Therapix Biosciences Ltd (NASDAQ: TRPX) Breaking News -
November 10, 2017
Therapix Biosciences Plans Preclinical Study to Evaluate Opioid-Sparing Effects
of Two Innovative Synthetic Cannabinoids
Executes Material Transfer Agreement with Yissum for Two
Synthetic Agonists Synthesized by Professor Raphael Mechoulam
TEL AVIV, Israel, - Nov. 10, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty clinical-stage pharmaceutical company specializing in the
development of cannabinoid-based treatments, executed a non-exclusive material
transfer agreement with Yissum, the technology transfer company of The Hebrew
University of Jerusalem, for two synthetic cannabinoids synthesized by Raphael
Mechoulam, Ph.D., Professor of medicinal chemistry at the university and
Chairman of the Therapix Scientific Advisory Board. Therapix plans to initiate a
preclinical study during the fourth quarter to evaluate the opioid-sparing
effect of these compounds in a rat model.
The opioid overuse epidemic in the United States was recently declared a public
health emergency by President Donald Trump. According to Medical Care,
prescription opioid overdose, abuse and dependence carries high costs for
society with an estimated total economic burden of $78.5 billion in the United
States alone. Nevertheless, for immediate relief of moderate-to-severe acute as
well as chronic pain, opioids are frequently the treatment of choice due to
their rapid onset and efficacy. However, due to their addictive nature and
deleterious adverse events that may lead to lethal outcomes, there is a need to
significantly reduce their effective therapeutic dose.
Dr. Adi Zuloff-Shani, Chief Technology Officer at Therapix, said, “To address
the opioid issue, Therapix is collaborating w ith
Professor Mechoulam to develop a therapy of innovative cannabinoids and opioids.
The study builds upon the innovative work of Professor Mechoulam and seeks to
reduce the use of opioids by combining them with proprietary cannabinoid
molecules to alleviate pain.”
“Based on our research surrounding the effects of the endocannabinoid system and
how cannabinoids can play a role in pain relief, our group of research
scientists has synthesized cannabinoids with improved binding affinity and
target specificity, which do not cause the therapeutically undesirable cannabis
psychoactivity,” stated Professor Mechoulam. “In view of their parallel actions
in pain, cannabinoids and opioids together may allow the development of a novel
therapy that could exhibit a synergistic effect that reduces the therapeutic
effective dose of opioids.”
Josh Blacher, Chief Financial Officer at Therapix, said, “We are privileged to
be working with Professor Mechoulam and the Hebrew University in paving the way
forward to a potential new therapeutic that may one day help to address this
deadly social and medical crisis.”
About Therapix Biosciences Ltd.:
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 and THX-120 for the treatment of
Tourette syndrome (TS) and Obstructive Sleep Apnea (OSA); 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.
About Yissum:
Yissum is the technology transfer company of The Hebrew University of Jerusalem.
Founded in 1964, it is the third company of its kind to be established, and
serves as a bridge between cutting-edge academic research and a global community
of entrepreneurs, investors, and industry. Yissum’s mission is to benefit
society by converting extraordinary innovations and transformational
technologies into commercial solutions that address our most urgent global
challenges. Yissum has registered over 10,000 patents covering 2,800 inventions;
licensed over 900 technologies and has spun out more than 125 companies.
Yissum’s business partners span the globe and include companies such as Boston
Scientific, Google, ICL, Intel , Johnson & Johnson, Merck, Microsoft, Novartis
and many more. For further information please visit www.yissum.co.il
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 the Company’s product candidates.
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
Therapix Biosciences Ltd.
For further information: +972-3-616-7055
Media Contact:
Susan Forman, DGI
+1-212-825-3210
SOURCE: Therapix Biosciences Ltd.
Cure Pharmaceutical Enters
Into Product Development Agreement with Therapix Biosciences To Develop
Cannabinoid-Based Product For Sleep Disorders
CURE to Manufacture Therapix Proprietary Entourage
Formulation (Dronabinol and PEA)-Based Product Using Proprietary CureFilm™
Technology
TEL AVIV, Israel, - Nov. 7, 2017 - /PRNewswire/ -- Cure Pharmaceutical (OTCQB:CURR),
(“CURE”), a leading disruptive drug delivery technology announced today that it
has entered into a product development agreement with Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty, clinical-stage pharmaceutical company focusing on the development
of cannabinoid-based treatments. The joint effort will formulate a proprietary
cannabinoid-based product on CURE’s patented, multilayer oral thin film (OTF),
CureFilm™, for the treatment of a wide range of sleep disorders.
This agreement is an extension of the recently announced partnership between
CURE, Therapix and Israel’s Assuta Medical Centers, Ltd. to develop
first-in-class therapeutic products in the fields of personalized medicine and
cannabinoids.
Under terms of the product development agreement, CURE will develop a
formulation that combines 2.5mg of dronabinol, a synthetic form of the key
therapeutic cannabinoid endogenous to cannabis, 9-tetrahydrocannabinol (THC),
and 200mg of palmitoylethanolamide (PEA) on its OTF technology. This formulation
constitutes the advancement of Therapix’s clinical
development program focusing on sleep disorders, as recently announced in the
agreement between Therapix and Assuta Medical Center in the initiation of a
Phase IIa clinical trial in obstructive sleep apnea.
Sleep apnea is a very large, underserved market with no available pharmaceutical
treatments. An estimated 18 million patients suffer from this disorder in the
U.S. The most common method of treatment uses a medical device called constant
positive airway pressure (CPAP). While CPAP therapy can be effective in reducing
sleep apnea, about half of patients on CPAP are non-adherent. This suggests a
clear market need for a safe, effective pharmaceutical treatment for sleep apnea
and other sleep disorders.
“We are enthusiastic about this next phase in our strategic partnership with
Therapix. This product development agreement serves as testament that we are
delivering on the goal we set forth when we first partnered in July to pool our
expertise and resources to develop new products,” said CEO of CURE Rob Davidson.
“Our main goal at CURE is to improve people’s lives by redefining how
medications are delivered, and sleep disorders is a medical indication with high
unmet need that I think we can significantly impact.”
Repurposing the FDA-approved dronabinol using Therapix’s proprietary combination
that exhibits the “entourage effect” is key to improving patient compliance and
reducing unwanted side-effects. Dr. Ascher Shmulewitz, Executive Chairman of
Therapix, added, “Our goal at Therapix is to provide an optimized therapy for
the treatment of a host of unmet medical needs, including sleep disorders, while
reducing the dependence on more harmful drugs."
Cure Pharmaceuticals has already completed the feasibility study for this new
product and will begin proof of concept in the coming weeks, with the overall
goal of providing a deeper un-interrupted sleep for the 40 million people who
suffer from sleep related disorders in the United States. This, in addition to
the way CURE’s CureFilm™ OTF technology offers a better option for the 40% of
Americans who can’t swallow pills, improved bioavailability and fewer side
effects, demonstrates CURE’s commitment to creating a world in which all people
can take their medications easily and effectively.
About CURE Pharmaceutical
CURE Pharmaceutical is a fully integrated life science company committed to
improving drug efficacy, safety and the patient experience through its
proprietary drug dosage forms and delivery systems. CURE has an industry leading
full service cGMP manufacturing facility and is a preeminent developer and
manufacturer of a patented and proprietary delivery system (CureFilm™), the most
advanced oral thin film on the market today. CURE has developed an array of
products in cutting-edge delivery platforms and partners with leading
pharmaceutical companies. CURE has positioned itself to advance numerous
therapeutic categories, including the pharmaceutical cannabis sector with
partnerships in the U.S., Canada, Israel and Germany, among other markets. The
Company’s mission is to improve people’s lives by redefining how medicines are
delivered and experienced.
For more information about CURE Pharmaceutical, please visit its website at
www.curepharmaceutical.com.
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 two internal drug development programs based on repurposing an FDA approved
synthetic cannabinoid (dronabinol): THX-110 targets the treatment of the
symptoms of Tourette Syndrome; and THX-130 targets the high-value and
under-served market of mild cognitive impairments and Traumatic Brain Injury (TBI).
Please visit our website for more information at www.therapixbio.com.
Forward-looking statement
This press release contains forward-looking statements, which are subject to
risks and uncertainties. All statements, other than statements of fact,
including those statements with respect to the Company's business development,
are forward-looking statements. Forward-looking statements speak only as of the
date made and are not guarantees of future performance. We undertake no
obligation to publicly update or revise any forward-looking statements.
CURE Public Relations Contact: Andrew Hard
Chief Executive Officer
CMW Media
andrew.hard@cmwmedia.com
P. +1888 829-0070
www.cmwmedia.com
Therapix Investor Contact:
Josh Blacher
Chief Financial Officer
Therapix Biosciences
josh@therapixbio.com
P. +972-3-616-7055
Source: CURE Pharmaceutical; Therapix Biosciences Ltd.
Therapix to Present at and
Attend Investor Conferences in London
Presentation at the Biotech & Money Inv€$tival Showcase to
Be Held on November 14, 2017 at 4:15PM CET
TEL AVIV, Israel, - Nov. 2, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty, clinical-stage pharmaceutical company focusing on the development
of cannabinoid-based treatments, will be presenting at the Biotech & Money Inv€$tival
Showcase on November 14, 2017 and attending the Jefferies Healthcare Conferences
on November 15-16, 2017, in London. In exclusive partnership with Jefferies LLC,
the Inv€$tival Showcase spans four tracks and will feature the most exciting
companies across seven key sub-sectors within life sciences.
http://mma.prnewswire.com/media/507393/Therapix_Biosciences_Logo.jpg
Event: Biotech & Money Inv€$tival Showcase
Date: Tuesday, November 14, 2017
Presentation Time: 4:15PM CET
Location: The Hilton Waldorf, Aldwych, London
Event: Jefferies Healthcare Conference
Date: November 15-16, 2017
Location: The Hilton Waldorf, Aldwych, London
Mr. Blacher's presentation at the Biotech & Money Inv€$tival Showcase on
November 14 will be webcast live and will remain available for 90 days following
the presentation. To access the webcast, please visit the Events tab of the
Investor Relations section of the Therapix website at www.therapixbio.com.
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 two internal drug development programs based on repurposing an FDA approved
synthetic cannabinoid (dronabinol): THX-110 targets the treatment of the
symptoms of Tourette syndrome; and THX-130 targets the high-value and
under-served market of mild cognitive impairments and Traumatic Brain Injury (TBI).
Please visit our website for more information at www.therapixbio.com.
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-OSA01 for the treatment of
Obstructive Sleep Apnea. 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
Therapix Biosciences Ltd.
For further information: +972-3-616-7055
Media Contact:
Susan Forman
DGI
+1-212-825-3210
SOURCE Therapix Biosciences Ltd.
Therapix Biosciences' Board
Chairman, Ascher Shmulewitz, Appointed as Interim Chief Executive Officer
TEL AVIV, Israel, - Nov. 2, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty clinical-stage pharmaceutical company developing cannabinoid-based
treatments, has appointed Ascher Shmulewitz, M.D., Ph.D., the Company's Chairman
of the Board of Directors, to the role of Interim Chief Executive Officer (CEO),
effective immediately.
http://mma.prnewswire.com/media/507393/Therapix_Biosciences_Logo.jpg
The Company's Board of Directors and Audit Committee, as confirmed by
yesterday's shareholder approval at its annual general meeting of shareholders,
determined that authorizing Dr. Shmulewitz to serve as Interim CEO is currently
the most
effective leadership structure. As one of Therapix's key founding investors, Dr.
Shmulewitz brings significant experience in cannabinoid-based medicine and has a
well-established track record leading biopharmaceutical companies.
Dr. Shmulewitz commented, "I am pleased by the decision of the Board and
shareholders to appoint me as Interim CEO and I look forward to the
opportunities ahead. I believe that this Company's strong portfolio of
therapeutic candidates for unmet needs is promising."
Dr. Shmulewitz has served as Chairman of Therapix since January 2014 and on the
Company's Board of Directors since February 2013. He founded and invested in
more than two dozen life science companies including NeoVision Corp., Labcoat
Medical Ltd., Arteria Corp, Circulation Inc. and X-Cardia Inc., and led many of
these companies to successful exits, including through merger and acquisition
transactions with large life sciences companies.
Dr. Shmulewitz has vast venture capital experience investing in and managing
dozens of companies and ventures. In 1995, he co-founded San Francisco Science
and the Incumed Group, which provide seed funding. He is the founder of
Medgenesis Partners Ltd., an Israeli private investment firm that has invested
in more than a dozen ventures. He also previously held senior executive
positions at Advanced Technology Laboratories Inc. from 1988 to 1992. Dr.
Shmulewitz received an M.D. from The Technion American Medical School and a
Ph.D. in engineering from Tel Aviv University in Israel.
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 two internal drug development programs based on repurposing an FDA approved
synthetic cannabinoid (dronabinol): THX-110 targets the treatment of the
symptoms of Tourette syndrome; and THX-130 targets the high-value and
under-served market of mild cognitive impairments and Traumatic Brain Injury (TBI).
Please visit our website for more information at www.therapixbio.com.
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-OSA01 for the treatment of
Obstructive Sleep Apnea. 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
Therapix Biosciences Ltd.
For further information: +972-3-616-7055
Media Contact:
Susan Forman, DGI
+1-212-825-3210
SOURCE Therapix Biosciences Ltd
Therapix Biosciences Initiates
Non-clinical Studies for its Antibacterial Program in Collaboration With the
Weizmann Institute of Science and Tel Aviv Sourasky Medical Center
- Expands Pipeline of Potential Indications Using Cannabinoid Platform -
TEL AVIV, Israel, - October 30, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty, clinical-stage pharmaceutical company focusing on the development
of cannabinoid-based treatments, has initiated non-clinical studies to evaluate
the efficacy of its proprietary compound THX-150 in collaboration with the
Weizmann Institute of Science and the Tel Aviv Sourasky Medical Center. THX-150
is a pharmaceutical composition of dronabinol (synthetic
∆9-tetrahydracannabinol) and/or palmitoylethanolamide (PEA) along with a
selected antibacterial agent that the Company believes may possess synergies.
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix, said, "We believe
our proprietary cannabinoid-based candidate therapy, which employs an
alternative mechanism of action, provides a possible solution to the peril of
antibiotic drug resistance. In our preliminary studies, we observed that
cannabinoids increase the potency and decrease the minimal
required therapeutic dosages of antibacterial agents, thus potentially
minimizing the development of drug resistance and reducing side effects from
antibiotic treatment."
Professor Itamar Shalit, M.D., Associate Professor in Pediatrics at Tel Aviv
University and a leading authority on infectious diseases, said, "In our earlier
non-clinical collaboration with Therapix, THX-150 was effective in eradicating
resistant bacterial strains significantly better to what was observed in the
bacterial controls treated only with antibiotics. In this particular case, we
evaluated our technology's utility in acting synergistically with gentamicin, a
well-accepted antibacterial therapy, and reducing its dose requirement for
eradicating certain bacteria including resistant strains. We were encouraged by
the early results and believe there could be broader applications within the
antimicrobial sphere."
Dr. Berta Strulovici, Ph.D., Director of the National Center for Personalized
Medicine in Israel said, "This collaboration between Therapix Biosciences and
the Israel National Institute for Personalized Medicine (INCPM), at the Weizmann
Institute, uses top-of-the-line genomic techniques and will accelerate the
elucidation of the mechanism of action."
"There is a dire need for new antibacterials in the clinic," said Professor
Rotem Sorek, a professor of microbiology at the Weizmann Institute of Science,
who is one of the leaders in the CRISPR field. "An antibacterial drug with a new
mechanism of action would be revolutionary."
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 two internal drug development programs based on repurposing an FDA approved
synthetic cannabinoid (dronabinol): THX-110 targets the treatment of the
symptoms of Tourette Syndrome; and THX-130 targets the high-value and
under-served market of mild cognitive impairments and Traumatic Brain Injury (TBI).
Please visit our website for more information at www.therapixbio.com.
About THX-150:
THX-150 is a drug candidate intended for the treatment of infectious diseases.
It consists of Dronabinol (synthetic ∆9-tetrahydracannabinol) and/or
Palmitoylethanolamide (PEA) and selected antibacterial agent and possesses
antimicrobial synergy potential. Dronabinol is the active ingredient in an FDA
approved synthetic analog of tetrahydrocannabinol ("THC"), which is the
psychoactive molecule in the cannabis plant, and 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.
Antibiotics are a type of antimicrobial drug used in the treatment and
prevention of bacterial infection.
About Antimicrobial Resistance:
According to the World Health Organization, antimicrobial resistance, classified
as a 'serious threat', occurs when microorganisms are exposed to antimicrobial
drugs. As a result, medicines become ineffective and infections persist,
increasing the risk of spread. New resistance mechanisms are emerging globally,
threatening the ability to treat common infectious diseases. Without effective
antimicrobials for prevention and treatment of infections, medical procedures
such as organ transplantation, cancer chemotherapy, diabetes management and
major surgery are jeopardized. Antimicrobial resistance increases the cost of
healthcare with lengthier stays in hospitals and more intensive care required.
According to the U.S. Centers for Disease Control and Prevention in conjunction
with research conducted at Tufts University, antibiotic-resistant infections add
considerable and avoidable costs to the already overburdened U.S. healthcare
system. In most cases, antibiotic-resistant infections require prolonged and/or
costlier treatments, extend hospital stays, necessitate additional doctor visits
and healthcare use, and result in greater disability and death compared with
infections that are easily treatable with antibiotics.
About Weizmann Institute of Science:
The Weizmann Institute of Science is one of the world's leading
multidisciplinary basic research institutions in the natural and exact sciences.
The Weizmann Institute has a long history of investigation and discovery rooted
in a mission of advancing science for the benefit of humanity. In parallel, it
educates a substantial proportion of Israel's scientific leadership and advances
science literacy in schools and among the public.
About the National Center for Personalized Medicine in Israel:
The Center will be applying novel technologies in genomics, proteomics and High
Throughput Screening to enable and advance Personalized Medicine in Israel.
About Tel Aviv Sourasky Medical Center:
Tel Aviv Sourasky Medical Center (Ichilov) is the largest acute care facility in
Israel, treating about 400,000 patients and hosting 1.8 million patient visits
per year. A 1500-bed world-class governmental academic medical center, Tel Aviv
Sourasky Medical Center serves a population of one million people, including
residents from the greater Tel Aviv area and visitors to the metropolis.
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-150 for antimicrobial resistance.
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
Therapix Biosciences Ltd.
For further information: +972-3-616-7055
Media Contact:
Susan Forman
DGI
+1-212-825-3210
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SOURCE Therapix Biosciences Ltd.
Therapix Biosciences and Assuta Medical Center to Initiate Clinical Trial in
Obstructive Sleep Apnea
- Planned Phase IIa Trial Will Expand the Company’s Proprietary Cannabinoid-Based
Technology Pipeline to Potentially Treat Three Therapeutic Areas of High Unmet
Need -
TEL AVIV, Israel, - October 18, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty, clinical-stage pharmaceutical company focusing on the development
of cannabinoid-based treatments, signed an agreement with Assuta Medical Center,
the largest hospital network and private healthcare provider in Israel, to
conduct a Phase IIa, sponsor-initiated trial (the “OSA Trial”) for the treatment
of Obstructive Sleep Apnea (“OSA”) using the Company’s proprietary cannabinoid-based
technology, THX-OSA01.
The OSA trial, titled “Examining the Efficacy of a Therapeutic Combination of
Dronabinol (synthetic ?9-tetrahydracannabinol) and Palmitoylethanolamide for
Obstructive Sleep Apnea,” will be conducted under the leadership of Professor
Yaron Dagan, head of the Sleep Medicine Institute at Assuta, and Principal
Investigator, Dr. Lilach Kemer. Thirty patients with a confirmed OSA diagnosis
will be evaluated for one month with the primary efficacy endpoint evaluating a
significant change in the AHI Index, which assesses the quality of sleep before
and after treatment.
Professor Dagan said, “Breathing sleep disorders affect a substantial and
growing percentage of the adult population. Currently, the standard treatments
for obstructive sleep apnea (OSA) are noninvasive ventilation devices (CPAP) and
oral appliances that are very inconvenient to the patient, thus result in low
compliance. There are currently no approved pharmaceutical approaches. As such,
we are enthusiastic to be working with Therapix in its development of a
potentially transformational therapy in this area of high unmet medical need.”
Dronabinol, one component of THX-OSA01 and an exogenous CB1 and CB2 receptor
agonist, has been shown in a proof-of-concept study by an independent group to
potentially reduce abnormal respiratory events and associated hypoxemia in
patients with OSA. In a study, conducted by researchers from the department of
medicine at the University of Illinois, Chicago, in 17 adults with
moderate-to-severe OSA, dronabinol significantly reduced the apnea-hypopnea
index (“AHI Index”).
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix, said, “We are
excited to collaborate with Professor Dagan, a recognized key opinion leader and
world-renowned expert in sleep medicine. A main point of interest in this trial
will be investigating the power of the ‘entourage effect,’ which we have
previously observed in our proprietary compound in other indications, to enhance
the treatment of OSA. We believe the benefits of this effect, in which the two
cannabinoids, tetrahydracannabinol (THC) and palmitoylethanolamide (PEA) work
synergistically, ensure this trial will expand our knowledge of the utility of
THX-OSA01 as a potential OSA treatment.”
Josh Blacher, Chief Financial Officer of Therapix, said, “In addition to the
potential commercial opportunities we believe may lie ahead of us in our
proprietary treatments for Tourette syndrome and Traumatic Brain Injury, our
exploration of the OSA market is a third indication that may have potential to
be commercialized in the future if our clinical trials are successful.”
According to the American Academy of Sleep Medicine (AASM) and Frost & Sullivan,
a global research and consulting firm, OSA affects 29.4 million American men and
women, which represents 12 percent of the U.S. adult population and the economic
burden of undiagnosed sleep apnea in United States alone is estimated at nearly
$150 billion annually by Frost & Sullivan.
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 two internal drug development programs based on repurposing an FDA approved
synthetic cannabinoid (dronabinol): THX-OCA01 targets the treatment of the
symptoms of Tourette Syndrome; and THX-ULD01 targets the high-value and
under-served market of mild cognitive impairments and Traumatic Brain Injury (TBI).
Please visit our website for more information at www.therapixbio.com.
About THX-OSA01:
THX-OCA01 is a drug candidate for the treatment of the symptoms of obstructive
sleep apnea 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 endocannabinoid 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 Obstructive Sleep Apnea:
According to the Mayo Clinic, obstructive sleep apnea, or OCA, is a potentially
serious sleep disorder. It causes breathing to repeatedly stop and start during
sleep. There are several types of sleep apnea, but the most common is
obstructive sleep apnea. This type of apnea occurs when your throat muscles
intermittently relax and block your airway during sleep. A noticeable sign of
obstructive sleep apnea is snoring. OSA affects 29.4 million American men and
women, which represents 12 percent of the U.S. adult population, according to
The American Academy of Sleep Medicine (AASM) and Frost & Sullivan.
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-OSA01 for the treatment of
Obstructive Sleep Apnea. 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
Therapix Biosciences Ltd.
For further information: +972-3-616-7055
Media Contact:
Susan Forman, DGI
+1-212-825-3210
SOURCE Therapix Biosciences Ltd
___________________________________________
Recent Therapix Biosciences News:
Therapix Signs Formulation Development and Clinical Manufacturing Agreement with
Catalent for THX-TS01
- First Time Tetrahydrocannabinol (THC) and Palmitoylethanolamide (PEA) To Be
Combined in Proprietary Formulation -
TEL AVIV, Israel, - October 6, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty, clinical-stage pharmaceutical company focusing on the development
of cannabinoid-based treatments, today announced it has entered into an
exclusive agreement with Catalent Pharma Solutions, the leading global provider
of advanced delivery technologies and development solutions for drugs, biologics
and consumer health products, for the formulation, development and clinical
manufacturing of THX-TS01, a first-in-class, proprietary investigational drug
candidate for the treatment of the symptoms of Tourette Syndrome.
Pursuant to the agreement, Catalent will develop THX-TS01 in softgel form in
support of Therapix’s clinical development program and in accordance with
current good manufacturing practice (cGMP). The formulation, development,
analytical and cGMP manufacturing activities will be conducted at Catalent’s
primary softgel development and manufacturing facility in St. Petersburg,
Florida.
Ascher Shmulewitz, M.D., Ph.D., Therapix’s Chairman of the Board of Directors,
said, “This is the first time that two cannabinoids, Tetrahydrocannabinol and
Palmitoylethanolamide, which we believe work synergistically, are being combined
in a proprietary single dose that may potentially provide a turnkey solution to
addressing the symptoms of Tourette Syndrome. Our objective in developing
THX-TS01 is to enable the commercialization of a more effective treatment for
the symptoms of this devastating, unmet medical need. We believe that this
agreement may bring us one step closer to this goal.”
Dr. Shmulewitz continued, “This agreement with Catalent—a world-class drug
development, delivery and supply organization—reflects our belief in the promise
of THX-TS01 as we look forward to advanced-stage clinical trials and, if
successful, commercialization. We could not be more pleased with Catalent as our
new development and manufacturing partner.”
“The potential benefits of combining Tetrahydrocannabinol and
Palmitoylethanolamide into a fully-optimized single dose, are manifold,” said
Adi Zuloff-Shani, Ph.D., Therapix’s Chief Technology Officer. “This unique
formulation could offer an enhanced biological effect and extended duration
greater than that presented by administration of each component on its own.”
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 two internal drug development programs based on repurposing an FDA approved
synthetic cannabinoid (dronabinol): THX-TS01 targets the treatment of the
symptoms of Tourette Syndrome; and THX-ULD01 targets the high-value and
under-served market of mild cognitive impairments and Traumatic Brain Injury (TBI).
Please visit our website for more information at www.therapixbio.com.
About Catalent:
Catalent is the leading global provider of advanced delivery technologies and
development solutions for drugs, biologics and consumer health products. With
over 80 years serving the industry, Catalent has proven expertise in bringing
more customer products to market faster, enhancing product performance and
ensuring reliable clinical and commercial product supply. Catalent employs
approximately 10,000 people, including over 1,400 scientists, at more than 30
facilities across five continents, and in fiscal 2017 generated more than $2
billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.
For more information, visit www.catalent.com.
More products. Better treatments. Reliably supplied.™
About THX-TS01
THX-TS01 is a combination drug candidate for the treatment of the symptoms 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 endocannabinoid 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. Such forward-looking
statements used in this press release include, among other things, references to
the clinical and commercial potential of THX-TS01 for the treatment of Tourette
Syndrome. 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
Therapix Biosciences Ltd.
For further information: +972-3-616-7055
Media Contact:
Susan Forman, DGI
+1-212-825-3210
SOURCE Therapix Biosciences Ltd
Therapix’s First-in-Class Therapy Demonstrates Reversal of Age-Related Cognitive
Impairment in Pre-Clinical Study
- THX-ULD01 Being Developed for Treatment of Mild Cognitive Impairment -
- Data to be Presented at IACM Conference on September 29-30 -
TEL AVIV, Israel, - September 27, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
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 2 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, “These
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, these data echo 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
Therapix Biosciences Reports Second Quarter 2017 Financial Results and Provides
Business Update
- Conference Call and Webcast Today at 8:30 a.m. EDT / 5:30 a.m. PDT -
TEL AVIV, Israel, - August 10, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty clinical stage pharmaceutical Company specializing in the
development of cannabinoid-based drugs, today reported financial results for the
three and six months ended June 30, 2017. The Company will host a conference
call and webcast today to discuss the financial results and to provide an update
on current developments with respect to its clinical programs..
Financial Summary – Second Quarter 2017 vs. Second Quarter 2016 (Note: The
functional currency of the Company is New Israeli Shekel; for presentation
purposes, the financial data herein is presented in USD):
• Net loss of $1.9 million, or $0.54 per ADS, for the three months ended June
30, 2017, compared to a net loss of $0.5 million, or $0.61 per ADS, for the
three months ended June 30, 2016. This period's net loss included $0.44 million
of exchange rate differences on balances of cash and cash equivalents, versus
none incurred during the corresponding period in 2016.
• Research and development ("R&D") expenses amounted to approximately $0.46
million for the three months ended June 30, 2017, compared to approximately
$0.23 million for the three months ended June 30, 2016. The increase resulted
primarily from a marked rise in expenses in connection with the clinical trials,
as well as a R&D studies.
• General and administrative expenses amounted to approximately $0.97 million
for the three months ended June 30, 2017, compared to approximately $0.30
million for the three months ended June 30, 2016. The increase resulted
primarily from a rise in investor relations and business development activities.
• Cash totaled $11.8 million as of June 30, 2017, compared to $12.1 million at
March 31, 2017. The increase in cash primarily resulted from additional net
proceeds raised in the Company’s Initial Public Offering through the complete
exercise of the underwriter’s overallotment option, as well as expenses incurred
in our ongoing clinical trials, other R&D expenses, investor relations and
business development activities and operational activities. The Company
currently believes that its cash balance will be sufficient to maintain its
current operations into the third quarter of 2018.
Business update and developments in the Company’s clinical R&D programs:
• In the Company’s ongoing study Phase IIa clinical trial in Tourette’s Syndrome
at Yale University (n=18), 12 patients have been enrolled to date; patient #13
is scheduled to be screened this week. The last patient is currently projected
to be enrolled by the end of September or early October, 2017, which is
consistent with our previously disclosed estimate. To date, ten patients have
completed the entire three-month treatment regimen.
• In the Yale study, patients that have completed the initial 3-month treatment
period have been given the option to extend their treatment for an additional 3
months based on a positive assessment of efficaciousness after the first 3
months. Of the 10 patients that have already completed the initial 3-month
treatment period, 8 patients have opted to extend their treatment.
• Regarding our Phase IIb, placebo-controlled 13-week clinical trial in
Tourette’s Syndrome, previously anticipated to be conducted at the Hannover
Medical School in Germany, we are currently assessing the option to conduct a
study in the United States as well. .We should be able to complete our decision
within a few weeks. This will cause an immaterial delay in initiating the study.
• Concerning our second clinical program for our Ultra-Low-Dose formulation of
THC for the treatment of Mild Cognitive Impairment (“MCI”), the Company has
completed the development of a formulation of sublingual administration of THC
with expected enhanced bioavailability. Within the broader MCI indication, we
are now focusing on the narrower Traumatic Brain Injury (“TBI”) indication, and
are now assessing the optimal regulatory pathway for this program. As a result,
this will likely cause a delay in the initiation of the PK study. Nonetheless,
we currently project this study will be initiated in the fourth quarter of 2017.
The duration of this study is expected to be 1 month. From there, the Company
intends to advance to a proof-of-concept trial. In addition to the sublingual
administration, we are currently working on a nasal delivery formulation.
• In the anticipated proof-of-concept study in MCI, the Company will be
evaluating cognition in TBI patients who are generally symptomatic with
significant cognitive dysfunction. The primary endpoint is expected to measure
the cognitive functions post injury. The Company currently intends to initiate a
similar pre-clinical study in small animals towards the end the third quarter,
2017, or early fourth quarter 2017, which is materially on track with our
earlier disclosed estimate.
Conference Call & Webcast:
Thursday, August 10, 2017, 8:30 am Eastern Time / 5:30 am Pacific Time
Participant Dial-In Numbers:
Toll-Free: +1-877-870-4263
Toll/International: +1-412-317-0790
Webcast: https://www.webcaster4.com/Webcast/Page/1726/22002
Replay, available until Aug 17, 2017
Replay Dial-In Numbers:
Toll-Free: +1-877-344-7529
Toll/International: +1-412-317-0088
Passcode: 10110882
See the full financial tables on Yahoo
Finance at:
https://finance.yahoo.com/quote/TRPX/press-releases?p=TRPX
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
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
search for a U.S. based Chief Executive Officer. 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
For further information: +972-3-616-7055
SOURCE Therapix Biosciences Ltd
Therapix Biosciences Second
Quarter 2017 Conference Call and Webcast Scheduled for Thursday, August 10, 2017
TEL AVIV, Israel, - August 3, 2017 - /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"), a specialty clinical stage
pharmaceutical Company specializing in the development of cannabinoid-based
drugs, announced today that it will host a conference call and webcast on
Thursday, August 10, 2017, to discuss results for the period ended June 30, 2017
and to provide an update on current developments with respect to its clinical
programs:
Conference Call & Webcast:
Thursday, August 10, 2017, 8:30 am Eastern Time / 5:30 am Pacific Time
Participant Dial-In Numbers:
Toll-Free: +1-877-870-4263
Toll/International: +1-412-317-0790
Webcast: https://www.webcaster4.com/Webcast/Page/1726/22002
Replay, available until Aug 17, 2017
Replay Dial-In Numbers:
Toll-Free: +1-877-344-7529
Toll/International: +1-412-317-0088
Passcode: 10110882
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.
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
search for a U.S. based Chief Executive Officer. 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
View original content:http://www.prnewswire.com/news-releases/therapix-biosciences-second-quarter-2017-conference-call-and-webcast-scheduled-for-thursday-august-10-2017-300498696.html
SOURCE Therapix Biosciences Ltd
CURE Pharmaceutical & Therapix Biosciences Signs MOU with Israel’s Assuta
Medical Center to Develop First-in-Class Therapeutic Products in Fields of
Personalized Medicine & Cannabinoids
TEL AVIV, Israel, - July 11, 2017 - /PRNewswire/ -- CURE
Pharmaceutical (OTCQB: CURR), (“CURE”), a leading disruptive drug delivery
technology and pharmaceutical cannabinoid molecule development company and Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty clinical-stage pharmaceutical company dedicated to the development
of cannabinoid-based drugs headquartered in Israel, announced today that they
signed a memorandum of understanding (MOU) to enter into a research
collaboration with Israel’s largest and leading private medical services center,
Assuta Medical Centers, Ltd., (“Assuta”). The Companies will collaborate to
advance, research, develop and commercialize potential therapeutic products in
the fields of personalized medicine and cannabinoids.
“As CURE focuses on targeting unmet needs in traditional pharmaceutical markets
that could be disrupted by cannabinoid-based options, we are continuously
looking to help bring new therapeutic cannabinoid-based products to market and
further efforts toward the creation of personalized medicine,” said Robert
Davidson, CEO of CURE Pharmaceutical. “Our new collaboration with Therapix and
Assuta, two leading companies in Israel, a Country that is at the forefront of
cannabinoid-based research in the world, is the perfect place to start the
development of these products.”
Dr. Ascher Shmulewitz, Chairman of Therapix, added, “CURE is the ideal partner
for us to enter this promising and cutting-edge personalized cannabinoid-based
therapeutics; this deal has all the signs of a fruitful venture.”
As agreed to in the MOU, the Companies intend to formalize the pooling of
professional, scientific, financial resources and expertise, in order to benefit
from each of its respective advantages and capabilities to develop new
therapeutic products in the fields of personalized medicine and cannabinoids.
Specifically, CURE and Therapix will provide support and expertise in the
development of pharmaceutical products, while Assuta will support the early
research and development of potential projects through its research and
facilities.
“Assuta is happy to enter into the MOU with CURE and Therapix, and I am
confident that the parties’ cooperation will be a successful one, with many
other projects to follow,” said Professor Ari Shamiss, CEO of Assuta. “This new
collaboration is yet another step Assuta is taking in the innovation world, and
one of many steps to be taken by Assuta in the field of biopharma.”
###
About CURE Pharmaceutical
Headquartered in Oxnard, California, CURE Pharmaceutical (OTC:CURE) is a fully
integrated specialty pharmaceutical/bioscience company that leverages disruptive
proprietary drug delivery technologies for a broad range of molecules serving
the biopharmaceutical, veterinarian, medical foods and pharmaceutical cannabis
markets. CURE develops its patented and proprietary delivery system (CureFilm™),
the most advanced oral thin film on the market today, from its industry leading
full service cGMP manufacturing facility. The Company’s mission is to deliver
proven drugs in a fast and efficient manner and to improve quality of life.
For more information about CURE Pharmaceutical, please visit its website at
www.curepharmaceutical.com.
About Therapix Biosciences Ltd.
Therapix Biosciences Ltd. (Nasdaq:TRPX) is a specialty clinical-stage
pharmaceutical company focused on developing technologies and therapeutics based
on cannabinoid pharmaceuticals. The Company’s clinical pipeline assets follow a
de-risked 505(b)(2) regulatory pathway benefitting from Therapix’s unique
proprietary formulations based on repurposing an FDA approved synthetic
cannabinoid (dronabinol). Therapix’s lead compound, THX-TS01, is currently in
Phase 2 clinical trials for Tourette’s Syndrome and the Company intends to
initiate a Phase 1 clinical study of THX-ULD01 for the treatment of Mild
Cognitive Impairment, for which no FDA-approved therapies currently exist.
Please visit our website for more information at www.therapixbio.com.
About Assuta Medical Centers
Assuta Medical Centers (https://www.assuta.co.il/en/) is the largest private
hospital network in Israel operating 8 hospitals and medical centers from north
to south. Owned by Maccabi Healthcare, the second largest HMO in Israel, Assuta
accounts for about 15% of the surgeries in Israel and takes care of the health
of more than 1 million patients yearly. Assuta holds JCI quality accreditation
with excellence and its service standards are ranked as top tier by the ministry
of health.
Forward-looking statements
This press release contains forward-looking statements, which are subject to
risks and uncertainties. All statements, other than statements of fact,
including those statements with respect to the Company's business development,
are forward-looking statements. Forward-looking statements speak only as of the
date made and are not guarantees of future performance. We undertake no
obligation to publicly update or revise any forward-looking statements.
Public Relations Contact
Andrew Hard
Chief Executive Officer
CMW Media
andrew.hard@cmwmedia.com
P. +1888 829-0070
www.cmwmedia.com
Investor Relations Contact
Shiwei Yin, Grayling
Shiwei.Yin@grayling.com
P. +1646 284-9474
Lucia Domville, Grayling
lucia.domville@grayling.com
P. +1646 284-9416
SOURCE Therapix Biosciences Ltd
Therapix Biosciences to Ring the
Nasdaq Stock Market Opening Bell
TEL AVIV, Israel, /PRNewswire/ -- Therapix Biosciences Ltd.
(NASDAQ: TRPX) ("Therapix"),
a specialty clinical-stage pharmaceutical company specializing in the
development of cannabinoid-based drugs, today announced that the Company will
ring The Nasdaq Stock Market Opening Bell in New York, NY on Wednesday, June 28,
2017 in honor of its initial public offering (IPO) of American Depository Shares
(ADSs) listed on the Nasdaq Capital Market in March 2017.
Dr. Elran Haber, Ph.D., Chief Executive Officer of Therapix, stated, "We're
proud to celebrate the successful uplisting to the Nasdaq Capital Market as
Therapix builds recognition in the U.S. markets to grow exposure to a broader
and more diverse
investor audience. As we ring the opening bell, I would also like to take this
moment to acknowledge and thank the employees, investors and partners who have
supported Therapix in our journey thus far. With Therapix running two U.S.
clinical studies in 2017 and data on one of them to be released this year,
today's celebration comes at a landmark point in our timeline."
A live webcast of The Nasdaq Stock Market Opening Bell ceremony will be
available at https://livestream.com/nasdaq/live and also on the Investor
Relations portion of Therapix's website at www.therapixbio.com.
Therapix began trading on the Nasdaq Capital Market on March 22, 2017, under the
symbol "TRPX".
About Therapix Biosciences
Therapix Biosciences Ltd. (Nasdaq: TRPX) is a specialty clinical-stage
pharmaceutical company focused on developing technologies and therapeutics based
on cannabinoid pharmaceuticals. The Company's clinical pipeline assets follow a
de-risked 505(b)(2) regulatory pathway benefitting from Therapix's unique
proprietary formulations based on repurposing an FDA approved synthetic
cannabinoid (dronabinol). Therapix's lead compound, THX-TS01, is currently in
Phase 2 clinical trials for Tourette's Syndrome and the Company intends to
initiate a Phase 1 clinical study of THX-ULD01 for the treatment of Mild
Cognitive Impairment, for which no FDA-approved therapies currently exist.
Please visit our website for more information at www.therapixbio.com.
Contacts
Josh Blacher
Chief Financial Officer
josh@therapixbio.com
Tirth Patel (investors)
Edison Group
tpatel@edisongroup.com
SOURCE Therapix Biosciences Ltd
Therapix Biosciences and the
Hannover Medical School Enter into an Investigator-initiated Clinical Trial
Agreement to Assess the Effect of TXH-TS01 in Patients with Tourette Syndrome
TEL AVIV, Israel, /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
SOURCE Therapix Biosciences Ltd
-------------------------------------------------------------------
About Therapix Biosciences Ltd:
Therapix Biosciences:
Specialty pharmaceutical company developing unique cannabinoid technologies in
treatment of central nervous system disorders
About Therapix Biosciences — Company Overview
Therapix Biosciences Ltd. (NASDAQ: TRPX) is an emerging specialty pharmaceutical
company developing unique cannabinoid technologies in treatment of central
nervous system (CNS) disorders.
Therapix is engaged in two drug development programs based on repurposing an
FDA, approved synthetic cannabinoid (dronabinol):
THX-TS01: for the treatment of symptoms related to Tourette Syndrome (TS), and
THX-ULD01: targeted to the high value and under-served market of mild cognitive
impairment (MCI)
Therapix has filed for Orphan Drug Designation for its THX-TS01 program
formulation, which provides for a seven-year exclusive marketing period in the
United States. Therapix also intends to pursue Orphan Drug Designation in
Europe.
In a letter dated September 29, 2016, the FDA informed us that our request
cannot be granted at this time, and is being held in abeyance until and subject
to us providing the FDA additional information pertaining to the overall
prevalence of TS in both children and adults, and further clinical data to
support our scientific rationale for our request for orphan drug designation
within 12 months. We intend to respond within the 12 month period, or during any
extension thereof
For its near-term THX-TS01 development program and the longer term THK-ULD01
program targeted to MCI, Therapix is pursuing a 505 (b)(2) regulatory strategy
for FDA approval.
Therapix is also developing unique cannabinoid delivery technologies to improve
drug administration, including nasal and sublingual delivery methods for THC,
with formulations designed to increase efficacy compared with standard oral
administration.
Approvals for indications such as TS and MCI may lead to applications in several
additional therapeutic indications, including pain, cancer, anti-inflammatory,
dermatology, and psychiatric disorders.
Repurposing Approved Cannabinoids for New Indications:
Using FDA approved compound: Dronabinol (biosynthetic THC)
Effective as stand-alone or in combination
Significant benefits of cannabis shown in multiple indications: CNS, pain,
cancer, anti-inflammatory, dermatology, psychiatric disorders
TWO CLINICAL PROGRAMS TO TREAT UNDERSERVED CENTRAL NERVOUS SYSTEM DISORDERS
THX-TS01: for the treatment of symptoms related to Tourette Syndrome (TS).
Several studies show the beneficial effects of THC in treatment of TS patients.
The THX-TS01 program takes a unique approach to cannabinoid formulation using
the “Entourage Effect.” THX-TS01 is a combination drug based on dronabinol, an
FDA approved synthetic analog of THC, and PEA, PEA is naturally occurring in
various food sources such as egg yolk, soybeans and milk. In parts of Europe,
PEA derived products (e.g., Normast® and Pelvilen®) have been marketed as a food
for special medical purposes. In April 2015, Health Canada added PEA to its list
of Natural Health Products, a class of health products which includes vitamins,
mineral supplements, herbal preparations, traditional and homeopathic medicines,
probiotics and enzymes.
Therapix is seeking orphan drug designation to treat TS.
In a letter dated September 29, 2016, the FDA informed us that our request
cannot be granted at this time, and is being held in abeyance until and subject
to us providing the FDA additional information pertaining to the overall
prevalence of TS in both children and adults, and further clinical data to
support our scientific rationale for our request for orphan drug designation
within 12 months. We intend to respond within the 12 month period, or during any
extension thereof.
THX-ULD01: targeted to the high value and under-served market of mild cognitive
impairment (MCI), using a unique and proprietary drug development platform: The
“Ultra Low-Dose.”
Pipeline
Both programs use a 505 (b)(2) regulatory strategy based on prior FDA approval
of dronabinol. The 505 (b)(2) strategy entails a relatively low
scientific-technological risk compared with development of new chemical
entities, combined with relatively low development costs and fast time to
market.
Therapix is developing unique nasal and sub-lingual delivery and formulations to
optimize efficacy of active cannabinoid compounds. Nasal and sub-lingual
administration of THC has been shown to be superior to oral administration.
Approvals for indications such as TS and MCI may lead to applications in several
additional therapeutic indications, including pain, cancer, anti-inflammatory,
dermatology, and psychiatric disorders.
THX-TS01: THC and PEA Formulation for the Treatment of Tourette Syndrome
Tourette Syndrome (TS) is a neuropsychiatric disorder with increased prevalence
among children. According to the 2011–2012 National Survey on Children’s Health,
one out of every 360 children in the US have been diagnosed with TS, and about
35,000 children have moderate or severe TS. Symptoms are physical and vocal tics
that can be disabling and associated with hyperactivity, anger control problems,
sleep disorders, and obsessive compulsive behavior. Current pharmacological
treatments have very limited efficacy and are almost always accompanied by
severe side effects. Medications used to treat TS, such as antipsychotic drugs,
Alpha Adrenergic Agonists used for hypertension and migraine headaches, and
anticonvulsant drugs, often have black box warnings for serious hazards.
UNIQUE APPROACH
Several studies show the beneficial effects of THC in treatment of TS patients.
The THX-TS01 program takes a unique approach to cannabinoid formulation using
the “Entourage Effect,” in which Endocannabinoid system constituents work
synergistically together. The Entourage technology is licensed by Therapix.
The Therapix THX-TS01 compound is a combination drug based on:
Dronabinol (synthetic THC), the psychoactive molecule in the cannabis plant.
Cannabinoids such as synthetic THC are used in treating a wide range of medical
conditions, such as pain reduction, anti-inflammation, and reduction or
prevention of nausea. They are used by cancer patients undergoing chemotherapy
and for mental health conditions such as anxiety and posttraumatic stress
disorder.
PEA is naturally occurring in various food sources such as egg yolk, soybeans
and milk. In parts of Europe, PEA derived products (e.g., Normast® and Pelvilen®)
have been marketed as a food for special medical purposes. In April 2015, Health
Canada added PEA to its list of Natural Health Products, a class of health
products which includes vitamins, mineral supplements, herbal preparations,
traditional and homeopathic medicines, probiotics and enzymes.
“ENTOURAGE EFFECT”
The “Entourage Effect” was first described by Professor Raphael Mechoulam in
1998. Professor Mechoulam, a world renowned expert on pharmaceutical
cannabinoids and member of the Therapix Medical Advisory Board. Based on
Therapix
research
and preclinical studies, dronabinol and PEA have been shown to work better
together than use of THC or PEA alone. PEA is in the endocannabioid family and
is believed to be a pain reliever and anti-inflammatory agent. Combining PEA
with dronabinol may stimulate cannabinoid receptors, inhibit metabolic
degradation, and thus increase uptake of THC. The overall benefits of the PEA
combination are considered to be an increase in efficiency of oral
administration, enabling a decrease in dosage and lowering of side effects and
adverse events.
Therapix is seeking orphan drug designation for its compound.
THX-ULD01: Ultra-Low Dose THC to Improve Cognitive Abilities
Therapix is developing THX-ULD01, a new, ultra-low dose formulation of
dronabinol, combined with sublingual and nasal delivery methods, to provide a
treatment for Mild Cognitive Impairment (MCI). MCI is a pre-Alzheimer’s
condition associated with problems with memory, language, thinking and judgement.
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 no FDA approved
treatment for MCI.
Therapix has compelling preclinical animal data demonstrating that ultra-low
dose dronabinol improves cognitive abilities. Recent studies have found that an
ultra-low dose of THC protects the brain from long-term cognitive impairment
which may be caused by lack of oxygen supply, seizures or use of drugs. Studies
also suggest that ultra-low doses of THC cause animals to improve performance in
behavioral tests that measure learning and memory.
Therapix plans to initiate a prospective, open label, randomized Phase IIa
clinical trial to evaluate the safety, tolerability and efficacy of THX-ULD01 in
treating patients with cognitive impairment. The primary efficacy endpoint of
this trial will be change from baseline to end of 6-weeks in the Computerized
Neurocognitive Battery, or CNB. CNB measures the performance, accuracy and speed
of specific neurobehavioral domains using previously validated tests. Secondary
efficacy end points will demonstrate safety and tolerability of THX-ULD01 and
evaluate the benefit of THX-ULD01 on patient mood, anxiety and overall quality
of life using the Hamilton scale.
Therapix is building a specialty pharmaceutical company focused on significantly
enhancing FDA-approved dronabinol for the treatment of Tourette Syndrome and
Mild Cognitive Impairment.
DR. ELRAN HABER
Chief Executive Officer
Dr. Haber has served as Therapix’s Chief Executive Officer since November 2015.
Previously, Dr. Haber had served as the company’s Vice President of Business
Strategy and Innovation, beginning in March of 2014. Dr. Haber spent more than
10 years as Chairman and board member of several privately held, and publicly
traded, companies including Issta Lines Ltd. (TASE: “ISTA”) from 2007 to 2012,
American Express Global Business Travel — Israel (Histour-Eltive Ltd.) from 2010
to 2012, and has been a member of various board committees. Dr. Haber has served
in senior executive roles in various life science companies and a private
investment firm. Dr. Haber holds a Ph.D. in Pharmaceutical Science and an M.B.A.
in Finance & Financial Engineering, both from The Hebrew University of
Jerusalem, Israel.
JOSH BLACHER
Chief Financial Officer
Mr. Blacher joined Therapix in 2017 bringing with him more than nine years of
experience in biotech-related financial management, including as a CFO of a
NASDAQ-traded company, business development, investing and operations, as well
as 14 years in capital markets. Prior to joining Therapix, Mr. Blacher was the
CFO for Galmed Pharmaceuticals, and earlier served as Director of Business
Development at Teva Innovative Ventures, Teva Pharmaceuticals’ early- and
mid-stage investment and in-licensing arm. In that capacity, Mr. Blacher helped
build and manage Teva’s portfolio of approximately 20 equity investments in
biotech entities, spanning a wide range of development stage companies from
pre-clinical through Phase III projects, and various therapeutic areas. Mr.
Blacher also held positions in portfolio management at Deutsche Asset Management
and equity research at Morgan Stanley, as well as in mergers & acquisitions at
Lehman Brothers. Mr. Blacher holds an MBA in Finance from Columbia Business
School.
DR. ADI ZULOFF-SHANI
Chief Technology Officer
Dr. Adi Zuloff-Shani has served as Chief Technologies Officer at Therapix since
February 2016, bringing with her more than 15 years of experience as an R&D
executive. From 2012 until 2016, Dr. Zuloff–Shani served as a Vice President of
Development at Macrocure Ltd. (NASDAQ: “MCUR”) where, aside from leading all
research and development activities, she interacted, and was involved, with the
activities of all departments including clinical, operations, quality assurance,
quality control, finance, and regulatory affairs. Prior to that, Dr.
Zuloff-Shani spent eight years as the Senior Scientist in the Research &
Development Unit of Magen David Adom’s National Blood Services. Dr. Zuloff-Shani
holds a Ph.D. in human biology and immunology from Bar-Ilan University, Israel.
DORON BEN AMI
Chief Strategy Officer
Mr. Doron Ben Ami has been Therapix’s Chief Strategy Officer since December
2015. A seasoned executive with more than 20 years of management experience, he
has held various leadership roles in the multinational pharmaceutical industry.
Mr. Ben Ami previously held a range of executive positions including Associate
Vice President for the Eastern European and Israel region at Merck (from 2010 to
2015), Managing Director of the Merck subsidiary in Israel (from 2008 to 2010),
and General Manager of Lundbeck Israel (from 2002 to 2008). Since 2015, Mr. Ben
Ami has served as a Senior Consultant at The Harel Group Inc., a U.S. based
business development advisory firm that connects innovative pharmaceutical
companies with strategic partners. Mr. Ben Ami holds a Master of Health Systems
Administration degree (M.H.A.) from Tel Aviv University, Israel.
.SOURCE: http://therapixbio.com/
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Therapix Biosciences Ltd coverage by
the company. FNMG HOLDS NO SHARES OF Therapix Biosciences Ltd
This release contains "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E the Securities
Exchange Act of 1934, as amended and such forward-looking statements are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. "Forward-looking statements" describe future expectations,
plans, results, or strategies and are generally preceded by words such as "may",
"future", "plan" or "planned", "will" or "should", "expected," "anticipates",
"draft", "eventually" or "projected". You are cautioned that such statements are
subject to a multitude of risks and uncertainties that could cause future
circumstances, events, or results to differ materially from those projected in
the forward-looking statements, including the risks that actual results may
differ materially from those projected in the forward-looking statements as a
result of various factors, and other risks identified in a company's annual
report on Form 10-K or 10-KSB and other filings made by such company with the
Securities and Exchange Commission. You should consider these factors in
evaluating the forward-looking statements included herein, and not place undue
reliance on such statements. The forward-looking statements in this release are
made as of the date hereof and FNMG undertakes no obligation to update such
statements.
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