An Ontario-based cannabinoid researcher and developer has now entered into an agreement to supply its cannabis derivatives to one of the oldest medical schools in California.
On Tuesday, MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) announced that it had engaged in a research support agreement with the Keck School of Medicine at the University of Southern California.
The new research endeavour will involve a randomized double-blind placebo-controlled Phase 2 trial to determine the efficacy of THC and CBD for the treatment of hospice-eligible patients suffering from dementia and agitation.
NEWS: 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.https://t.co/j7xfwcC7F5 pic.twitter.com/AQiJ2bisO4
— MediPharm Labs (@MediPharmLabs) August 9, 2022
MediPharm Labs focuses on developing and manufacturing purified pharmaceutical-grade cannabis extracts and active pharmaceutical ingredients (APIs). The company is actively involved with the formulation, development, processing, packaging and distribution of cannabis concentrates and so-called advanced cannabinoid-based products.
The company was founded in 2015 and received a Pharmaceutical Drug Establishment License from Health Canada in 2021, rendering MediPharm the only North American company in possession of a domestic Good Manufacturing License for extracting organic cannabinoids.
Established in 1885, the Keck School of Medicine is the oldest medical institution in Southern California. The institute is home to 26 different research-oriented academic programs, has over 5,000 physician graduates practicing in the state and allegedly generates over US$230 million in annual sponsored research.
The new study will be led by the Alzheimer’s Clinical Trial Consortium (ACTC) and an assortment of experts. ACTC is an organization dedicated to the study of therapies for Alzheimer’s disease and related dementia.
MediPharm says that the lead investigators for the study have been awarded a US$16 million grant from the U.S. National Institutes of Health and the National Institute on Aging to support the new research project. MediPharm will also supply those leading investigators with the liquid oral cannabis study drug, placebo and consultation that may be needed throughout the course of the analysis.
According to MediPharm, people suffering from Alzheimer’s disease and dementia near the end of their lives are usually prescribed a combination of opiates, antipsychotics and sedatives. Those medications can often cause unwanted side effects that actually worsen the health of patients and add an even greater burden to those providing care to them.
MediPharm says research suggests that cannabis derivatives can effectively manage distress and agitation experienced by patients without the nasty complications often caused by those aforementioned prescription medications.
This new project is designed to assess the efficacy of an orally administered combination of CBD and THC for treating agitation in participants who have been diagnosed with dementia and who are eligible to receive hospice care. As stated by MediPharm, the proposed study will consist of a 12-week, Phase 2, multicenter, randomized, double-blind, parallel-group, placebo-controlled analysis intended to evaluate the tolerability and efficacy of a THC/CBD oral combo at week 2 and evaluate secondary outcomes at week 12.
Approximately 150 participants from 20 clinical trial sites in the U.S. will be recruited over the course of a two-year period, according to MediPharm.
“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,” said David Pidduck, CEO at MediPharm.
“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,” added Pidduck.