CANTANHEDE, PORTUGAL– October 16, 2023 – Tilray Medical, a division of Tilray Brands, Inc. ("Tilray" or the "Company") (Nasdaq: TLRY; TSX: TLRY) and a global leader in medical cannabis, empowering the therapeutic alliance between patients and healthcare practitioners to make informed individualized health decisions, transforming healthcare, today announced their contribution to an independent clinical trial to research the efficacy of medical cannabis as a treatment for glioblastoma, a severe form of brain cancer. The clinical trial will be conducted in Spain, recruiting 30 patients from eight specialized neuro-oncology medical sites, in partnership with renowned scientists from the Spanish Research Group of Neuro-Oncology (GEINO) and the Complutense University of Madrid, with Tilray Medical providing the pharmaceutical-grade medical cannabis for the trial (THC/CBD 1:1) for administration to patients.. The trial is funded by the Medical Cannabis Bike Tour Foundation charity and is scheduled to commence at University Hospital 12 de Octubre, on September 5, 2023.
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."
Led by esteemed coordinating investigator Dr. Juan Manuel Sepúlveda Sánchez from GEINO, the clinical trial is a Phase I, open-label, multicenter, intrapatient dose-escalation to evaluate the safety and profile of Tilray Medical’s T10:C10 (THC+CBD) extract, in conjunction with temozolomide and radiotherapy for newly-diagnosed Glioblastoma patients.
While medical cannabis research has been an ongoing mission towards patient treatment, this trial is unique because it is the culmination of a 10-year civil society collaboration between the scientific sector and the medical cannabis community. 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. The trial is the result of a collaboration between civil society through the Medical Cannabis Bike Tour, an emerging pharmaceutical company and clinical scientists.”
In 2013, the Medical Cannabis Bike Tour began raising funds to support the work of the Complutense Madrid University team. Guided by Dr. Manuel Guzmán and Dr. Guillermo Velasco, the team at Cannabinoid Signalling Group was researching the effects of cannabinoids on cancer cells and the potential as a glioblastoma treatment. Today, with proceeds from the Medical Cannabis Bike Tour founded by Luc Krol from the Netherlands-based cannabis genetics seed bank, Paradise Seeds, the Medical Bike Tour Foundation mobilized the European cannabis community. It attracted significant sponsorship from the industry over the course of five events held in different European countries who were advocates for the impact of medical cannabis and its benefits. As a result, Luc Krol passionately adds, “The world was very different when we began the Medical Cannabis Bike Tour 10 years ago. We believed in the outstanding work of doctors including Dr. Guzman and Velasco and their team and asked the cannabis community for their support. The fact that the Medical Cannabis Bike Tour can now independently fund a clinical trial in the name of science, is amazing thanks to the sponsors and riders who made it happen. We hope this trial will reflect the hope illuminated by the 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, and today 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, across Europe, Canada, the United States, Australia, and Latin America, studying the efficacy of medical cannabis as a treatment for indications including pediatric epilepsy, refractory pediatric epilepsy, cancer-induced nausea and vomiting, HIV, essential tremor, breast cancer disorders, post-traumatic stress disorder, and alcohol use disorders.
About Tilray Medical
Tilray Medical is dedicated to transforming lives and fostering dignity for patients in need through safe and reliable access to a global portfolio of medical cannabis brands, including Tilray, Aphria, Broken Coast, Symbios and Navcora. Tilray grew from being one of the first companies to become an approved licensed producer of medical cannabis in Canada to building the first GMP-certified cannabis production facilities in Europe, first in Portugal and later in Germany. Today, Tilray Medical is one of the largest suppliers of medical cannabis to patients, physicians, hospitals, pharmacies, researchers, and governments, in 20 countries and across five continents.
For more information on Tilray Medical, visit Tilray Medical Europe, Tilray Medical Canada, and Tilray Medical Australia-New Zealand.
About Tilray Brands
Tilray Brands, Inc. (Nasdaq: TLRY; TSX: TLRY), is a leading global cannabis-lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people's lives for the better – one person at a time. Tilray Brands delivers on this mission by inspiring and empowering the worldwide community to live their very best life and providing access to products that meet the needs of their mind, body, and soul while invoking wellbeing. Patients and consumers trust Tilray Brands to deliver a cultivated experience and health and wellbeing through high-quality, differentiated brands and innovative products. A pioneer in cannabis research, cultivation, and distribution, Tilray’s unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.
For more information on how we open a world of wellbeing, visit www.Tilray.com.
Cautionary Statement Concerning Forward-Looking Statements
Certain statements in this press release constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication.
Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Many factors could cause actual results, performance or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of the Company and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of the Company made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities laws.
Contacts:
Tilray Brands:
Berrin Noorata
news@tilray.com
Investors
Raphael Gross
203-682-8253
Raphael.Gross@icrinc.com
Medical Cannabis Bike Tour Foundation
