TORONTO, Aug. 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), announced today that its
Data Safety and Monitoring Board (DSMB) has completed a review of
the safety data from the Company's Phase 3 program including both
the CTH-300 and CTH-301 clinical trials. Based on the DSMB's
recommendations, the CTH-300 trial will continue as planned. In
addition, as a result of the DSMB's review of the early safety data
from both CTH-300 and CTH-301, the six-month open label CTH-301
study will be amended to allow for at-home titration, after the
patient's initial visit to the clinic.
The DSMB is an independent body of experts drawn
from the fields of clinical medicine biostatistics and trial
methodology, which functions under a charter approved by the U.S.
Food and Drug Administration (FDA) to review the accumulated data
of Cynapsus' clinical trial and to provide recommendations to the
Company.
"We are very pleased with the DSMB's positive
recommendations to assess an amendment to allow at-home dose
titration in the CTH-301, six-month open label safety study," said
Anthony Giovinazzo, President and CEO of Cynapsus.
"This decision is based upon the positive safety
signal seen during titration in the CTH-300 double-blind 12-week
efficacy study. Allowing the trial to proceed with the modification
for at-home titration is expected to make it more convenient for PD
patients to treat their OFF episodes. We believe this change may
assist with patient compliance and allow Cynapsus to assess results
in a more real-world setting," said Dr. Albert Agro, Chief Medical
Officer of Cynapsus.
Phase 3 Program Study
Design
The CTH-300 study is a double-blind,
placebo-controlled, parallel-design, two-part study. The
study has enrolled eligible PD patients and 102 PD patients have
entered the Open Label dose titration phase (DTP). In the DTP,
patients arrived at the clinic in the practically defined OFF state
(withholding their morning dose of PD medications) and received the
lowest dose of APL-130277 (10mg). Patients were assessed to
determine if successful conversion from OFF to full ON occurred. If
a full ON was not achieved, patients returned to the clinic on
subsequent visits and received a higher dose of APL-130277 (at 5mg
increments, up to 35mg) until the effective conversion dose was
identified. Those patients that turned fully ON with a dose of
APL-130277 during the DTP proceeded to the dose randomization part
of the study where they were randomized to receive either the
effective dose or placebo. The objective of the second part of
CTH-300 is to evaluate the efficacy, safety and tolerability of
APL-130277 versus placebo in patients with PD over a 12-week
period. CTH-300 is well powered to demonstrate statistical
significant reduction in MDS-UPDRS Part III with 80 patients
randomized. A sample size of 80 randomized patients allows for
greater than 90% power to achieve statistical significance at the
primary and key secondary endpoint. The primary endpoint is a
mean change in the MDS-UPDRS Part III score at 30 minutes after 12
weeks of at-home dosing.
The CTH-301 Phase 3 Safety Study (CTH-301) is a
long-term open-label, single arm safety study involving PD patients
who have at least one OFF episode per day, with total OFF time of
at least two hours per day. The objective of CTH-301 is to evaluate
the safety and tolerability of APL-130277 in up to 200 patients
with PD over a six-month period. Patients completing CTH-300
are eligible to enter CTH-301. In addition, de novo patients from
approximately 65 sites in North America and Europe will be enrolled
in CTH-301.
Data from CTH-300 and CTH-301 are expected to form
the basis for the registration package necessary for a 505(b)(2)
New Drug Application (NDA) with the FDA expected to be submitted in
the first half of 2017.
About Cynapsus
Cynapsus is a specialty 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 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 expects to submit an
NDA in the first half of 2017. For additional company information,
please visit our website at www.cynapsus.ca. For more
information about the Phase 3 studies, including enrollment
criteria, please visit the following
website: 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 in the first half of 2017; expectations regarding the
Company's clinical and regulatory activities, including without
limitation, the anticipated timing, completion and results of Phase
3 and other clinical studies; beliefs related to potential benefits
and effectiveness of, and demand for, the Company's product
candidate; and expectations relating to at-home titration and the
impact on the Company's clinical trials. 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 10, 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
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com
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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