Cynapsus Therapeutics Announces Data Presentations at the American Academy of Neurology Annual Meeting
(Thomson Reuters ONE) -
-- Poster presentations include clinical data on efficacy, safety and disease
severity --
TORONTO, April 15, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc.
(NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system ("CNS")
pharmaceutical company developing and preparing to commercialize a fast-acting,
easy-to-use, sublingual thin film for the on-demand management of debilitating
OFF episodes associated with Parkinson's disease ("PD"), today announced that
three clinical posters will be presented on Sunday, April 17, 2016 at the 68th
American Academy of Neurology (AAN) Annual Meeting, in Vancouver, British
Columbia, Canada.
The first of three presentations highlights efficacy data from Cynapsus' CTH-
105 Phase 2 trial utilizing a sublingual thin film of apomorphine, APL-130277,
to treat OFF episodes in adult patients with PD. Results demonstrated patients'
mean time to full ON of 24 minutes and mean duration of ON of 50 minutes. In
addition, there was a statistically significant and clinically meaningful
improvement in motor function at all time-points as measured by Movement
Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III).
The second poster presentation discusses safety data from the same trial. The
safety conclusions of this study indicated that APL-130277 was generally well-
tolerated. Most adverse events ("AE"s) were mild to moderate in severity, there
were no discontinuations due to an AE, and there was no apparent dose-response
relationship with AEs observed. The third poster looks at the effects of
sublingual apomorphine by disease severity on the acute management of OFF
episodes in PD. Results from this study showed that APL-130277 rapidly converts
PD patients of various disease severity from OFF to the full ON state. The
posters will be accessible from Cynapsus' corporate website at www.cynapsus.ca.
"The clinical data for APL-130277 in treating OFF episodes in Parkinson's
disease continue to be encouraging. The efficacy and safety data across a range
of patients provide important insights on how our product candidate could be
used to improve patient care," said Albert Agro, Ph.D., Cynapsus' chief medical
officer. "Solid results from our Phase 2 study provide us confidence and
optimism as we look forward to reporting clinical data from our Pivotal Phase 3
efficacy trial over the next several months. We anticipate that these data will
be used to file our new drug application ("NDA") near the end of 2016 or in
early 2017."
The following data will be presented Sunday, April 17, 2016 at AAN from
4:00-5:30 p.m. PDT.
Poster Presentations
1. Safety of Sublingual Apomorphine (APL-130277) for the Treatment of OFF
Episodes in Patients with Parkinson's Disease (Poster #337)
Presenter: Stuart Isaacson, M.D., Parkinson's and Movement Disorders
Specialist, Boca Raton Regional Hospital, Director, Clinical Research
Center, Parkinson's Disease and Movement Disorders Center, Boca Raton,
Florida
2. The Effects of Sublingual Apomorphine (APL-130277) by Disease Severity on
the Acute Management of OFF Episodes in Parkinson's Disease (Poster #336)
Presenter: Holly Shill, M.D., Neurologist, St. Joseph's Hospital and Medical
Center, Phoenix, Arizona, Director, Muhammad Ali Parkinson Center at Barrow
Neurological Institute, Phoenix
3. Efficacy of Sublingual Apomorphine (APL-130277) for the Treatment of OFF
Episodes in Patients with Parkinson's Disease (Poster #335)
Presenter: Robert Hauser, M.D., M.B.A., Professor, Director College of
Medicine - Neurology, Director, Parkinson's Disease and Movement Disorders
Center, University of Southern Florida, Tampa, Florida
About Cynapsus
Cynapsus is a specialty central nervous system pharmaceutical company developing
and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film
for the on-demand management of debilitating OFF episodes associated with PD.
The Company has successfully completed a Phase 2 clinical trial for its product
candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or
apomorphine. Apomorphine is the only molecule approved for acute, intermittent
treatment of OFF episodes for advanced PD patients, but is currently only
approved as a subcutaneous injection in the United States. APL-130277 is a
"turning ON" medication designed to rapidly, safely and reliably convert a PD
patient from the OFF to the ON state while avoiding many of the issues
associated with subcutaneous delivery of apomorphine. It is designed to convert
all types of OFF episodes, including morning OFF episodes, often considered the
most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for
APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in
the United States, and the Company intends to submit an NDA near the end of
2016 or in early 2017. For additional company information, please visit our
website www.cynapsus.ca. For more information about the Phase 3 studies,
including enrollment criteria, please visit the website found here
http://cth300and301trials.cynapsus.ca/
Forward-Looking Statements
This announcement contains "forward-looking statements" within the meaning of
applicable securities laws, including, without limitation, the Company's
expectation for filing an NDA near the end of 2016 or in early 2017; and
expectations regarding the Company's clinical and regulatory activities,
including without limitation, the anticipated timing and completion of clinical
studies. These forward-looking statements include information about possible or
assumed future results of the Company's business, financial condition, results
of operations, liquidity, plans and objectives. In some cases, you can identify
forward-looking statements by terminology such as "believe," "may," "estimate,"
"continue," "anticipate," "intend," "should," "plan," "expect," "predict,"
"potential," or the negative of these terms or other similar expressions. These
forward-looking statements are based on the Company's current expectations and
beliefs and inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ from those anticipated in such
forward-looking statements as a result of risks and uncertainties, and include,
but are not limited to, those factors identified under the caption "Risk
Factors" in the Company's Form 10-K filed with the United States Securities and
Exchange Commission (the "SEC") on March 9, 2016, as amended by Amendment No. 1
to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and
reports in the United States with the SEC available on the SEC's web site
at www.sec.gov, and in Canada with the various Canadian securities regulators,
which are available online at www.sedar.com. Furthermore, unless otherwise
stated, the forward-looking statements contained in this press release are made
as of the date of this press release, and the Company has no intention and
undertakes no obligation to update or revise any forward-looking statements,
whether as a result of new information, future events, changes or otherwise,
except as required by law.
Neither the NASDAQ nor the TSX has approved or disapproved of the contents of
this press release.
Contact Information
Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2499 x246
kgalfetti(at)cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman(at)russopartnersllc.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cynapsus Therapeutics Inc. via GlobeNewswire
[HUG#2003862]
Unternehmensinformation / Kurzprofil:
Datum: 15.04.2016 - 12:00 Uhr
Sprache: Deutsch
News-ID 464328
Anzahl Zeichen: 8968
contact information:
Town:
Toronto, Ontario
Kategorie:
Business News
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