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MediPharm Labs Enters Cannabis Research Agreement with Keck School of Medicine of USC

Chosen by Staff Editors on 09-AUG-22

BARRIE, ON (TDN) August 9, 2022
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.

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.

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

Related URL:https://www.medipharmlabs.com

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