MediCane Health Inc. Announce First Patient Enrolled in a Phase IIa Clinical Trial of MediCane’s Balanced T3:C3 Oral Medical Cannabis Oil for Symptom Relief of Behavioral and Psychological Symptoms of Dementia (BPSD)Posted by On

KFAR SAVA, Israel–()–MediCane Health Inc. (along with its subsidiaries together referred to as “MediCane”) today announced the recruitment of the first patient for its clinical study designed to achieve relief of agitation and disruptive behaviors in subjects with probable Alzheimer’s disease (AD) who do not respond or only partially respond to treatment with antipsychotic medications.

The trial is being conducted in two leading academic hospitals in Israel, Sheba Medical Center and Sourasky Medical Center. A total of 55 subjects will receive MediCane’s balanced T3:C3 oral medical cannabis oil extracted from MediCane’s proprietary strain and formulated for blinding purposes, on top of standard of care. Part one of the study is an open-label phase that will enroll 15 subjects for safety and dose-range finding; Part two is a randomized, double-blind, placebo-controlled phase that will enroll 40 subjects to evaluate safety and efficacy.

The study is co-funded by Dr. Reddy’s Laboratories, a leading multinational pharmaceutical company, which holds exclusive sales and marketing rights for the product in Europe (except CIS countries).

“MediCane is proud to collaborate with two of the leading medical centers in Israel in our journey to find a safe and effective cannabis-based medicine for BPSD symptom relief,” said Dr. Nurit Tweezer-Zaks, Chief Executive Officer of MediCane R&D. “Through this joint effort and with the active collaboration of Dr. Reddy’s Laboratories we hope to be able to successfully complete the study during 2024 and launch the product in Israel, Germany and additional EU markets.”

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“The mission of MediCane Health Inc. is to develop evidence-based treatments created from cannabis plants in its derived molecules. We see symptom reduction as a clinically meaningful goal of the cannabis plant for BPSD,” said Dr. Neta Rimmerman, VP MediCane R&D. “Based on our proprietary strain cultivated in Israel, we developed an oil-based formulation that showed promising results in pre-clinical research.”

Alzheimer’s disease is a chronic neurodegenerative disease that accounts for most dementia cases worldwide. Dementia is a syndrome in which there is deterioration in memory, thinking, behavior, and the ability to perform everyday activities. Among the Behavioral and Psychological Symptoms of Dementia (BPSD), agitation and disruptive behaviors, expressed as excessive fidgeting, restlessness, pacing, shouting, screaming, uninhibited behaviors, and aggression, are present in over half of patients with dementia at some point during the illness. This syndrome has significant negative consequences on the patient’s life and the lives of those around him, and it causes severe dependence on others and considerable fatigue on the main caregiver.

“The toolbox available to the treating physicians today to deal with BPSD symptoms is very limited,” according to Co-Principal Investigator Professor Ramit Ravona-Springer, Director of the Psychogeriatric and Memory Clinic at the Sheba Medical Center. “Our goal is to add cannabis-based treatments to the existing treatment arsenal to achieve symptom relief in a non-sedative manner which will provide caregivers with the opportunity to continue effective home care to their loved ones. My team and I are excited to lead this innovative clinical trial for the benefit of patients in Israel and around the world.”

“Me and my team are delighted to join the critical mission of helping dementia patients and their families,” said Co-Principal Investigator Dr. Noa Bergman, Director of the Memory and Attention Disorders Center, Neurology Department at the Sourasky Medical Center. “The balancing act of the available treatment options is very challenging as the risks might often outweigh the benefits. We witness the suffering of the patients and caregivers daily and are committed to collaborate with MediCane Health to find alternative cannabis-based solutions relying on robust clinical evidence.”

About MediCane’s balanced T3:C3 oil

MediCane’s balanced T3:C3 oil is an oral medical cannabis oil extracted from MediCane’s proprietary strain in GMP-grade olive oil, which is based on a marketed balanced T3:C3 (THC:CBD) MediCane product. During the clinical trial, MediCane’s balanced T3:C3 is administered sublingually using a dropper, three times a day, following a designated titration protocol.

About MediCane Health Inc.

MediCane Health Inc. is a fully integrated International Medical Cannabis Company. Its subsidiaries M.H MediCane Ltd. And MediCane R&D Ltd. develop both Medical Cannabis, as well as pharmaceutical products derived from synthetic and isolated cannabis molecules, in three therapeutic areas: Dementia, Insomnia, and IBS (irritable bowel syndrome). MediCane’s R&D activities are carried out in-house by its experienced team and through collaboration with world-renowned scientists and leading research institutions, which provide the analytical, biological, and medical expertise. Using a patient-centric approach to clinical trials, MediCane aims to provide potent cannabis-based pharmaceutical products to treat inflammatory and neurological diseases.

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