Israeli medical cannabis company InterCure Ltd. announced that its wholly-owned subsidiary Canndoc initiated a phase 3 clinical trial with the Shamir Medical Center (Assaf HaRofeh) for the treatment of children with autism spectrum disorder.
The program will be led by Dr. Orit Stoller, a pediatric neurologist at the Autism Center at Shamir (Assaf HaRofeh), and Prof. Mati Berkovitch, Head of the Clinical Pharmacology Unit at the Shamir Medical Center (Assaf HaRofeh), validating the safety and efficacy of Canndoc's GMP pharma grade cannabis product T1/C20 for children with autism spectrum disorder.
Enrolment in the study of approximately 100 patients age 8-18 is already underway, marking this study one of the most advanced pharma grade medicinal cannabis clinical trial.
Canndoc already supplies pharma grade cannabis products made to GMP standards, prescribe by physicians to patients in Israel and soon in other countries.
Canndoc's medicinal cannabis clinical pipeline includes late stage studies validating its GMP pharma-grade cannabis products for epilepsy, fibromyalgia, neuropathic pain, side effects of chemotherapy in cancer patients, Parkinson's disease, rheumatic arthritis, radicular pain, posttraumatic stress disorder (PTSD), and lumbar radiculopathy.
Alon Granot, CEO of Canndoc: "Our late stage clinical trial pipeline places Canndoc at the forefront of global clinical GMP-standard medical cannabis research. We are delighted to initiate phase 3 trial with the most experienced and devoted physicians team bringing hope to these special kids and their families."
Dr. Stoller, paediatric neurologist at the Autism Center of Shamir Medical Center (Assaf HaRofeh) and Alut: "The prevalence of the autism spectrum is increasingly growing with the present rate at 1 to 59 according to U.S. data. Many families of children with autism spectrum disorder cope with significant difficulties in their lives. The present conventional medicinal treatment provides a partial solution. In recent years, the consumption of medical cannabis by this demographic has been increasingly growing, and it appears that medical cannabis better addresses some of the morbidity symptoms associated with the autism spectrum. This ground-breaking and first-of-its-kind trial aim to examine the effect of medical cannabis treatment on cognitive functioning, the core symptoms of the autism spectrum, in addition to the endocrinal system, sleeping, eating, restlessness, violence and anxiety. This information is essential for establishing the legitimacy and the manner of treatment with medical cannabis as part of the healthcare basket offered to children with autism."
Abigail Dar, who heads the CannaFora Center and has been leading the treatment of children with autism spectrum disorder with medical cannabis for years, state: "In my experience in the treatment of diagnosed children, Canndoc products have a proven success rate in alleviating symptoms and contributing to both the children's and their families' quality of life."
For more details, visit: www.canndoc-pharma.com