Nora Topicals
The Greater Cannabis Company, also known as GCANRx, is a publicly-traded biopharmaceutical company based in Baltimore, Maryland. The company has sought to develop and commercialize a new therapy for neuropsychiatric disorders that reduces disruptive symptoms without the side effects of existing medications.
In 2021, GCANRx announced its license and research agreement with Shaare Zedek Scientific, the technology transfer arm of the Shaare Zedek Medical Center in Jerusalem and home to prominent cannabinoid researcher, Adi Aran.
Aran, the director of pediatric neurology at Shaare Zedek Medical Center, is known for his study on cannabinoids in autistic children and is believed to be the inventor of cannabinoid neuropsychiatric therapy. He was also appointed as the strategic advisor and lead of the clinical research for GCANRx.
The preclinical trials, announced in late 2021, were led by Tal Burstyn-Cohen, a prominent brain cancer researcher at The Hebrew University of Jerusalem. The trials were a follow-up to previous studies on the effects of CBD oil on children with autism.
As GCANRx notes, Aran conducted his original study in 2017, which is believed to be the world’s most comprehensive study on these effects and the first double-blind placebo-controlled trial of its kind. His study, and a similar study conducted in 2019, showed a positive correlation between CBD and reduced behavioral disturbances.
GCANRx took this data and decided to study the effects further with its own proprietary compounds for autism and other neuropsychiatric disorders, such as Parkinson’s Disease, Alzeheimer’s Disease, schizophrenia and epilepsy.
Separately, the compounds had a limited efficacy as treatment, when combined with CBD however, they showed the potential to significantly reduce disruptive behavior and some symptoms without the side effects of current treatments on the market.
Phase II of the clinical trial was approved by the Israeli Ministry of Health in July 2023, and was followed by the official press release to Globe Newswire announcing the completion and promising results of the preclinical trial in February 2024.
The press release of the trial approval from 2023 details that the primary objective of the clinical trial is “to evaluate safety and tolerability of GCANRx’s proprietary therapeutic (between 4 and 13 years of age) using a daily oral treatment.”
The trial will have a double blind, placebo-controlled study to help assess the change in behavior and monitor reactions in the CBD treatment and placebo group over the course of 12 weeks.
Behavior change will be assessed using the Aberrant Behavior Checklist (ABC), a standardized rating scale developed in early 1980s to assess the treatment effects in people with intellectual disabilities, and more specifically using the Irritability Subscale (ABC-I) to focus on behaviors including temper outbursts, negative mood, aggression and self-harm.
The clinical trials will also assess the effects using the third edition of the Vineland™ Adaptive Behavior Scales and the second edition of the Social Responsiveness Scale to assess other baselines of behavior changes as well.
Evidence will continue to be collected as clinical trials proceed over the next year, however, the positive results from the preclinical study show that the therapy has a neuroprotective effect so there are high hopes for success in finding a minimal side effect treatment for these neuropsychiatric disorders.
Jane Dimel is a contributing writer at CityScene Media Group. Feedback welcome at feedback@cityscenemediagroup.com.
