Cynapsus Announces No Buccal Mucosal Irritation in FDA Registration Study of APL-130277 for Parkinson's Disease
May 14 2014 - 5:00AM
Marketwired Canada
Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF), 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 VENTURE:CTH)(OTCQX:CYNAF) is available at
www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval
(SEDAR) at www.sedar.com.
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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
ajg@cynapsus.ca
Cynapsus Therapeutics
Andrew Williams
COO & CFO
(416) 703-2449 x253
awilliams@cynapsus.ca
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