TEL AVIV, Israel, Sept. 27, 2017 /PRNewswire/ -- Therapix
Biosciences Ltd. (Nasdaq: TRPX) ("Therapix" or the "Company"), a
specialty, clinical-stage pharmaceutical company focusing on the
development of cannabinoid-based drugs, today announced new
pre-clinical data generated in the Company's development program
for the treatment of Mild Cognitive Impairment, or MCI. Therapix's
proprietary ultra-low dose tetrahydrocannabinol ("THC") drug
candidate ("THX-ULD01") significantly reversed age-related
cognitive impairment in old mice (p≤0.01). The pre-clinical animal
study was designed and conducted by Professor Yosef Sarne of the Sackler Faculty of Medicine
at Tel Aviv University.
"The data from this pre-clinical animal study suggest that
extremely low doses of THC, which are devoid of any psychotropic
effect and do not induce desensitization, could potentially provide
a safe and effective treatment for cognitive decline in aging
humans," remarked Professor Sarne.
In the study, old female mice (24-month-old) were injected once
with 0.002 mg/kg of THC, which is 3-4 orders of magnitudes lower
than doses that induce the conventional cannabinoid effects in
mice. These mice performed significantly better than
vehicle-treated old mice, and performed similarly to naive young
mice aged two months, in six different behavioral assays that
measured various aspects of memory and learning. The beneficial
effect of THC lasted for at least seven weeks. Professor Sarne
added, "the model demonstrated a relatively long-lasting increase
in neuroprotection and neuroplasticity, as well as a larger volume
and higher tissue density in various regions of the brain of
THC-treated old mice as measured by MRI."
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix,
stated, "This promising data obtained by Professor Sarne and his
team further demonstrate the clinical and commercial potential of
THX-ULD01 for the treatment of MCI. Based on the discovery of
significantly improved therapeutic impact at ultra-low doses (ULD)
of THC, it is our continued belief that THX-ULD01 has the potential
to fulfill the growing unmet medical need in MCI." Dr. Zuloff-Shani
continued, "Further, this data echoes similar findings in
pre-clinical models that demonstrate the neuroprotective role of
ULD THC, which are expected to be followed by human trials for this
potential first-in-class therapy."
Professor Sarne's scientific publication detailing these
findings, titled, "Reversal of age-related cognitive impairments in
mice by an extremely low dose of tetrahydrocannabinol (THC)," was
recently accepted for publication in Neurobiology of Aging,
and will be presented at the International Association for
Cannabinoid Medicines' (IACM) 9th Conference on
Cannabinoids in Medicine being held September 29-30, 2017 in Cologne, Germany.
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 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
the treatment of Tourette 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-ULD01:
THX-ULD01 is a proprietary, new, ultra-low dose formulation of
dronabinol, or synthetically-conjugated THC, which is intended to
provide a treatment for Mild Cognitive Impairment (MCI). TXH-ULD01
is being developed to be delivered either by sublingual or nasal
administration. Recent pre-clinical animal studies have found that
an ultra-low dose of THC could potentially protect the brain from
long-term cognitive impairment, which may be caused by lack of
oxygen supply, seizures or use of drugs. Certain pre-clinical
studies also suggest that ultra-low doses of THC cause animals to
improve performance in behavioral tests that measure learning and
memory.
About Mild Cognitive Impairment:
Mild cognitive impairment ("MCI") is an intermediate stage
between the expected cognitive decline of normal aging and the
more-serious decline of dementia. It can involve problems with
memory, language, thinking and judgment that are greater than
normal age-related changes. MCI causes cognitive changes that are
serious enough to be noticed by the individuals experiencing them,
or to other people, but the changes are not severe enough to
interfere with daily life or independent function. People with MCI,
especially those involving memory problems, are more likely to
develop Alzheimer's disease or other dementias than people without
MCI. MCI is a widespread condition that increases with age at a
rate of 10% among 70–79-year-olds and 25% among 80–89-year-olds.
There is currently no FDA approved treatment for MCI.
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. Such
forward-looking statements used in this press release include,
among other things, references to the clinical and commercial
potential of THX-ULD01 for the treatment of MCI. Actual results
could differ from those projected in any forward-looking statements
due to numerous factors. Such factors include, among others, our
ability to raise the additional funding needed to continue to
pursue our business and product development plans, the inherent
uncertainties associated with developing new products or
technologies, our ability to obtain regulatory approval for our
product candidates, our ability to commercialize our product
candidates, competition in the industry in which we operate and
overall market conditions. 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