Tilray Medical, a division of Tilray Brands, Inc., is supporting a new clinical trial in Spain to investigate the efficacy of medical cannabis in the treatment of glioblastoma, a severe form of brain cancer. The trial, commencing at University Hospital 12 de Octubre on September 5, 2023, involves the recruitment of 30 patients from eight specialized neuro-oncology medical sites.
Trial Details and Objectives
The clinical trial is being conducted in partnership with scientists from the Spanish Research Group of Neuro-Oncology (GEINO) and the Complutense University of Madrid. Tilray Medical is providing the pharmaceutical-grade medical cannabis (THC/CBD 1:1) for administration to patients. The trial is funded by the Medical Cannabis Bike Tour Foundation charity.
Denise Faltischek, Tilray’s Chief Strategy Officer and Head of International Business, stated, "This groundbreaking trial is more than an opportunity for Tilray to engage in medical research; it's a beacon of hope for patients suffering from Glioblastoma. Our role in this initiative exemplifies our commitment to medical research, leading us one step closer to unlocking the full therapeutic potential of medical cannabis."
The trial, led by Dr. Juan Manuel Sepúlveda Sánchez from GEINO, is a Phase I, open-label, multicenter, intrapatient dose-escalation study. It aims to evaluate the safety and profile of Tilray Medical’s T10:C10 (THC+CBD) extract when used in conjunction with temozolomide and radiotherapy for newly-diagnosed glioblastoma patients.
Rationale and Background
According to Dr. Juan Sepulveda, “Biological evidence has been accumulating for more than 15 years that cannabinoids have anti-tumor activity in the most aggressive brain tumors, glioblastomas. However, no clinical trials have been conducted to prove this hypothesis in patients. With this clinical trial, we can finally study the effect of cannabinoids on tumors that have not received active treatment. With this trial, we are helping to give our patients a new option, but also to open a therapeutic avenue."
Collaboration and Funding
The trial is the result of a 10-year civil society collaboration between the scientific sector and the medical cannabis community, with funding from the Medical Cannabis Bike Tour. Luc Krol from Paradise Seeds, founder of the Medical Cannabis Bike Tour, highlighted the significance of this independent funding of a clinical trial, emphasizing the hope illuminated by scientific research for the participants involved.
Tilray Medical’s mission is to continue transforming lives and fostering dignity for patients in need through access to medical cannabis. The company is a leading provider of EU-GMP certified medical cannabis products in 20 countries, with a comprehensive portfolio of THC and CBD products. Tilray has supported medical trials globally, studying the efficacy of medical cannabis as a treatment for various indications, including pediatric epilepsy, cancer-induced nausea and vomiting, and post-traumatic stress disorder.
