world are using
cannabinoids to treat their sleep problems without robust clinical
evidence from placebo-controlled trials. This study is, therefore,
a major step towards evidence-based research investigating the
efficacy and safety of CBD and CBD/THC in the treatment of insomnia
in those who suffer from depression,” said Dr. Benicio Frey.
The is the second approval of its kind for a
clinical trial with McMaster. A trial lead by a separate clinician
group received a letter of no objection in June 2021 to proceed
with using MediPharm Labs CBD50 for a randomized trial studying the
effect of cannabidiol vs. placebo on persistent post-surgical pain
following total knee arthroplasty.
The Company looks forward to progressing both
these active trials with the respective researchers while using its
GMP Drug Establishment License and Health Canada Cannabis Drug
License to supply API and finished goods to others development
pharmaceutical drugs with marketing authorization.
About MediPharm Labs
Founded in 2015, MediPharm Labs is a
pharmaceutical company that specializes in the development and
manufacture of purified, pharmaceutical-quality cannabis
concentrates, active pharmaceutical ingredients 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 four 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 clinical
trials as planned; being the go-to cannabis partner for
pharmaceuticals containing cannabis; the creation of opportunities
to show efficacy in the Company’s already commercialized cannabis
oil; progress on the Company’s long-term goal to manufacture
pharmaceutical drugs containing cannabinoids as an active
ingredient; and the development of pharmaceutical drugs containing
cannabis. 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.
For further information, please contact:
MediPharm Labs Investor Relations
Telephone: +1 416.913.7425 ext. 1525
Email: investors@medipharmlabs.com
Website: www.medipharmlabs.com
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