July 8, 2014
TORONTO, CANADA - Cynapsus Therapeutics Inc. (CTH:
TSX-V) (CYNAF: OTCQX) today announced that it has been awarded a
new grant of US$500,000 from The Michael J. Fox Foundation for
Parkinson's Research (MJFF) to support clinical studies to develop
APL-130277, a sublingual thin film strip reformulation of
apomorphine. This second MJFF grant will be used to fund the
Company's CTH-105 clinical study.
APL-130277 is an easy-to-administer, fast-acting
and proprietary reformulation of apomorphine for sublingual
delivery. Injectable apomorphine is the only approved drug in the
United States, Europe, Japan and other countries for the acute
rescue of "off" motor symptoms of Parkinson's disease. The
APL-130277 thin film strip system technology is specifically
designed to provide enhanced convenience and eliminate buccal
mucosal irritation, among other attributes.
CTH-105 is a pilot study in patients with
Parkinson's disease who are naïve to the use of apomorphine and who
experience at least one daily "off" episode with a total duration
of "off" in any 24-hour period of at least 2 hours. This study is
planned to examine the effect of APL-130277 on relieving "off"
episodes over a single day with a dose-titration used to determine
dose strengths necessary for future clinical development. This
study and future trials of APL-130277 will be listed on Fox Trial
Finder, an online tool from MJFF matching interested research
volunteers with recruiting clinical studies.
"The options for patients living with "off"
episodes are limited and unfavorable," says Maurizio Facheris, MD,
MSc, Associate Director of Research Programs at MJFF. "Initial
results of Cynapsus' novel formulation (APL-130277) show this
therapy may offer not only a more palatable solution for motor
fluctuations, but also a longer window of efficacy, thereby
postponing dopamine replacement dosing and lessening associated
side effects."
"This second grant from The Michael J. Fox
Foundation is very important to Cynapsus, as it solidifies the
partnership we have forged with the Foundation to focus on
improving the daily lives of Parkinson's patients," said Mr.
Anthony Giovinazzo, President and Chief Executive Officer of
Cynapsus. "The CTH-105 clinical trial is our first in
Parkinson's patient study of APL-130277 and will assist us with
dosing information required for the CTH-300a registration study,
which is expected to begin in Q4 2014."
Dr. Albert Agro, the Principal Investigator for
the study and the Chief Medical Officer of Cynapsus added: "The
continued support of The Michael J. Fox Foundation validates our
clinical approach and justifies the need for an improved
formulation of apomorphine in the form of APL-130277. With the help
of the MJFF, we are excited about moving APL-130277 in to patients
this summer in the CTH-105 Phase 2 study."
The MJFF previously awarded Cynapsus an initial
grant of USD$947,925 to complete a comparative study of APL-130277
(i.e. CTH-103) versus subcutaneous injection. The results of
the CTH-103 study were announced on January 13, 2014.
Support for Future
Parkinson's Research
Parkinson's disease is a chronic, degenerative
neurological disorder that results from the loss of
dopamine-producing nerve cells in the brain. Current treatments for
Parkinson's disease are able to reduce the symptoms of the disease
but are not able to treat the underlying neurodegenerative
processes. It is estimated that over one million people in the
United States and 4 to 6 million people globally are living with
Parkinson's disease. According to the U.S. National Institute of
Neurodegenerative Disease and Stroke, the average age of onset is
60, though some people are diagnosed at age 40 or younger.
As part of the MJFF grant agreement, Cynapsus has
made a commitment to support further Parkinson's research by making
up to $1 million in contributions to MJFF based on future potential
sales of APL-130277.
About
Apomorphine
Apomorphine, a potent dopamine agonist, is the
only drug approved specifically for the treatment of acute motor
fluctuations/hypomobility (freezing or "off" episodes) in patients
with advanced Parkinson's disease. Presently, apomorphine is
administered by intermittent subcutaneous injection usually via a
pre-filled injection pen, or, in some cases outside the United
States, by continuous infusion pump. Drawbacks associated with
subcutaneous injection therapy for patients and caregivers include
aversion to needles, the need for multiple injections, which can be
painful and are often associated with irritation and inflammation
at the injection site, and the requirement for a degree of manual
dexterity that some Parkinson's patients find difficult.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company
developing a convenient and easy to use sublingual (oral) thin film
strip for the acute rescue of "off" motor symptoms of Parkinson's
disease. Cynapsus' drug candidate, APL-130277, is an
easy-to-administer, fast-acting reformulation of apomorphine, which
is the only approved drug (in the United States, Europe, Japan and
other countries) to rescue patients from "off" episodes. Cynapsus
is focused on maximizing the value of APL-130277 by completing
pivotal studies in advance of a New Drug Application ("NDA")
expected to be submitted in 2016.
Over one million people in the U.S. and an
estimated 4 to 6 million people globally suffer from Parkinson's
disease. Parkinson's disease is a chronic and progressive
neurodegenerative disease that impacts motor activity, and its
prevalence is increasing with the aging of the population. Based on
a recent study and the results of the Corporation's Global 500
Neurologists Survey, it is estimated that between 25 percent and 50
percent of Parkinson's patients experience "off" episodes in which
they have impaired movement or speaking capabilities. Current
medications only control the disease's symptoms, and most drugs
become less effective over time as the disease progresses.
More information about Cynapsus (TSX-V: CTH)
(OTCQX: CYNAF) is available at www.cynapsus.ca and at the System
for Electronic Document Analysis and Retrieval (SEDAR) at
www.sedar.com.
Contact
Information
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
ajg@cynapsus.ca
Albert Agro
Chief Medical Officer
(416) 703-2449 x252
aagro@cynapsus.ca
Forward Looking
Statements
This announcement contains "forward-looking
statements" within the meaning of applicable securities laws.
Generally, these forward-looking statements can be identified by
the use of forward-looking terminology such as "plans", "expects"
or "does not expect", "is expected", "budget", "scheduled",
"estimates", "forecasts", "intends", "anticipates" or "does not
anticipate", or "believes" or variations of such words and phrases
or state that certain actions, events or results "may", "could",
"would", "might" or "will be taken", "occur" or "be achieved".
Forward-looking statements are subject to known and unknown risks,
uncertainties and other factors that may cause the actual results,
level of activity, performance or achievements of Cynapsus to be
materially different from those expressed or implied by such
forward-looking statements, including but not limited to those
risks and uncertainties relating to Cynapsus' business disclosed
under the heading "Risk Factors" in its March 26, 2014, Annual
Information Form and its other filings with the various Canadian
securities regulators which are available online at www.sedar.com.
Although Cynapsus has attempted to identify important factors that
could cause actual results to differ materially from those
contained in forward-looking statements, there may be other factors
that cause results not to be as anticipated, estimated or intended.
There can be no assurance that such statements will prove to be
accurate, as actual results and future events could differ
materially from those anticipated in such statements. Accordingly,
readers should not place undue reliance on forward-looking
statements. Cynapsus does not undertake to update any
forward-looking statements, except in accordance with applicable
securities laws.
Neither the TSX Venture Exchange nor the OTCQX
International has approved or disapproved the contents of this
press release.
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Cynapsus Therapeutics Inc. via Globenewswire
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