Sativex to be Used in World’s First Brain Tumor Trial

Reports have it that medical trials are about to commence in the University of Leeds on the use of a medical cannabis drug called Sativex in treating brain tumors. Sativex will be used together with temozolomide, a recognized chemotherapy treatment. Hopes are hanging on the drug being able to kill off a significant amount of cancerous cells during the trials.

In England, an average of 2,200 people are diagnosed with the medical condition known as Glioblastoma. Medical experts claim it is one of the commonest forms of brain cancers observed in the UK.

This condition is highly aggressive and has a high rate of fatality in patients. Glioblastoma is a tumor that has over 70% probability of coming back, despite being treated by surgical procedures, radiotherapy as well as chemotherapy sessions.

Glioblastoma is more or less a death sentence right now. Patients have around 12-18 months to live when detected early. However, those with recurrent conditions have 10 months or less to live.

The drug called Sativex

This drug is a cannabis-based mouth spray. This is not the first time Sativex will be used in a medical trial. It has been tried and tested in treating medical conditions like multiple sclerosis. The trial concerning the multiple sclerosis conditions was successful and Sativex is now being administered to patients with muscle stiffness and spasms in a bid to reduce their spasticity.

The NHS approves the use of cannabis drugs; Sativex and Epidyolex in treating conditions. Sativex was the first to be approved in 2014 and it cost around £2,000 per patient.

The oromucosal drug, Sativex, contains the two major cannabinoids in equal amounts. The presence of both Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) produces therapeutic effects that reduce inflammation, anxiety, and pain. It is important to note that the drugs do not induce psychoactive effects when consumed.

Can Sativex Be Used To Manage Glioblastoma?

This is the question on everyone's mind. For this question to be answered, the clinical trials have to be completed. The University of Leeds is the first researcher in the world to consider the use of Sativex for brain tumor treatment.

Susan Short, one of the researchers involved in this study, said that the team believes that Sativex may be the missing piece in the medical puzzle of treating glioblastoma. Short, who is the Professor of clinical oncology and neuro-oncology, claims that Sativex may be able to kill the tumor cells when it is given with the temozolomide chemotherapy treatment.

The team thinks that these individual drugs will be most effective when they're used together. The Sativex is expected to boost the growth-halting effect of the chemotherapy treatment against glioblastoma tumors. The slower the growth rate of the tumor cells the longer the patient had to live.

The researchers are being backed by cancer charity organizations and the NHS in this clinical investigation. The results of this trial will determine if the lives of glioblastoma patients can be significantly extended with the use of the cannabis-based mouth spray.

One of the charity organizations, The Brain Tumour Charity is reported to be funding the trial. From January 2022, the organization will begin to recruit patients from 15 different hospitals that are recognized by the National Health Services across the UK. 232 patients are expected and some of them will be recruited from brain tumor specialist centers based in the UK.

The Trial

Before this experiment, an earlier study has been carried out to study the safety of combining Sativex with temozolomide. This study is regarded as the Phase I trial and it recruited 27 patients.

This trial—Phase II—will purposely study the impact of Sativex and temozolomide on the patient's survival rate. The trial has been named "The Aristocrat Study" and it will run for three years. The safety of the phase I regime will also be studied for a long time.

Professor Short has said that the initial studies carried out show that not only is the combination of the drugs safe, but it may also be the major step in giving some people extra months, or even years if they're fortunate. The patients will now be able to look forward to an improved quality of life while living with the condition.

The initial study also revealed that some patients might have problems with associated side-effects like sickness, dizziness, and fatigue, but Glioblastoma is a devastating disease, and any form of drug that will give patients hope is very welcome at this juncture.

The trial is set to begin in 2022. Two-thirds of the patients will be administered Sativex and temozolomide. The remaining will be given a placebo in addition to the chemotherapy drug; temozolomide.

Financing the trial

An estimated sum of £450,000 is needed to cover the costs of the trials. The Brain Tumor Charity having lost 25% of its income due to the fact that COVID-19 pandemic halted its usual program of research grants. It has stressed that the results of the appeal to help cover the estimated sum are very important to the start and success of the trial.

Dr. David Jenkinson, the interim chief executive of The Brain Tumour Charity shared that the organization hopes the Aristocrat study would pave the way for the much-needed extended lifelines that would help glioblastoma patients have extra months to live and make more memories with their family and friends.

Dr. David also expressed the organization's excitement at being part of the first team to carry out this trial— about the potential activity of cannabis drugs in treating brain tumors—in the world.

In Conclusion

Important trials like this are essential to the future of cancer treatments. As they will help to understand how drugs like cannabis and the chemicals present in it can be used to kill or halt the growth of aggressive cancer cells.

The phase I of the trial which was not adequately powered to show the extent of survival impact managed to show that patients placed on the Sativex plus temozolomide treatment have a higher survival rate than those placed on the placebo.

Now, imagine just how much information will be gotten from the aristocrat study with all things put in place.