Cannabis-based oral spray could kill brain tumours, study to launch next year
pharmafile | August 3, 2021 | News story | Manufacturing and Production, Medical Communications, Research and Development |
The NHS alongside cancer charities are set to launch a clinical trial to investigate the effects of a cannabis-based oral spray on recurrent brain tumours, known as glioblastomas.
The spray, which is known as Sativex, consists of two equal amounts of cannabinoids: the psychoactive substance Delta-9-tetrahydrocannabinol (THC), which gives users a “high”, and cannabidiol (CBD), which can help reduce pain, inflammation and anxiety without inducing any psychoactive effects.
In the trial, which will be called the Aristocrat study, Sativex will be administered alongside a chemotherapy medication – temozolomide – in an attempt to kill off cancerous cells. It will be the first such study in the world.
The Brain Tumour Charity, which is funding the trial, will recruit 232 patients early next year from at least 15 hospitals, including specialist cancer centres, across the UK. Two-thirds will receive Sativex and temozolomide while the other third will be given the chemotherapy drug and a placebo.
Dr David Jenkinson, the Brain Tumour Charity’s Interim Chief Executive, said: “We hope this trial could pave the way for a long-awaited new lifeline that could help offer glioblastoma patients precious extra months to live and make memories with their loved ones.
“We know there is significant interest in our community about the potential activity of cannabinoids in treating glioblastomas, and we’re really excited that this world-first trial here in the UK could help to accelerate these answers.”
Glioblastomas are an aggressive and hard-to-treat form of brain tumour that almost always come back, despite surgery, radiotherapy, and chemotherapy. Those diagnosed only live for 12 to 18 months while those with a recurrent glioblastoma survive for just 10 months. About 2,200 people in England are diagnosed every year with the condition, making it the commonest form of brain cancer.
Sativex is already used to treat those with multiple sclerosis whose condition has not improved despite treatment, in order to reduce their spasticity. It is one of three cannabis-based medicines currently in use in the NHS.
Susan Short, a professor of clinical oncology and neuro-oncology at Leeds University and principal investigator of the study, said: “We think that Sativex may kill glioblastoma tumour cells and that it may be particularly effective when given with temozolomide chemotherapy, so it may enhance the effects of chemotherapy treatment in stopping these tumours growing, allowing patients to live longer.”
The planned three-year Aristocrat study follows the successful Phase I study evaluating the safety of Sativex and temozolomide in 27 patients. The new study is being coordinated by Cancer Research UK’s clinical trials unit at Birmingham university, and has been dependent on public appeals for the £450,000 in funds.
Dr Jenkinson added: “The recent early-stage findings were really promising and we now look forward to understanding whether adding Sativex to chemotherapy could offer life extension and improved quality of life, which would be a major step forward in our ability to treat this devastating disease.”
Kat Jenkins
