- MediPharm Labs shares progress on clinical trials, including
the provision of clinical trial materials and research support to
multiple partners.
- Research support consists of both product and services for
partner studies across various indications.
- MediPharm Labs participation ranges from full drug development
support to FDA approved clinical trial materials.
- MediPharm Labs GMP Drug Establishment License, DMF capability,
Natural Health Products licence and Cannabis Drug Licence in
addition to its FDA registered facility positions the Company with
unique capabilities to support trials globally including the
US.
TORONTO,
March 1,
2023 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS)
(OTCQX: MEDIF) (FSE: MLZ) ("MediPharm Labs" or the "Company") a
pharmaceutical company specialized in precision-based cannabinoids,
is pleased to provide an update on significant progress made in the
field of cannabis research.
MediPharm remains focused on investing in
clinical research and supporting the development of future cannabis
derived pharmaceutical drugs. Consistent with this commitment, the
Company will supply the Sponsor and investigators with
cannabis-derived study drugs, placebos, and other services and
assistance as may be required during the course of the
studies. The following update provides current milestone
achievements of notable projects.
Researcher
|
Indication
|
Phase
|
Recent
Milestone
|
USC (University of
Southern California) Keck School of Medicine
|
Treatment of
Alzheimer's Agitation Disorder
|
Two
|
FDA approval of
Investigational New Drug (IND)
|
McMaster
University
|
Treatment of
post-surgical pain
|
Two
|
Clinical trial material
(CTM) delivered and enrollment commencing in Q1 2023
|
University Health
Network - Toronto
|
Improving Pain
Disability With The Use Of Oral Cannabinoids
|
Pilot
|
CTM Delivered and
enrollment clinic in Q1 2023
|
McMaster
University
|
Insomnia in depressive
disorder
|
Two
|
CTM
Shipment in Q1 2023
|
Centre for Medical
Cannabis Research
|
PK of single dose
THC/CBD in healthy adult controls and kidney disease
|
One
|
1st patient
dosed January 2023
|
University of
Manitoba
|
Chronic Headaches in
Adolescents
|
Two
|
Health Canada approval
Dec 2022. CTM shipment in Q1 2023
|
In addition to these institutionally led studies, the Company is
also providing API and clinical trial material to various
pharmaceutical companies for commercial projects involving
cannabis-derived drugs. The timelines for both institutional and
industry research are long by nature with positive outcomes
uncertain.
MediPharm has been selected by these researchers
based on the US and Canadian Regulatory requirements for
pharmaceutical GMP manufactured clinical trial materials. MediPharm
is uniquely positioned as a Pharmaceutical grade supplier due to
its Health Canada GMP Drug Establishment Licence (DEL); Cannabis
Drug Licenses; US FDA DMF experience; and medical cannabis
formulations expertise. Since the company's founding, it has
invested tens of millions of dollars to establish itself as the
preferred partner for pharma companies looking to add drugs
containing cannabis to their pipelines. The Company expects to
support further clinical trials in the US, Canada and other countries. Success in
producing and delivering cannabis study drug in Canada and now approvals to supply US studies,
demonstrate that we have the pharmaceutical quality and regulatory
standards required to address complex US national and state
specific regulations.
With existing infrastructure and expertise
MediPharm will continue to invest in all aspects of the
pharmaceutical cannabis research spectrum, from new drug
development to early-stage academic research. The Company
looks forward to providing further updates on project milestones as
our research programs progress.
Management Commentary
David Pidduck,
CEO, MediPharm Labs commented, "Commitment to
pharmaceutical cannabis research has been a founding principle of
the company since its inception. It's in our name - that medical
and pharmaceutical insights will be core investment areas. We are
proud to participate in and support these many important research
and drug development initiatives with multiple Pharma and Academic
partners."
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.
In 2021, MediPharm Labs received a Pharmaceutical
Drug Establish License from Health Canada, becoming the only
company in North America to hold a
domestic Good Manufacturing License for the extraction of natural
cannabinoids. The Company carries out its operations in compliance
with all applicable laws in the countries in which it operates.
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, statements regarding: the expected results
of any clinical research, being a low-capital avenue to research
and future marketable pharmaceutical products, target further
similar projects, creating an opportunity for future patient and
physician education based on trial outcomes, expecting to support
further clinical trials in Canada
and other countries, continuing to scale its clinical trial support
business without the need for additional capital, and that medical
and pharmaceutical insights will be core investment areas in the
future. 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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SOURCE MediPharm Labs Corp.