TEL AVIV, Israel, May 8, 2017 /PRNewswire/ -- Therapix Biosciences
Ltd. (Nasdaq: TRPX) ("Therapix"), a specialty clinical stage
pharmaceutical company specializing in the development of
cannabinoid-based drugs, today announced that it entered into a
trial agreement with the Hannover Medical School to conduct a
proof-of-concept Phase II clinical study with its lead compound,
THX-TS01, for patients suffering from Tourette Syndrome.
As previously reported, this investigator initiated study, is
projected to be initiated during the third quarter of 2017, subject
to receiving necessary regulatory approvals in Germany. The study will be conducted at
Hannover Medical School in Germany
under the leadership of principal investigator, Professor
Kirsten Muller-Vahl. The study
will be a randomized, double-blind, placebo controlled cross-over
proof-of-concept Phase II clinical study to evaluate the safety,
tolerability and efficacy of up to twice daily oral THX-TS01 in
treating adults with Tourette Syndrome (the "Hannover Study").
Each subject will be randomized to receive either THX-TS01 or
placebo in a 1:1 ratio via oral administration. A total of 20
patients will be evaluated in a cross-over design. In the
first stage, the patients will be randomized to either treatment or
placebo and will be treated for a duration of 13 weeks.
Afterwards, the patients will be crossed-over and will be
treated for an additional 13 weeks; patients who initially received
placebo will receive treatment and vice versa. The primary
endpoint of the Hannover Study is to evaluate the safety, tolerance
and efficacy of THX-TS01. The primary efficacy endpoint will
be measured according to Yale Global Tic Severity Scale Total Tic
Score, a widely-accepted index for assessing symptom severity and
frequency. In addition, the effect of THX-TS01 will be
evaluated by several secondary endpoints, including additional
scales for measuring tics severity as well as other mental
disorders that often accompany Tourette Syndrome, including OCD and
ADHD.
"The therapeutic effect of THC in several CNS-related
indications has long been established and my lab at Hannover
Medical Schools feels fortunate to have been centrally involved in
that research," stated Professor Kirsten
Muller-Vahl, department of Psychiatry, Socialpsychiatry and
Psychotherapy and head of the Tourette outpatient clinic at
Hannover Medical School. Professor Muller-Vahl continued, "This
robust study that we are embarking upon with Therapix Biosciences
will assess the potential synergistic effect of THC in combination
with PEA, in what my esteemed colleague Professor Raphael Mechoulam coined the 'Entourage Effect'
many years ago. We're enthusiastic to be conducting this
study, and optimistic about its findings," concluded Professor
Muller-Vahl.
Dr. Elran Haber, Therapix's Chief Executive Officer, stated
"We're excited to embark upon the Hannover Study. Hannover
Medical School is well regarded as a center of excellence in this
area of research, and Professor Muller-Vahl is a recognized key
opinion leader in both cannabinoid-based therapeutics and Tourette
Syndrome." Dr. Haber concluded, "We're optimistic that the Hannover
Study, in conjunction with our currently ongoing study at
Yale University, will support earlier
research done with cannabinoid-based therapies and may suggest that
THX-TS01 is a safe and efficacious treatment for this highly
debilitating disease with high unmet medical need."
About Therapix Biosciences:
Therapix Biosciences Ltd. is a specialty clinical-stage
pharmaceutical company led by an experienced team of senior
executives and scientists, focused on creating and enhancing a
portfolio of technologies and assets based on cannabinoid
pharmaceuticals. With this focus, the company is currently
engaged in two internal drug development programs based on
repurposing an FDA approved synthetic cannabinoid (dronabinol):
THX-TS01 targets to the treatment of Tourette's syndrome; and
THX-ULD01 targets the high-value and under-served market of mild
cognitive impairments. Please visit our website for more
information at www.therapixbio.com.
About THX-TS01:
THX-TS01 is a combination drug candidate for the treatment of
Tourette Syndrome and it is based on two components: (1)
dronabinol, the active ingredient in an FDA approved synthetic
analog of tetrahydrocannabinol ("THC"), which is the psychoactive
molecule in the cannabis plant, and (2) Palmitoylethanolamide
("PEA"), which is an endogenous fatty acid amide that belongs to
the class of nuclear factor agonists, which are proteins that
regulate the expression of genes. The combination of THC and
PEA may induce a reaction known as the "entourage effect."
The basic tenet of the entourage effect is that cannabinoids
work together, or possess synergy, and affect the body in a
mechanism similar to the body's own cannabinoid system, which is a
group of molecules and receptors in the brain that mediates the
psychoactive effects of cannabis. This entourage effect may
account for the pharmacological actions of PEA. Based on an
activity enhancement of other physiological compounds, PEA may
indirectly stimulate the cannabinoid receptors by potentiating
their affinity for a receptor or by inhibiting their metabolic
degradation, and by doing so, may increase the uptake of
cannabinoid compounds, such as THC. Thus, it is speculated
that the presence of the PEA molecule likely increases the efficacy
of orally administered THC, while reducing the required dosage and
decreasing associated deleterious adverse events.
About Tourette Syndrome:
Tourette Syndrome is a neuropsychiatric disorder, characterized
by physical (motor) tics and vocal (phonic) tics. Motor or
phonic tics are sudden, brief, intermittent, involuntary or
semi-voluntary movements or sounds, respectively. They
typically consist of brief, coordinated, repetitive movements,
gestures, or utterances that mimic fragments of normal behavior.
The tics associated with Tourette Syndrome can have
significant effects on the academic and social development of
children as well as affecting their overall self-esteem and mental
health. Although the majority of children experience a
decrease in their tics during adolescence, the worst symptoms are
usually experienced by adults with intractable Tourette
Syndrome.
Forward-Looking Statements:
This press release contains forward-looking statements about the
Company's expectations, beliefs, and intentions. Forward-looking
statements can be identified by the use of forward-looking words
such as "believe", "expect", "intend", "plan", "may", "should",
"could", "might", "seek", "target", "will", "project", "forecast",
"continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these
statements do not relate strictly to historical matters. For
example, forward-looking statements are used in this press release
when we discuss our plans to conduct clinical studies, the design
of such studies and whether they will support earlier research done
with cannabinoid-based therapies and suggest that THX-TS01 is a
safe and efficacious treatment. In addition, historic results of
scientific research and clinical trials do not guarantee that the
conclusions of future research or trials will suggest identical or
even similar conclusions or that historic results referred to in
this press release would not be interpreted differently in light of
additional research and clinical and preclinical trial results.
These forward-looking statements involve certain risks and
uncertainties, including, among others, risks that could cause the
Company's results to differ materially from those expected by
Company management or otherwise described in or implied by the
statements in this press release. Any forward-looking statement in
this press release speaks only as of the date of this press
release. The Company undertakes no obligation to publicly update or
review any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by any applicable securities laws. More detailed
information about the risks and uncertainties affecting the Company
is contained under the heading "Risk Factors" in Therapix
Biosciences Ltd.'s annual report on Form 20-F dated May 1, 2017 filed with the SEC, which is
available on the SEC's website, www.sec.gov.
For further information: Investor Contact:
Josh Blacher, CFO, Therapix
Biosciences, josh@therapixbio.com
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SOURCE Therapix Biosciences Ltd