A MediCane is conducting a clinical trial with 55 subjects to assess the potential of medical cannabis on the Behavioral and Psychological Symptoms of Dementia (SCPD). The study takes place at two research centers in Israel, in partnership with Dr. Reddy, who owns the marketing rights in Europe for the formulation used in the study. The study is expected to be completed in 2024.
MediCane Health Inc. is an Israeli multinational company with operations in Campo Maior, Portugal, and announced that it has recruited its first patient for a clinical trial designed to assess relief in behavioral and psychological symptoms of Dementia (SCPD), such as agitation and disruptive behaviors in individuals with probable Alzheimer's disease (AD).
The trial is the consolidation of a partnership announced mid-year between Medicane and Dr. Reddy, who in addition to being co-financiers of the trial, also hold the exclusive rights to commercialize the formulation used in the trial, as well as the cannabis produced in Portugal and exclusive distribution in the German market.
The trial is taking place at two teaching hospitals in Israel, the Sheba Medical Center e Sourasky Medical Center🇧🇷 In all, a universe of 55 individuals will be evaluated, who will receive medicinal cannabis oil (MediCane's T3:C3) orally, extracted from a MediCane's own cultivar. The trial is comprised of two phases, the first of which will involve 15 individuals to assess safety and determine dosing intervals, and a second phase of 40 individuals to assess drug safety and efficacy through a double-blind, randomized design. blinded and placebo-controlled.
MediCane's T3:C3 is not grown in Portugal, but could reach the Portuguese
MediCane T3:C3 Oil is an oral medicinal cannabis oil extracted from a cultivar owned by MediCane in GMP olive oil. Medicane Health Inc is an Israeli company that has medical cannabis cultivation operations in Portugal through the subsidiary company MHI Cultivo Medicinal, in Campo Maior. Regarding the origin of the medicinal cannabis used in the formulation, Vera Broder Koshet, CEO of the Portuguese company, denied to Cannareporter that the raw material used was actually grown on Portuguese soil.
However, this does not mean that the Portuguese cannot have the possibility of finding this product in Portuguese pharmacies in the future, given the intentions of marketing this product in Europe, something also confirmed by Vera Broder.
Study will be completed in 2024
“MediCane is proud to collaborate with two of Israel's leading medical centers on our journey to find a safe and effective cannabis-based drug,” said Dr. Nurit Tweezer-Zaks, CEO of MediCane R&D, who added: “Through this joint effort and with the active collaboration of Dr. Reddy hopes to be able to successfully complete the study in 2024 and launch the product in Israel, Germany and other EU markets.”
According to Professor Ramit Ravona-Springer, Director of the Psychogeriatric and Memory Clinic at Sheba Medical Center and co-principal investigator, therapeutic alternatives in these cases are limited and the aim is to add cannabis-based treatments to the arsenal of existing treatments to obtain symptom relief in a non-sedative manner, which will provide caregivers with the opportunity to continue home care effective for patients. “My research team and I are excited to be running this groundbreaking clinical trial for the benefit of patients in Israel and around the world,” she said.
At the Center for Memory and Attention Disorders, Department of Neurology at Sourasky Medical Center, co-principal investigator Dr. Noa Bergman added: “The balance of available treatment options is very challenging as the risks can often outweigh the benefits. We witness the suffering of patients and caregivers daily and are committed to collaborating with MediCane Health Inc to find alternative cannabis-based solutions based on robust clinical evidence.”