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Tilray, Inc. announced that one of their GMP products is showing a potential benefit in reducing nausea and vomiting caused by chemotherapy.
Tilray, Inc., a Canadian-based pharmaceutical and cannabis company focused on cannabis research, production, cultivation, and distribution announced that Australian researchers published preliminary results showing that one of the company’s good manufacturing practice (GMP) products revealed a reduction in nausea and vomiting seen in cancer patients undergoing chemotherapy(1,2). These findings are part of the world’s first clinical trial using cannabis called CannabisCINV, which aims to determine if an anti-emetic regimen incorporating oral tetra-hydrocannabinol (THC)/cannabidiol (CBD) is more effective than a guideline-consistent anti-emetic regimen for the secondary prevention of chemotherapy-induced nausea and vomiting (CINV), during three consecutive cycles of chemotherapy (2,3).
When it launched, the CannabisCINV study was the world’s largest trial of medical cannabis. It is a collaboration between Chris O’Brien Lifehouse, the University of Sydney, the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, and leading New South Wales (NSW) cancer centres. Tilray, Inc, is supplying the medicinal cannabis involved in the trial, which is being funded by the NSW government.
The study’s results were published in the Annals of Oncology (4), demonstrating significant improvement in the control of chemotherapy-induced nausea and vomiting. A quarter of the patients in this trial that were using medicinal cannabis responded with no vomiting and nausea. These results are promising when compared to 14% of the patients who were given a placebo. The first phase of the study took place for two and a half years, enrolling 81 participants. For individuals to be included in the study, patients had to previously been suffering from vomiting and nausea during their chemotherapy treatments despite being prescribed nausea prevention medication.
“The side-effects associated with chemotherapy are some of the primary causes of treatment discontinuation, so improving the control of nausea and vomiting can not only improve the quality of life of patients, by allowing those affected by cancer to complete their treatment it can also potentially save lives,” said Philippe Lucas, Vice President of Global Patient Research and Access at Tilray (1).
The side effects of chemotherapy, such as nausea and vomiting, can be distressing and feared among patients. Chief investigator, Peter Grimison, medical oncologist at Chris O’Brien Lifehouse and Associate Professor at the University of Sydney was excited by the data seen in the study. “These encouraging results indicate medicinal cannabis can help improve quality of life for chemotherapy patients,” said Grimison (1).
Although some side effects from chemotherapy were reduced others—including sedation, dizziness, and drowsiness—were still rated from moderate to severe in about one third of individuals using medicinal cannabis, but researchers considered these symptoms manageable.
“The trial will now move to a larger phase to determine with much more certainty how effective medicinal cannabis is and whether it should be considered for use in routine cancer care,” said Grimison. With these enlightening results, the next phase of the trial is continuing forward and will be recruiting another 170 participants.