Cynapsus Therapeutics Inc : Cynapsus Therapeutics Commences Phase 2 Clinical Trials in the United States
17 Julio 2014 - 3:15PM
July 17
2014
TORONTO, CANADA - Cynapsus Therapeutics Inc. (CTH:
TSX-V) (CYNAF: OTCQX), a specialty pharmaceutical company focused
on Parkinson's disease, today announced that following
communication from the United States Food and Drug Administration
("the FDA") on July 16, 2014, Phase 2 clinical studies for
APL-130277 will commence immediately. Specifically, clinical study
CTH-105 will be initiated per the proposal submitted to the FDA
under the Company's Investigational New Drug (IND)
application. 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 experienced with Parkinson's
disease.
CTH-105 is a Phase 2 clinical study of
APL-130277. APL-130277 will be studied in 16 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. The first
patients are expected to enter the screening phase before the
end of July. This open-label study will examine the effect of
APL-130277 on relieving "off" episodes over a single day, with
dose-titration used to determine dose strengths necessary for
future clinical development. In particular, the dose strength
information is necessary in order to conduct the larger CTH-300a
efficacy study in apomorphine naïve patients, which is expected to
commence in Q4 2014.
CTH-300a is a double-blind, placebo-controlled,
parallel-design study with Parkinson's patients who have at least
one "off" episode every 24 hours, with total "off" time of at least
2 hours. The primary end point will be the change in the UPDRS III
score.
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.
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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