TORONTO, CANADA - Cynapsus Therapeutics Inc. (CTH:
TSX-V) (CYNAF: OTCQX), a specialty pharmaceutical company, today
announced no irritation was observed when testing the APL-130277
sublingual apomorphine formulation in a buccal mucosal irritation
model in hamsters, either macroscopically (clinician observation of
oral cavity) or microscopically. The study was conducted in
compliance with the Good Laboratory Practice for Nonclinical
Laboratory Studies of the United States Food and Drug
Administration ("FDA"), 21 CFR Part 58, and OECD Principles of Good
Laboratory Practice (OECD, 1998).
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.
Mr. Anthony Giovinazzo, President and CEO of
Cynapsus commented: "The data, coupled with our clinical results to
date, continues to validate the design of our thin-film strip
technology. Since we started the development of APL-130277, we
have been aware of the possibility of buccal mucosa irritation with
extended use, so we determined it was prudent to complete this
irritation study sooner rather than later. This study is also
a required registration study by the FDA. We are encouraged
with the results, and look forward to demonstrating similar results
in upcoming human clinical trials planned over the next 24 months.
This study provides evidence that APL-130277 may provide
therapeutic levels of apomorphine dosing with low or no irritation
when used by Parkinson's patients multiple times per day on a daily
basis."
The APL-130277 strips have also been administered
in approximately 100 healthy human volunteers in single dose
studies, with no evidence of irritation.
About The
Buccal Mucosal Irritation Model
In the study, three times each day for 28
consecutive days, an equal number of placebo and apomorphine
containing thin strips were placed in the cheek of the
animals. The dose used in the study was significantly higher,
on a relative weight adjusted basis, than what would normally be
given to patients. Care was taken to apply the thin strips to the
same region of each cheek pouch for every dose application.
There was no external evidence of irritation based
on clinical evaluations of the cheek pouches during the study and
at the end of the 28 days of dosing.
In microscopic analysis there was no observed
evidence of irritation or inflammation.
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 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
Andrew Williams
COO & CFO
(416) 703-2449 x253
awilliams@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.
--30--
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
HUG#1785218
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