Therapix Biosciences announces enrollment of the first patient for clinical trial at Yale University for treating Tourette’s syndrome using cannabinoid-based drug
TEL AVIV, Israel, January 4, 2017 /PRNewswire/ —
The Company respectfully updates, that it was informed that on December 23, 2016, the first subject was enrolled into the proof-of-concept phase IIa clinical trial of the drug developed by the Company (THX-TS01)¹ for treatment of neurological disorders, initially focusing on Tourette’s syndrome, which is based on the Company’s licensed entourage technology (the “Clinical Trial” and the “Drug”, respectively). The Clinical Trial is financed by the Company and is conducted in the context of an iIND application² that was filed with the FDA by a team of investigators from Yale University in the U.S.³ The foregoing update follows previous reports of the Company regarding its preparations towards the performance of the Clinical Trial.
The Clinical Trial is a single-arm, open-label trial, in which each subject receives one daily treatment of the drug via oral administration and is followed-up for a period of 12 weeks (approx. 3 months). Around 18 subject are expected to participate and receive the drug in the context of the Clinical Trial at the medical center of Yale University in the U.S. The primary endpoint of the Clinical Trial is to prove the safety, tolerance and efficacy of the Drug’s treatment, and to assess its performance in adult patients suffering from symptoms of Tourette’s syndrome, as measured by the Yale Global Tic Severity Scale Total Tic Score, a customary index for assessing symptom severity. In addition, inter alia, the influence of the medicinal treatment on the severity of additional mental disorders that often accompany Tourette’s syndrome, such as OCD and ADHD, will also be tested.
The Clinical Trial, the commencement of which was one of the Company’s targets for 2016, began on time as planned. At this stage, its date of completion cannot be estimated (which mainly depends on the enrollment rate of the additional subjects). The Company will continue to update of any material development and information it will receive on the course of the Clinical Trial and its results.
¹ The drug is a combination between the THC and PEA compounds.
² (Investigator initiated) Investigational New Drug – an application for a drug examination proceeding by the FDA, for the purpose of performing clinical trials in humans, that was filed and is being handled by investigators at the University, with the Company’s financing.
³ The two primary investigators of the Clinical Trial also hold office as members of the Company’s SAB.
Original press release: http://www.prnewswire.com/news-releases/therapix-biosciences-announces-enrollment-of-the-first-patient-for-clinical-trial-at-yale-university-for-treating-tourettes-syndrome-using-cannabinoid-based-drug-609645765.html
