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Madeline Colli is the Associate Editor for Cannabis Patient Care and Cannabis Science and Technology magazines at MJH Life Sciences.
Avicanna Inc., is growing their epilepsy program through a collaboration with University Health Network.
Avicanna Inc., a biopharmaceutical company focusing on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products, announced that it has filed a master services agreement with the University Health Network (UHN) for projects to be performed by Dr. Peter Carlen as the principal investigator related to epilepsy (1). The company has already completed the technical transfer and first pharmaceutical pilot production of its epilepsy drug candidate at Altea Farmaceutica S.A. (Altea) in Bogota, Colombia, which highlights a major step that is required for the final preparation of its registration and commercialization in South America.
Dr. Peter Carlen is also a senior scientist at the Krembil Research Institute at UHN and a world-renowned researcher in the epilepsy field. Dr. Carlen’s laboratory will be evaluating Avicanna’s RHO Phyto and other pharmaceutical cannabinoid-based products for their efficacy in the treatment of seizures. Included in the partnership, they will also work on codeveloping a high throughput electrophysiological testing system for the evaluation of multiple cannabinoid ratios and in combination with standard epileptic drugs. The system will then screen standard antiseizure drugs for their efficacy in the model and establish the potential synergistic value of adjunctive cannabinoids and cannabinoids as monotherapy in treating seizures in an in vitro environment.
“We think that medical cannabinoids will have a major impact on brain health, particularly as we gain greater understanding of their effects on brain function in health and disease,” said Dr. Carlen (1).
Under the Master Services Agreement, Dr. Carlen’s laboratory has agreed to not conduct testing on any formulations or products similar to the Avicanna products for a period of two years. In addition, all intellectual property created under the agreement will remain the sole property of Avicanna. This collaboration will be broadened to include electrophysiological studies of medical cannabinoids on three-dimensional (3D) human cerebral organoids and neuroglial cultures with the assistance of a two-year Mitacs Accelerate program grant.
Aside from the joint collaboration, Avicanna completed their first pharmaceutical level production of its first epilepsy drug candidate under good manufacturing practices (GMP) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, which are required for sanitary drug registration. Avicanna’s formulation includes active pharmaceutical ingredients that are cannabinoids produced by the company’s subsidiary Santa Marta Golden Hemp S.A.S. Final GMP manufacturing occurred at Altea’s facility in Bogota, which is also a Health Canada and National Health Surveillance Agency (ANVISA - Brazil) approved GMP facility. The completed pharmaceutical production grants Avicanna permission to pursue drug registrations for epilepsy across several markets in South America, which include Colombia and Brazil.
“We are pleased to demonstrate our dedication to world-class research and to take this stride in our epilepsy research program with a leading Canadian research institute and Dr. Carlen,” said Aras Azadian, CEO of Avicanna (1). “This multi-level partnership will help to further study our current medical cannabis and pharmaceutical products, and will support the development and increase the depth of our pharmaceutical pipeline. Additionally, the completion of our first pharmaceutical production marks a milestone event in our drug development plans and highlights our capabilities to scale our drug formulations from bench top to industrial manufacturing.”