- MediPharm to design, manufacture and supply a liquid oral
cannabis study drug for the Phase 2 Life's end Benefits
of cannabidiol and tetrahydrocannabinol (LiBBY)
study, to be conducted in the U.S., across 20 sites.
- The lead investigators have been awarded a total of
US$16M grant from the US National
Institutes of Health and the National Institute on Aging to support
the research project.
BARRIE,
ON, Aug. 9, 2022 /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 announce it has entered
into a research support agreement with the Keck School of Medicine
of University of Southern California
(USC) to conduct a randomized
double-blind placebo controlled Phase 2 trial on the efficacy of
THC and CBD to treat hospice-eligible patients diagnosed with
dementia and experiencing agitation.
The lead investigators are Jacobo
Mintzer, MD, MBA, Brigid
Reynolds, ANP-BC, and the Alzheimer's Clinical Trial
Consortium (ACTC).The ACTC is led by Paul
Aisen, MD, Alzheimer's Therapeutic Research Institute at the
USC, Ron
Petersen, MD, of Mayo Clinic, and Reisa Sperling, MD of the Brigham and Women's Hospital at Harvard Medical School. Consistent with MediPharm's
commitment to clinical research and the progression and adoption of
drugs containing cannabis, the Company will supply the Sponsor and
the Principal Investigators with the study drug and placebo, and
such other information and assistance as may be required during the
course of the study.
Management Commentary
David Pidduck, CEO, MediPharm
Labs commented, "We are proud to participate in this important
research that further solidifies our pharmaceutical approach to
medical cannabis. This trial benefits from passionate lead
investigators, a world-renowned sponsor institution and funding
from the US National Institute of Health. Dementia and related
indications are hard to treat for patients and caregivers
especially at the end-of-life stage. It is our hope that the study
will potentially provide a better therapeutic option than the
current standard of care. MediPharm has invested in the
infrastructure, licensing and expertise to become the preferred
partner for pharmaceutical companies looking to add drugs
containing cannabis to their pipelines. The [partnership] announced
this morning provides further evidence that the Company has
established processes that meet rigorous U.S. national and state
specific regulations, and set the foundation for similar
announcements in the future as we continue to build our
pipeline."
Study Details – provided by Alzheimer's Clinical Trial
Consortium
Approximately 50% of people diagnosed with Alzheimer's disease
or other types of dementia will receive hospice care at the end of
their life(1). Of these, more than 70% will be
prescribed psychiatric medications for management of
agitation(2). There are no approved treatments or
guidelines to assist clinicians in addressing end-of-life agitation
in dementia. In the absence of appropriate evidence-based
guidelines, patients are typically prescribed a combination of
antipsychotics, sedatives, and opiates. These medications often
lead to undesirable side effects, all of which tend to make the
situation even worse, lowering quality of life for patients, and
adding burden to their care partners.
Recent research suggests that derivatives of cannabis can be
beneficial in controlling agitation and distress without the side
effects of medications commonly used to treat agitation. In this
project, Keck School of Medicine has chosen to use a combination of
two medications, THC and CBD. This project aims to test the
efficacy of an oral combination of THC and CBD, for the treatment
of agitation in participants with a diagnosis of dementia who are
eligible for hospice and experiencing agitation. The proposed study
consists of a 12-week, Phase 2, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study,
with primary outcomes evaluating the efficacy and tolerability
of a THC/CBD oral combination at week 2 and secondary outcomes at
week 12.
The study will recruit approximately 150 participants from 20
clinical trial sites in the United
States over a two year period.
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
Establishment 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.
Website: www.medipharmlabs.com
(1) Reference: Alzheimer's Disease Facts and Figures, 2022
Annual Report, Alzheimer's Association
Reference: Gerlach LB, Fashaw S, Strominger J, Ogarek J, Zullo
AR, Daiello LA, Teno J, Shireman TI, Bynum JPW. Trends in
antipsychotic prescribing among long-term care residents receiving
hospice care. J Am Geriatr Soc. 2021 Aug;69(8):2152-2162.
(2) Reference: Liu CS, Chau SA, Ruthirakuhan M, Lanctôt KL,
Herrmann N. Cannabinoids for the Treatment of Agitation and
Aggression in Alzheimer's Disease. CNS Drugs. 2015
Aug;29(8):615-23.
Reference: Ruthirakuhan M, Lanctôt KL, Vieira D, Herrmann N.
Natural and Synthetic Cannabinoids for Agitation and Aggression in
Alzheimer's Disease: A Meta-Analysis. J Clin Psychiatry. 2019 Jan
29;80(2):18r12617.
Alzheimer's Clinical Trials Consortium (ACTC) is
funded by a Cooperative Agreement from the National Institute on
Aging, National Institutes of Health. Cooperative Agreement number
U24AG057437.
Life's End Benefits of Cannabidiol and
Tetrahydrocannabinol (LiBBY)
Pls: Jacobo Mintzer, MD,
MBA, Brigid Reynolds, NP
Duration: 4 years
NIA/NIH Grant #: R01 AG068324-01
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: exciting
opportunities ahead; the expected results of any clinical research,
the development of future cannabis derived pharmaceutical drugs,
being a low-capital avenue to research and future marketable
pharmaceutical products, and targeting further similar projects.
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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