- MediPharmto design, manufacture and supply a liquid oral cannabis study drug for thePhase 2 Life’s end Benefits of cannabidiol and tetrahydrocannabinol (LiBBY)study, to be conducted in the U.S., across 20 sites.
- Thelead investigators have been awarded a total of US$16M grant from the USNational Institutes of Health and the National Institute on Aging to supportthe research project.
BARRIE, August9, 2022 (CISION NEWSWIRE) -- MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF)(FSE: MLZ) (“MediPharm Labs” or the “Company”) a pharmaceutical companyspecialized in precision-based cannabinoids, is pleased to announce it hasentered into a research support agreement with the Keck School of Medicine of Universityof Southern California (USC) to conduct a randomized double-blind placebocontrolled Phase 2 trial on the efficacy of THC and CBD to treat hospice-eligiblepatients diagnosed with dementia andexperiencing agitation.
The leadinvestigators are Jacobo Mintzer, MD, MBA, Brigid Reynolds, ANP-BC, and theAlzheimer’s Clinical Trial Consortium (ACTC).The ACTC is led by Paul Aisen, MD,Alzheimer’s Therapeutic Research Institute at the USC, Ron Petersen, MD, ofMayo Clinic, and Reisa Sperling, MD of the Brigham and Women’s Hospital atHarvard Medical School. Consistent with MediPharm’s commitment to clinicalresearch and the progression and adoption of drugs containing cannabis, theCompany will supply the Sponsor and the Principal Investigators with the studydrug and placebo, and such other information and assistance as may be requiredduring the course of the study.
David Pidduck, CEO, MediPharm Labs commented, “We are proud to participatein this important research that further solidifies our pharmaceutical approachto medical cannabis. This trial benefits from passionate lead investigators, aworld-renowned sponsor institution and funding from the US National Instituteof Health. Dementia and related indications are hard to treat for patients andcaregivers especially at the end-of-life stage. It is our hope that the studywill potentially provide a better therapeutic option than the current standardof care. MediPharm has invested in theinfrastructure, licensing and expertise to become the preferred partner for pharmaceuticalcompanies looking to add drugs containing cannabis to their pipelines. The[partnership] announced this morning provides further evidence that the Companyhas established processes that meet rigorous U.S. national and state specificregulations, and set the foundation for similar announcements in the future aswe continue to build our pipeline.”
Study Details – providedby Alzheimer’s Clinical Trial Consortium
Approximately50% of people diagnosed with Alzheimer’s disease or other types of dementiawill receive hospice care at the end of their life(1). Of these, more than 70% will beprescribed psychiatric medications for management of agitation(2). There are noapproved treatments or guidelines to assist clinicians in addressing end-of-lifeagitation in dementia. In the absence of appropriate evidence-based guidelines,patients are typically prescribed a combination of antipsychotics, sedatives, and opiates. Thesemedications often lead to undesirable side effects, all of which tend to makethe situation even worse, lowering quality of life for patients, and addingburden to their care partners.
Recentresearch suggests that derivatives of cannabis can be beneficial in controllingagitation and distress without the side effects of medications commonly used totreat agitation. In this project, Keck School of Medicine has chosen to use acombination of two medications, THC and CBD. This project aims to test theefficacy of an oral combination of THC and CBD, for the treatment of agitationin participants with a diagnosis of dementia who are eligible for hospice andexperiencing agitation. The proposed study consists of a 12-week, Phase 2,multicenter, randomized, double-blind, parallel-group, placebo-controlledstudy, with primary outcomes evaluating the efficacy and tolerabilityof a THC/CBD oral combination at week 2 and secondary outcomes at week 12.
The studywill recruit approximately 150 participants from 20 clinical trial sites in theUnited States over a two year period.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the development andmanufacture of purified, pharmaceutical-quality cannabis concentrates, activepharmaceutical ingredients (API) and advanced derivative products utilizing aGood Manufacturing Practices certified facility with ISO standard-built cleanrooms. MediPharm Labs has invested in an expert, research driven team,state-of-the-art technology, downstream purification methodologies andpurpose-built facilities with five primary extraction lines for delivery ofpure, trusted and precision-dosed cannabis products for its customers. Throughits wholesale and white label platforms, MediPharm Labs formulates, develops(including through sensory testing), processes, packages and distributescannabis extracts and advanced cannabinoid-based products to domestic andinternational markets.
In 2021, MediPharm Labs received a Pharmaceutical Drug EstablishmentLicense from Health Canada, becoming the only company in North America to holda domestic Good Manufacturing License for the extraction of naturalcannabinoids. The Company carries out its operations in compliance with allapplicable laws in the countries in which it operates.
For further information, please contact:
MediPharm LabsInvestor Relations
Telephone: +1 416.913.7425 ext. 1525
(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-termcare residents receiving hospice care. J Am Geriatr Soc. 2021Aug;69(8):2152-2162.
(2) Reference:Liu CS, Chau SA, Ruthirakuhan M, Lanctôt KL, Herrmann N. Cannabinoids for theTreatment of Agitation and Aggression in Alzheimer's Disease. CNS Drugs. 2015Aug;29(8):615-23.
Reference: Ruthirakuhan M, Lanctôt KL,Vieira D, Herrmann N. Natural and Synthetic Cannabinoids for Agitation andAggression in Alzheimer's Disease: A Meta-Analysis. J Clin Psychiatry. 2019 Jan29;80(2):18r12617.
Alzheimer's ClinicalTrials 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 andTetrahydrocannabinol (LiBBY)
Pls: JacoboMintzer, MD, MBA, Brigid Reynolds, NP
Duration: 4 years
NIA/NIH Grant #: R01 AG068324-01
Cautionary NoteRegarding 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. Allstatements, other than statements of historical fact, are forward-lookingstatements and are based on expectations, estimates and projections as at thedate of this news release. Any statement that involves discussions with respectto predictions, expectations, beliefs, plans, projections, objectives,assumptions, future events or performance (often but not always using phrasessuch as “expects”, or “does not expect”, “is expected”, “anticipates” or “doesnot anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”,“believes” or “intends” or variations of such words and phrases or stating thatcertain 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 maybe forward-looking statements. In this news release, forward-looking statementsrelate to, among other things, statements regarding: exciting opportunitiesahead; the expected results of any clinical research, the development of futurecannabis derived pharmaceutical drugs, being a low-capital avenue to researchand future marketable pharmaceutical products, and targeting further similarprojects. Forward-looking statements are necessarily based upon a number ofestimates and assumptions that, while considered reasonable, are subject toknown and unknown risks, uncertainties, and other factors which may cause theactual results and future events to differ materially from those expressed orimplied by such forward-looking statements. Such factors include, but are notlimited to: general business, economic, competitive, political and socialuncertainties; the inability of MediPharm Labs to obtain adequate financing;the delay or failure to receive regulatory approvals; and other factorsdiscussed in MediPharm Labs’ filings, available on the SEDAR website atwww.sedar.com. There can be no assurance that such statements will prove to beaccurate, as actual results and future events could differ materially fromthose anticipated in such statements. Accordingly, readers should not placeundue reliance on the forward-looking statements and information contained inthis news release. Except as required by law, MediPharm Labs assumes noobligation to update the forward-looking statements of beliefs, opinions,projections, or other factors, should they change.