Tilray Medical, a division of Tilray Brands, Inc. (“Tilray” or the “Company”) (Nasdaq: TLRY; TSX: TLRY), a global medical cannabis leader, has announced its support for a groundbreaking clinical trial aimed at exploring the potential of medical cannabis in the treatment of glioblastoma, a highly aggressive form of brain cancer. The independent clinical trial, set to take place in Spain, will enroll 30 patients from eight specialized neuro-oncology medical centers, in collaboration with esteemed scientists from the Spanish Research Group of Neuro-Oncology (GEINO) and the Complutense University of Madrid. Tilray Medical will provide pharmaceutical-grade medical cannabis for the study (THC/CBD 1:1), which will be administered to patients. This initiative is funded by the Medical Cannabis Bike Tour Foundation charity and is scheduled to commence on September 5, 2023, at the University Hospital 12 de Octubre.
Denise Faltischek, Tilray’s Chief Strategy Officer and Head of International Business, expressed, “This groundbreaking trial represents not only an opportunity for Tilray to engage in medical research but also a ray of hope for Glioblastoma patients. Our involvement in this effort underscores our dedication to medical research, bringing us closer to unlocking the full therapeutic potential of medical cannabis.”
Under the leadership of Dr. Juan Manuel Sepúlveda Sánchez from GEINO, the clinical trial, a Phase I, open-label, multicenter, intrapatient dose-escalation study, will evaluate the safety and efficacy of Tilray Medical’s T10:C10 (THC+CBD) extract in combination with temozolomide and radiotherapy for newly-diagnosed Glioblastoma patients. This endeavor marks a significant milestone in the ongoing journey to harness the power of medical cannabis for patient treatment, resulting from a decade-long collaboration between the scientific community and advocates of medical cannabis. Dr. Juan Sepulveda notes, “Biological evidence has accumulated for more than 15 years, suggesting cannabinoids have anti-tumor properties in aggressive brain tumors, such as glioblastomas. However, clinical trials confirming this hypothesis in patients have been lacking. With this clinical trial, we can finally explore the impact of cannabinoids on tumors that have not received active treatment, opening new therapeutic possibilities. This trial is a product of cooperation between civil society, an emerging pharmaceutical company, and clinical scientists.”
In 2013, the Medical Cannabis Bike Tour commenced raising funds to support the research of the Cannabinoid Signaling Group at Complutense Madrid University, which was investigating the effects of cannabinoids on cancer cells and their potential in glioblastoma treatment. Today, thanks to the dedication of the European cannabis community, led by Luc Krol from Paradise Seeds, a Netherlands-based cannabis genetics seed bank, the Medical Bike Tour Foundation can independently fund a clinical trial in the pursuit of scientific advancement. Tilray Medical continues to be a driving force in transforming lives through access to medical cannabis and is a prominent supplier of EU-GMP certified medical cannabis products in over 20 countries, offering a comprehensive range of THC and CBD-based products. The company has been at the forefront of supporting medical trials worldwide, exploring the potential of medical cannabis in various medical indications, including pediatric epilepsy, cancer-induced nausea, and post-traumatic stress disorder.