Proposed B.C. Cancer cannabis trial beset by delays
Credit to Author: Pamela Fayerman| Date: Tue, 29 Oct 2019 23:49:49 +0000
B.C. Cancer is still awaiting approval for a national clinical trial that aims to find out if cannabis extracts offer symptom relief.
It’s been 10 months since B.C. Cancer announced the trial to explore whether cannabis properties reduce cancer-related symptoms including pain, sleep disturbance, anxiety and nausea. But regulatory and other issues have stalled it.
Recruiting of 150 patients in Vancouver, Abbotsford, Prince George, Victoria, Calgary, Winnipeg, Ottawa, Kingston, and Toronto for the 48-day trial is expected to begin, “in the best-case scenario,” by the end of the year.
Dr. Pippa Hawley, a palliative care specialist and medical director of the provincial pain and symptom management program at B.C. Cancer, is leading the trial. In January, Hawley said she expected recruitment of study participants would begin by June and that study results would be published a year later.
Hawley said she’s been frustrated by the slow pace of progress, caused by factors out of her control. For one, the company donating the organic cannabis oil product was taken over by another company just as B.C. Cancer announced its trial. Hawley said all the paperwork had to be redone — ” a good learning experience” — and then new product testing had to be done with the new owners, Aurora Cannabis Inc.
Aurora is also involved in a Hamilton study using cannabis for cancer pain control. It is still recruiting patients for that trial, according to a Health Canada website.
Hawley, who’s been providing authorizations for medical cannabis to patients for many years, said the $1 million for her randomized, double-blind, placebo-controlled study is coming from anonymous, private donors to the B.C. Cancer Foundation.
While the B.C. Cancer study is still awaiting Health Canada approval, there are numerous other cannabis studies being done in health care. One is now recruiting 100 breast cancer patients and is being called the first human trial evaluating cannabis for relief of chemotherapy-induced neuropathy. Columbia University researchers are using Vancouver Island-grown products in varying concentrations of oil in capsules.
Tilray Inc., headquartered in Nanaimo, is partnering with the New York researchers to test whether cannabis provides relief from Taxane-induced peripheral neuropathy which causes pain, numbness and tingling. Taxane is a chemotherapy drug.
Philippe Lucas, vice-president of global patient research and access for Tilray, called it a “groundbreaking, first-of-its-kind trial,” led by Dr. Diana Martinez, a professor of psychiatry and Margaret Haney, a professor of neurobiology. The eight-week study is a randomized, placebo-controlled design in which half the participants will receive a product containing a combination of THC and CBD, two active ingredients in cannabis, while the other half will get a product with no active cannabinoids.
Lucas said the New York researchers approached Tilray to supply the products for the trial. But it is only one of the numerous clinical trials Tilray is, or has been, involved in. Among others are a study on essential tremors at University of California San Diego; a study on pediatric epilepsy at the Toronto Hospital for Sick Kids; one on chemotherapy-induced nausea in Australia; and a few studies on post-traumatic stress disorder, one in the U.S. and another in B.C. which has not yet reported results.
Tilray has also supplied medicinal cannabis products for a McGill University study on chronic obstructive pulmonary disease and another study at McGill on inflammation in HIV/AIDS patients.
Lucas said it is not fast or easy to get approvals for cannabis research in the U.S.
An import permit from the Drug Enforcement Administration is needed so the substances can enter the U.S. and clear customs, he said. The Food and Drug Administration has to grant approval for the clinical trial to take place by issuing an investigational new drug number. After that, Health Canada has to issue an export permit for the U.S. trials.
Twitter: @MedicineMatters