TEL AVIV, Israel, January 4, 2017 /PRNewswire/ --
Therapix Biosciences, (OTCQB: THXBY) (TASE: THXBY.TA), the pharma company specializing in the development and commercialization of cannabinoid-based, 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) 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 application that was filed with the FDA by a team of investigators from Yale University in the U.S.  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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Therapix's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Therapix could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the Company's plans with respect to its clinical trials and its intent to report material developments and information regarding such trials. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Therapix Biosciences Ltd.'s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, Therapix disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
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.
For further details, Goldfinger Communications, Irit Yosilevitch, +972-052-3887799
SOURCE Therapix Biosciences