GCANRx Announces Approval of Phase II Clinical Trial to Treat Autism Related Spectrum Disorders

BALTIMORE, July 05, 2023 (GLOBE NEWSWIRE) -- Greater Cannabis Company, Inc. (“GCANRx” or the “Company”) (OTC: GCAN) a publicly traded biopharmaceutical company pioneering development of next generation therapeutics is pleased to announce that it has been granted final approval for its double blind, placebo controlled Phase II Clinical Trial for the treatment of Autism Spectrum Disorder (ASD) from the Israel Ministry of Health.

The Company previously announced that it is planning to conduct a Phase II clinical trial spearheaded by principal investigator, Dr. Adi Aran, M.D., to study the safety and efficacy of its neuroprotective cannabinoid therapeutic to treat autism related spectrum disorders (ASD) and other neuropsychiatric disorders such as Parkinson’s Disease, Alzheimer’s Disease, schizophrenia, and epilepsy.

The primary objective of the clinical trial is to evaluate the efficacy, safety and tolerability of GCANRx’s proprietary therapeutic in pediatric patients (between 4 and 13 years of age) using a daily oral treatment. The patients will be randomized in a 1:1 ratio to receive either GCANRx’s therapeutic or a matched placebo. The primary efficacy objective of the study will be to assess the effect of the neuroprotective therapeutic compared to placebo on behavioral problems, using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I) score - change from baseline to week 12. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for therapeutic and placebo groups. The main secondary objective is to assess the effect of the neuroprotective therapeutic compared to placebo on the core ASD symptoms using the Vineland TM Adaptive Behavior Scales (3rd edition, VABS3)- 2-Domain Composite Score, and Social Responsiveness Scale 2nd edition (SRS-II) total score - change from baseline to week 12. The study, which will be conducted in Israel, is expected to begin enrolling patients in the coming weeks.

ASD is a life long condition with no cure that affects 7 million people in the US (about 5.4 million adults), and over 75 million people globally. Current pharmaceutical therapies are only minimally effective and have significant side effect profiles including obesity and altered hormone production. The cost of caring for autistic Americans reached $268 billion in 2015 and could increase to $461 billion by 2025, with the total cost of medication to treat estimated to be $37 billion. Today there are 1.5 million people already using CBD to treat ASD in the US. A recent survey found that 22.6% of parents are using CBD for their ASD child, with annual spending on CBD to treat ASD symptoms exceeding $1.85 billion.