Dec 7, 2022

Mawazo Writing Africa

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Major trial to establish if cannabis drug shrinks brain tumours

A new major trial of the cannabis-based drug Sativex to treat the most aggressive form of brain cancer is underway in the UK in 15 national hospitals.

This comes after medical cannabis was legalized in the UK in In 2018 and since, activists, researchers and scientists have been working hard to understand the potential benefits of medicinal cannabis as research was held back for decades due to the war on narcotics.

Scientists conducting Phase II trials at the University of Leeds are trying to assess whether adding Sativex – an oral spray containing the cannabinoids THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) – to chemotherapy could extend the lives of thousands diagnosed with recurrent glioblastoma (the most common and aggressive form of brain tumors reported each year in Eng land around 2,200 people are diagnosed).

They explain that almost all glioblastomas recur even after intensive treatment, including surgery, radiotherapy and chemotherapy, and the average survival time is only 12-18 months from the first diagnosis .

The researchers further add that several pre-clinical laboratory studies suggest that the cannabinoids THC and CBD could reduce the growth of brain tumor cells and disrupt the blood supply to tumors – but to date, the clinical evidence has been that they could treat brain tumors.

“Glioblastoma brain tumors have been shown to have receptors for cannabinoids on their cell surfaces, and laboratory studies of glioblastoma cells have shown that these drugs can slow tumor growth and work particularly well when used with temozolomide

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“Having recently shown that a specific cannabinoid combination, administered as an oral spray, can be safely added to temozolomide chemotherapy, we are excited very excited to build on these findings to assess whether this drug could help glioblastoma patients live longer in a major randomized study,” said Prof Susan Short, the study’s lead investigator and professor of clinical oncology and neuro-oncology at the university from Leeds, adding that treating glioblastoma remains a major challenge.

“Even with surgery, radiation therapy and chemotherapy, almost all of these brain tumors grow back within a year, and unfortunately there are very few few options for patients once this occurs.”

Mean Survival

The new three-year phase II study being led by the P rofessor, which is led and coordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham, is recruiting more than 230 patients across the UK this year.

Following promising results From a phase 1 study involving 27 patients University of Birmingham experts say their Phase 2 study “will assess whether adding Sativex to chemotherapy could extend the lives of thousands diagnosed with recurrent glioblastoma, which currently have a median survival of less than 10 months has”.

Sativex, already used to treat multiple sclerosis, was shown to be safe in combination with chemotherapy with the potential to extend survival in a phase 1 study last year.

The study observed that after one year more patients given Sativex were alive than those given placebo.

But i In this new Phase II study, researchers will assess whether adding Sativex to current standard of care chemotherapy (temozolomide) could offer additional life to adults who have been diagnosed with their glioblastoma recurrence after initial treatment.

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The researchers plan to recruit 232 participants in at least 15 hospitals, with two-thirds of participants will receive temozolomide plus Sativex, while a third will receive temozolomide plus placebo.

< p>The drug, manufactured by GW Pharma, is an oromucosal spray containing 1:1 THC and CBD , whereby the active ingredients are absorbed into the oral mucosa, either under the tongue or in the cheek, depending on the manufacturer of the drug.

Regular follow-up

” Participants are asked to give up to 12 Sprays per day (or up to the max dose they tolerate if less than 12) of Sativex or placebo oral sprays.

They will then undergo periodic follow-up, including clinical assessment (every four weeks), blood work, MRI scans (every eight weeks), and they’ll fill out quality of life questionnaires,” they note, adding that potential side effects identified during phase 1 trials include fatigue, headache, vomiting, and nausea.

In January 2019, the Director-General of the World Health Organization (WHO), Tedros Ghebreyesus, addressed a set of recommendations to the United Nations to update the scope of control of cannabis and cannabis-related substances.

The global health authority noted that these new recommendations reflect the emergency of strengthening the therapeutic role of cannabis-based medicines while preventing diversion, abuse and other Sc prevent health-related harm that may result from cannabis use.

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