Cannabinoid-focused biopharmaceutical company Greater Cannabis Company, Inc. GCAN has submitted a clinical trial application to the Israel Ministry of Health for approval of Phase 2 clinical trial for its novel neuropsychiatric cannabinoid therapy.
The company seeks to conduct a Phase 2 clinical trial spearheaded by the principal investigator, Dr. Adi Aran, to study the safety and efficacy of its neuroprotective cannabinoid therapeutic to treat autism-related spectrum disorders (ASD) and other neuropsychiatric illnesses.
The study will be conducted as a double-blind, placebo-controlled trial with 100 patients aged 4-17 years old. The researchers are expected to begin enrolling patients in the first half of 2023, pending approval of the Health Ministry, and to run for 12 to 18 months, including a possible open-label phase.
“We are excited to take this next step in the advancement of our novel therapeutic to clinical trials,” Aitan Zacharin, CEO of GCANRx, said. “ASDs are common and lifelong neurodevelopmental disabilities with a substantial emotional and economic impact on the individual, family, and society. Despite worldwide efforts, currently, there is no conventional pharmacological treatment for the core symptoms of ASD, leaving patients and families with an unmet need. Positive results in this study carry promise for a novel treatment for ASD as well as for other neuropsychiatric disorders such as schizophrenia, Alzheimer’s disease, and Parkinson’s disease, which share similar pathophysiological processes and can have an enormous impact on the lives of countless families as well as on public health.”
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