Cynapsus Therapeutics Commences Phase 2 Clinical Trials in the United States
2014年7月18日 - 5:15AM
Marketwired Canada
Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF), 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 naive 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 naive
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 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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