A new UK-based trial is set to assess the efficacy of GW Pharma’s cannabis-based drug Sativex as a potential treatment for patients with a recurrent glioblastoma – the most aggressive form of brain tumours.
The Phase II trial will launch following ‘promising’ results from a previous Phase I study of the drug in 27 patients.
In this study, researchers found that more patients were alive after one year in the Sativex arm compared to the placebo arm, although the trial was not ‘sufficiently powered’ to demonstrate survival impact.
The drug was also found to be tolerable when used in combination with chemotherapy in the early-stage trial.
The three-year Phase II trial, which will be led by professor Susan Short at the University of Leeds and coordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham, is expected to begin recruiting over 230 patients across the UK in early 2022 – subject to ‘sufficient funds being raised’.
Researchers will assess whether adding Sativex to the current standard chemotherapy treatment – temozolomide – can extend life (overall survival) and delay the progression of disease (progression-free survival) for adults diagnosed with a recurrence of their glioblastoma after initial treatment.
“The treatment of glioblastomas remains extremely challenging. Even with surgery, radiotherapy and chemotherapy, nearly all of these brain tumours re-grow within a year, and unfortunately there are very few options for patients once this occurs,” said Short.
“Cannabinoids have well-described effects in the brain and there has been a lot of interest in their use across different cancers for a long time now. Glioblastoma brain tumours have been shown to have receptors to cannabinoids on their cell surfaces, and laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide,” she added.
Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD as well as specific minor cannabinoids and other non-cannabinoid components.