TORONTO,
Sept. 2, 2015 (GLOBE NEWSWIRE) --
Cynapsus Therapeutics Inc. (NASDAQ:CYNA)
(TSX:CTH) (the "Company") today announced enrollment of the first
patient in the CTH-301 clinical trial, a pivotal Phase 3 study to examine the
safety and tolerability of APL-130277 for the acute treatment of OFF episodes
in patients with Parkinson's disease (PD). CTH-300, a pivotal Phase 3 efficacy
study, is also ongoing with data expected from both trials in 2016.
Dr. Albert Agro, Chief Medical Officer of Cynapsus, stated,
"Enrolling the first patient in the CTH-301 safety study is a significant
milestone for Cynapsus. The design and endpoints for this study were based on
an End-of-Phase 2 meeting with the FDA earlier this year. The CTH-301 study,
together with the CTH-300 efficacy study, will form the basis for our expected
NDA submission near the end of 2016. We believe that apomorphine, the only
approved drug to rapidly treat OFF episodes, combined with our sublingual film
delivery technology, could provide many patients with a rapid, reliable means
of turning ON from the OFF state."
The CTH-301 trial is a 6-month, open-label, single arm safety
study in PD patients who have at least one OFF episode every 24 hours, with
total OFF time of at least two hours per day. The primary endpoint for the
study is the safety and tolerability of APL-130277 in patients with
PD. The secondary endpoints examine efficacy variables including the
change in the MDS-UPDRS Part III scores over the 6-months of treatment. Sites
will recruit patients over several months, with each patient being evaluated
for six months. An estimated 226 patients will be enrolled, including up to 126
who had been enrolled in the CTH-300 efficacy study and rolled over to this
study, plus an additional 100 new patients.
For additional information about the CTH-301 trial and to learn
more about eligibility, patients can visit https://www.clinicaltrials.gov/
Anthony Giovinazzo, President and Chief Executive Officer of
Cynapsus, said, "Approximately 400,000 people with PD in the U.S.
experience debilitating OFF episodes. When PD patients experience an OFF
episode, they are often unable to perform simple daily tasks such as eating,
bathing and dressing, thus becoming increasingly dependent on caregivers. We
believe that APL-130277 can, if approved, change the way a large number of
patients around the world manage OFF episodes. While we expect to have 12 weeks
of safety data from the CTH-300 efficacy study in early to mid 2016, the
6-month data from the CTH-301 safety study will provide a much more robust
assessment of safety."
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 turning ON of debilitating OFF episodes
associated with PD. The Company recently completed a Phase 2 clinical trial for
its lead 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 a
new drug application in 2016.
Forward-Looking Statements
This announcement contains "forward-looking
statements" within the meaning of applicable securities laws, including,
without limitation, the expected completion of the CTH-300 and CTH-301 Phase 3
studies of APL-130277 in mid to late 2016, and an NDA submission of APL-130277
in 2016. 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-Q filed with the United States
Securities and Exchange Commission (the "SEC") on August 14, 2015 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: Company Contacts:
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
Investor Contact:
The Trout Group
Marcy Nanus
Senior Vice President
(646) 378-2927
mnanus@troutgroup.com
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com
http://health.einnews.com/article/284352825/GXuM9OrUjgFH0Wq9
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