MediPharm Labs Enters Hashish Analysis Settlement with Keck Faculty of Medication of USC

MediPharm Labs Enters Hashish Analysis Settlement with Keck Faculty of Medication of USC
  • MediPharm to design, manufacture and provide a liquid oral hashish research drug for the Section 2 Life’s finish Advantages of cannabidiol and tetrahydrocannabinol (LiBBY) research, to be carried out within the U.S., throughout 20 websites.

  • The lead investigators have been awarded a complete of US$16M grant from the US Nationwide Institutes of Well being and the Nationwide Institute on Growing older to help the analysis challenge.

BARRIE, ON, Aug. 9, 2022 /CNW/ – MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Firm”) a pharmaceutical firm specialised in precision-based cannabinoids, is happy to announce it has entered right into a analysis help settlement with the Keck Faculty of Medication of College of Southern California (USC) to conduct a randomized double-blind placebo managed Section 2 trial on the efficacy of THC and CBD to deal with hospice-eligible sufferers recognized with dementia and experiencing agitation.

MediPharm Labs Enters Hashish Analysis Settlement with Keck Faculty of Medication of USC

MediPharm Labs Corp. Emblem (CNW Group/MediPharm Labs Corp.)

The lead investigators are Jacobo Mintzer, MD, MBA, Brigid Reynolds, ANP-BC, and the Alzheimer’s Scientific Trial Consortium (ACTC).The ACTC is led by Paul Aisen, MD, Alzheimer’s Therapeutic Analysis Institute on the USC, Ron Petersen, MD, of Mayo Clinic, and Reisa Sperling, MD of the Brigham and Ladies’s Hospital at Harvard Medical Faculty. In keeping with MediPharm’s dedication to medical analysis and the development and adoption of medicine containing hashish, the Firm will provide the Sponsor and the Principal Investigators with the research drug and placebo, and such different info and help as could also be required through the course of the research.

Administration Commentary

David Pidduck, CEO, MediPharm Labs commented, “We’re proud to take part on this essential analysis that additional solidifies our pharmaceutical strategy to medical hashish. This trial advantages from passionate lead investigators, a world-renowned sponsor establishment and funding from the US Nationwide Institute of Well being. Dementia and associated indications are laborious to deal with for sufferers and caregivers particularly on the end-of-life stage. It’s our hope that the research will probably present a greater therapeutic possibility than the present normal of care. MediPharm has invested within the infrastructure, licensing and experience to grow to be the popular companion for pharmaceutical firms wanting so as to add medicine containing hashish to their pipelines. The [partnership] introduced this morning supplies additional proof that the Firm has established processes that meet rigorous U.S. nationwide and state particular rules, and set the inspiration for related bulletins sooner or later as we proceed to construct our pipeline.”

Research Particulars – offered by Alzheimer’s Scientific Trial Consortium

Roughly 50% of individuals recognized with Alzheimer’s illness or different kinds of dementia will obtain hospice care on the finish of their life(1). Of those, greater than 70% might be prescribed psychiatric drugs for administration of agitation(2). There aren’t any authorised therapies or tips to help clinicians in addressing end-of-life agitation in dementia. Within the absence of applicable evidence-based tips, sufferers are sometimes prescribed a mixture of antipsychotics, sedatives, and opiates. These drugs typically result in undesirable unwanted effects, all of which are inclined to make the state of affairs even worse, reducing high quality of life for sufferers, and including burden to their care companions.

Current analysis means that derivatives of hashish may be helpful in controlling agitation and misery with out the unwanted effects of medicines generally used to deal with agitation. On this challenge, Keck Faculty of Medication has chosen to make use of a mixture of two drugs, THC and CBD. This challenge goals to check the efficacy of an oral mixture of THC and CBD, for the therapy of agitation in individuals with a prognosis of dementia who’re eligible for hospice and experiencing agitation. The proposed research consists of a 12-week, Section 2, multicenter, randomized, double-blind, parallel-group, placebo-controlled research, with major outcomes evaluating the efficacy and tolerability of a THC/CBD oral mixture at week 2 and secondary outcomes at week 12.

The research will recruit roughly 150 individuals from 20 medical trial websites in america over a two yr interval.

About MediPharm Labs

Based in 2015, MediPharm Labs specializes within the improvement and manufacture of purified, pharmaceutical-quality hashish concentrates, energetic pharmaceutical substances (API) and superior spinoff merchandise using a Good Manufacturing Practices licensed facility with ISO standard-built clear rooms. MediPharm Labs has invested in an knowledgeable, analysis pushed staff, state-of-the-art expertise, downstream purification methodologies and purpose-built amenities with 5 major extraction strains for supply of pure, trusted and precision-dosed hashish merchandise for its prospects. By means of its wholesale and white label platforms, MediPharm Labs formulates, develops (together with by sensory testing), processes, packages and distributes hashish extracts and superior cannabinoid-based merchandise to home and worldwide markets.

In 2021, MediPharm Labs acquired a Pharmaceutical Drug Institution License from Well being Canada, turning into the one firm in North America to carry a home Good Manufacturing License for the extraction of pure cannabinoids. The Firm carries out its operations in compliance with all relevant legal guidelines within the nations by which it operates.

Web site: www.medipharmlabs.com

(1) Reference: Alzheimer’s Illness Details and Figures, 2022 Annual Report, Alzheimer’s Affiliation

Reference: Gerlach LB, Fashaw S, Strominger J, Ogarek J, Zullo AR, Daiello LA, Teno J, Shireman TI, Bynum JPW. Tendencies in antipsychotic prescribing amongst 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 Remedy of Agitation and Aggression in Alzheimer’s Illness. CNS Medication. 2015 Aug;29(8):615-23.

Reference: Ruthirakuhan M, Lanctôt KL, Vieira D, Herrmann N. Pure and Artificial Cannabinoids for Agitation and Aggression in Alzheimer’s Illness: A Meta-Evaluation. J Clin Psychiatry. 2019 Jan 29;80(2):18r12617.

Alzheimer’s Scientific Trials Consortium (ACTC) is funded by a Cooperative Settlement from the Nationwide Institute on Growing older, Nationwide Institutes of Well being. Cooperative Settlement quantity U24AG057437.

Life’s Finish Advantages of Cannabidiol and Tetrahydrocannabinol (LiBBY)

Pls: Jacobo Mintzer, MD, MBA, Brigid Reynolds, NP

Period: 4 years

NIA/NIH Grant #: R01 AG068324-01

Cautionary Observe Relating to Ahead-Trying Info:

This information launch incorporates “forward-looking info” and “forward-looking statements” (collectively, “forward-looking statements”) throughout the that means of the relevant Canadian securities laws. All statements, aside from statements of historic reality, are forward-looking statements and are based mostly on expectations, estimates and projections as on the date of this information launch. Any assertion that includes discussions with respect to predictions, expectations, beliefs, plans, projections, targets, assumptions, future occasions or efficiency (typically however not all the time utilizing phrases similar to “expects”, or “doesn’t count on”, “is predicted”, “anticipates” or “doesn’t anticipate”, “plans”, “funds”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such phrases and phrases or stating that sure actions, occasions or outcomes “might” or “may”, “would”, “would possibly” or “will” be taken to happen or be achieved) will not be statements of historic reality and could also be forward-looking statements. On this information launch, forward-looking statements relate to, amongst different issues, statements concerning: thrilling alternatives forward; the anticipated outcomes of any medical analysis, the event of future hashish derived pharmaceutical medicine, being a low-capital avenue to analysis and future marketable pharmaceutical merchandise, and focusing on additional related initiatives. Ahead-looking statements are essentially based mostly upon a variety of estimates and assumptions that, whereas thought-about affordable, are topic to identified and unknown dangers, uncertainties, and different components which can trigger the precise outcomes and future occasions to vary materially from these expressed or implied by such forward-looking statements. Such components embody, however will not be restricted to: common enterprise, financial, aggressive, political and social uncertainties; the lack of MediPharm Labs to acquire ample financing; the delay or failure to obtain regulatory approvals; and different components mentioned in MediPharm Labs’ filings, obtainable on the SEDAR web site at www.sedar.com. There may be no assurance that such statements will show to be correct, as precise outcomes and future occasions may differ materially from these anticipated in such statements. Accordingly, readers shouldn’t place undue reliance on the forward-looking statements and knowledge contained on this information launch. Besides as required by legislation, MediPharm Labs assumes no obligation to replace the forward-looking statements of beliefs, opinions, projections, or different components, ought to they modify.

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