Cannabis Charity Funds Clinical Trial Brain Cancer Trial

While medical cannabis research is not unusual today, 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.

Over the next 18 months, the trial will study the synergistic antitumor effect observed in the pre-clinical stage of combining Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) with traditional cancer treatments using temozolomide and radiotherapy

Conducted across eight specialized neuro-oncology medical sites in Spain, the study will recruit 30 patients and be led by esteemed coordinating investigator Dr. Juan Manuel Sepúlveda Sánchez from GEINO and collated by MFAR.

The partners involved are scientists from Complutense University of Madrid, Canadian medical cannabis provider Tilray Medical which prepared the pharmaceutical-grade medication for the trial (THC/CBD, 1:1, p.o.), and and the Medical Cannabis Bike Tour Foundation charity which is providing independent funding for the trial.

 In 2013 the Medical Cannabis Bike Tour began raising funds to support the work of the Complutense University team. Headed up by Dr Manuel Guzmán and Dr Guillermo Velasco, the team was researching the effects of cannabinoids on cancer cells and the potential as a glioblastoma treatment. 

It was founded by Luc Krol from the Netherlands based cannabis genetics seed bank, Paradise Seeds and Matej Munih from Snail Rolling Papers. The Medical Bike Tour Foundation mobilized the European cannabis community, attracting significant sponsorship from the industry over the course of five events. The proceeds are funding the clinical trial.

Over 400,000 Euros was raised over the course of the bike tours which took place in Spain (x2), Holland/Germany/Belgium, Slovenia/Italy, Czechia/Austria. The tours were documented on YouTube and social media.

The involvement of GEINO (Spanish Group of Neuro-Oncology Research) paved the way for the trial to become a reality, with Tilray Medical coming on board to provide EU-GMP certified medical cannabis THC and CBD products for administering to patients.

This unique partnership has come together in a groundbreaking initiative, working together for the benefit of cancer treatment research as the trial investigates the potential benefits of medical cannabis.  

A word from the partners:

Dr. Juan Sepulveda (GEINO) said, “Biological evidence has been accumulating for more than 15 years that cannabinoids have anti-tumour activity in the most aggressive brain tumours, glioblastomas. However, no clinical trials have been conducted to prove this hypothesis in patients, perhaps due to the lack of commercial interest in these drugs. With this clinical trial, we can finally study the effect of cannabinoids on tumours that have not very active treatment.

With this trial, we are helping to give our patients a new option, but also to open up 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 basic and clinical scientists.”  

Dr Guillermo Velasco (Complutense University and IdISSC) said, “This trial represents a crucial milestone in the study of the antitumoral action of cannabinoids, a long-term project that we have developed for more than 20 years now. Stemming from initial almost serendipitous observations that Δ9-tetrahydrocannabinol (THC) has the ability to promote glioma cell death, our work led us to understand the mechanism by which cannabinoids exert their anticancer actions in brain tumor cells.

Likewise, our preclinical studies in animal models demonstrated a promising synergistic antitumor effect when combining Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) with temozolomide thereby contributing to set the scientific bases for the development of this clinical study. As a basic scientist, being able to translate our findings into something potentially useful for patients is the maximal aspiration and therefore we are thrilled to see that the study is commencing.

We are extremely thankful to all who have made possible this trial including our partners in this exciting long-term project: Medical Cannabis Bike tour, GEINO, Tilray and MFAR as well as past and present researchers in our group and all our national and international collaborators. Hopefully the results of the trial will contribute to provide a new hope and therapeutic option for Glioblastoma patients.”

Luc Krol (Medical Cannabis Bike Tour) added, ”The world was very different when we began the MCBT 10 years ago. In the pre-legalization era, the term ‘medical cannabis’ was still seen by many people as a fantasy. However we believed in the outstanding work of doctors Velasco and Guzman and their team and asked the cannabis community to support it.

The fact that the MCBT can independently fund a clinical trial in the name of science, not profit, 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.” 

Denise Faltischek (Tilray’s Chief Strategy Officer and Head of International Business), stated, “This groundbreaking trial is more than an opportunity for Tilray; it’s a beacon of hope for patients suffering from Glioblastoma. Our role in this initiative amplifies our commitment to medical research, leading us one step closer to unlocking the full therapeutic potential of medical cannabis.”