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First-of-its-kind trial will test the efficacy of cannabis as a treatment for taxane-induced peripheral neuropathy, which affects 67 percent of women undergoing breast cancer treatment
Tilray, Inc. (NASDAQ: TLRY), a global pioneer in cannabis research, cultivation, production and distribution, today announced it has successfully imported medical cannabis into the United States from Canada in support of a new clinical trial. The study will test the efficacy of medical cannabis in treating patients with breast cancer who are suffering from taxane-induced peripheral neuropathy (TIPN) secondary to treatment with paclitaxel or docetaxel. This clinical trial is the first human study testing the effectiveness of medical cannabis to treat TIPN.
“We’re excited to support this groundbreaking, first-of-its-kind trial seeking to find a new treatment option for TIPN,” says Philippe Lucas, Tilray’s Vice President of Global Patient Research and Access. “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.”
Led by Diana Martinez, M.D., Professor of Psychiatry at Columbia University Irving Medical Center (CUIMC), and Margaret Haney, Ph.D., Professor of Neurobiology (in Psychiatry) at CUIMC, the clinical trial will be a randomized placebo-controlled study in which half of participants will receive an investigational product containing a combination of THC and CBD and the other half will receive a product with no active cannabinoids. Participants will be treated twice daily for eight weeks. Researchers are currently recruiting patients for the study.
According to Dr. Haney, “There is a critical need for randomized 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.”
TIPN affects more than 67 percent of women undergoing breast cancer treatment. As a result of TIPN, some patients must shorten their course of treatment and are unable to reap the full benefits of chemotherapy. Although currently there is a lack of effective treatment for TIPN, studies assessing the use of medical cannabis to treat paclitaxel-induced neuropathic pain in mice have demonstrated positive results.
Tilray has supported medical trials on a global level across Canada, the United States and Australia, studying the efficacy of medical cannabis as treatment for indications including pediatric epilepsy, essential tremor, post-traumatic stress disorder and alcohol use disorder.
Tilray is a global pioneer in the research, cultivation, production and distribution of cannabis and cannabinoids currently serving tens of thousands of patients and consumers in 13 countries spanning five continents.
Cautionary note regarding forward-looking statements:
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements or forward-looking-information in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking statements are not a guarantee of future performance, future action or any particular result to clinical trials and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment and future approvals and permits. Actual results, performance or achievement could differ materially from that expressed in, or implied by, any forward-looking statements in this press release, and, accordingly, you should not place undue reliance on any such forward-looking statements and they are not guarantees of future results. Please see the heading “Risk Factors” in Tilray’s Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission and Canadian securities regulators on August 13, 2019, assumptions, uncertainties and other factors that may cause actual future results or anticipated events to differ materially from those expressed or implied in any forward-looking statements. Tilray does not undertake and specifically declines any obligation to update any forward-looking statements that are included herein, except in accordance with applicable securities laws.
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