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.”
Reference
Ep 24, Part I: Data Transparency in Cannabis Testing with Yasha Khan
November 21st 2024Evan Friedmann interviews Yasha Khan, co-founder of MCR Labs, about his journey into the cannabis industry and his efforts to promote transparency and integrity in laboratory practices. Yasha discusses the origins of MCR Labs, which began in Massachusetts to meet the needs of the soon-to-be legal medical cannabis market. He explains the challenges faced, including result manipulation by labs and the impact on public health. Yasha's Freedom of Information Act (FOIA) project aimed to gather testing data from 37 states, revealed significant discrepancies in potency and mold results. Despite some states' reluctance to share data, Yasha has made much of this data public, leading to collaborative research and publications on various aspects of cannabis testing.
Assessing Cannabis as a Harm Reduction Strategy: Insights from a Large-Scale Study
November 19th 2024A New Zealand study aimed to assess cannabis use as a harm reduction tool. Findings highlight lifestyle factors, and suggest cannabis-focused harm reduction strategies in reducing other substance use such as alcohol.
Ep 23, Part III: Accreditation in the Cannabis Industry with Susan Audino
October 24th 2024In Part III of this episode, host Evan Friedmann is joined by Susan Audino, PhD, founder of S.A. Audino & Associates, LLC, and co-founder of Saturn Scientific, LLC, to examine the complexities of sampling in the cannabis industry, emphasizing the need for proper sampling plans, and methods.