Tilray has imported medical cannabis into the US from Canada in support of a new clinical trial.
The trial will test the safety and efficacy of medical cannabis in treating breast cancer patients suffering from taxane-induced peripheral neuropathy (TIPN) secondary to treatment with paclitaxel or docetaxel.
Tilray’s clinical trial on cannabis is the first human study testing the efficiency of medical cannabis to treat TIPN.
The first-of-its-kind trial will test the efficacy of cannabis as a treatment for TIPN, which affects approximately 67% of women undergoing breast cancer treatment.
Tilray Global Patient Research and Access vice-president Philippe Lucas said: “Tilray is committed to advancing cannabis research through its support of clinical trials around the world as we continue to enhance our understanding of the potential benefits of medical cannabis.”
The study is led by Columbia University Irving Medical Center (CUIMC) Psychiatry professor Diana Martinez and CUIMC neurobiology professor Margaret Haney.
Tilray noted that the clinical trial will be a randomised, placebo-controlled study. Half of the subjects will receive an investigational product containing a combination of THC and CBD, while the other half of the participants will receive a product with no active cannabinoids.
The trial will see participants being treated twice daily for eight weeks. Patient recruitment is underway for the study.
Margaret Haney said: “There is a critical need for randomised controlled clinical studies to test the efficacy of cannabis in patients.
“There is exciting preclinical evidence showing that THC and CBD significantly reduce TIPN, and our study will be the first to test this in a well-powered clinical trial.”
Despite the lack of effective treatment for TIPN, studies evaluating the use of medical cannabis to treat paclitaxel-induced neuropathic pain in mice have shown positive results.
In September 2016, Tilray and the University of British Columbia began patient enrolment in Canada’s first Phase II clinical trial of medical cannabis to treat post-traumatic stress disorder (PTSD).