TEL AVIV, Israel, March 20, 2018 /PRNewswire/ -- Therapix
Biosciences Ltd. (NASDAQ: TRPX) ("Therapix" or the "Company"), a
biopharmaceutical company focused on discovering, developing, and
commercializing novel therapeutics from its proprietary cannabinoid
product platform, announced today that the U.S. Food and Drug
Administration (FDA) has cleared its Investigational New Drug
application (IND) for THX-110 in the treatment of Chronic Low Back
Pain. Therapix expects to commence a Phase IIa clinical trial in
the second quarter of 2018.
"We believe that the clearance of this IND by the FDA is a
significant milestone for Therapix and for its platform technology
THX-110 and for patients suffering from chronic low back pain for
whom existing medicines often do not provide adequate relief,"
stated Adi Zuloff-Shani, Ph.D, Therapix's Chief Technology Officer.
"Pain represents an epidemic that is mirrored by the large and
growing opioid crisis, which is having an extreme cost in terms of
human lives. However, utilizing the power of the 'entourage
effect,' which we have previously observed in our proprietary
compound in other indications, may allow us to provide a
potentially safe and efficacious treatment for chronic low back
pain."
The chairman and co-founder of Comprehensive Pain Specialists
("CPS"), Dr. Peter Kroll, one of the
nation's largest chain of pain clinics stated, "Our challenge for
us as pain specialists is to effectively address the complex issues
facing the chronic pain population without perpetuating the opioid
crisis. Having opiate-sparing technologies such as this compound
for low back pain, one of the conditions we treat most frequently,
could potentially mean fewer costly procedures and could avoid the
reliance upon high-risk medication protocols. I believe it is vital
to have tools like these to continue to treat patients safely and
responsibly."
The Phase IIa Clinical Trial titled "Examining the Efficacy of
THX-110 [Dronabinol (synthetic Δ9-tetrahydracannabinol) and
Palmitoylethanolamide (PEA)] for Chronic Low Back Pain" 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 6 weeks with an additional 2 weeks
follow up after the last study treatment. Approximately 20 subjects
are expected to participate and receive the drug in the context of
the Clinical Trial at the Comprehensive Research Institute (CRI) in
Hendersonville, TN, U.S.A. The
primary endpoint of the Clinical Trial is to prove the safety,
tolerance and efficacy of THX-110 in the treatment of adult
patients suffering from chronic low back pain, with efficacy
measured by the improvement of quality of life outcomes. In
addition to chronic low back pain, Therapix is conducting a
clinical development program for THX-110 in the treatment of
Tourette syndrome (TS) and Obstructive Sleep Apnea (OSA).
Ascher Shmulewitz, M.D, Ph.D,
Therapix Chairman and interim CEO of Therapix said: "Despite all
efforts to reduce the suffering of chronic pain patients, the
pharmaceutical industry has had limited success in treating some of
the conditions, especially in situations that may be related to
endocannaboid deficiency.
"The endocannabinoid system is involved in a host of homeostatic
and physiologic functions, including modulation of pain and
inflammation. Cannabinoids that act as ligands of the
endocannabinoid system exert significant effects in various chronic
pain conditions. We believe that the use of THX-110 may be a
promising treatment in the management of chronic pain."
About Therapix Biosciences:
Therapix Biosciences Ltd. is a specialty clinical-stage
pharmaceutical company led by an experienced team of senior
executives and scientists. Our focus is creating and enhancing a
portfolio of technologies and assets based on cannabinoid
pharmaceuticals. With this focus, the company is currently engaged
in the following drug development programs based on repurposing an
FDA-approved synthetic cannabinoid (dronabinol): THX-110 for the
treatment of Tourette syndrome (TS), for the treatment of
Obstructive Sleep Apnea (OSA), and the treatment of Pain; THX-130
for the treatment of Mild Cognitive Impairment (MCI) and Traumatic
Brain Injury (TBI); and THX-150 for the treatment of infectious
diseases. Please visit our website for more information
at www.therapixbio.com.
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 Annual Report
on Form 20-F filed with the Securities and Exchange Commission
(SEC) on May 1, 2017 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.
Investor Contact
oz@therapixbio.com
Media Contact
Sydney Masters
Sydney@MastersMallory.com
M: 917-584-8385 P: 212-987-6804
Tel:
+972-3-6167055
Fax: +972-3-61670564
Ariel Sharon St. Hashahar Tower 16Fl.
Givatayim 5320047,
ISRAEL
info@therapixbio.com
View original
content:http://www.prnewswire.com/news-releases/therapix-biosciences-announces-fda-clearance-of-investigational-new-drug-ind-for-phase-iia-clinical-trial-of-thx-110-in-the-treatment-of-chronic-low-back-pain-300616646.html
SOURCE Therapix Biosciences Ltd