Cynapsus Announces Positive Opinion from Data and Safety Monitoring Board on Phase 3 Parkinson's Disease Clinical Study Allowing for At-Home Titration
(Thomson Reuters ONE) -
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(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#2035231]
Unternehmensinformation / Kurzprofil:
Datum: 15.08.2016 - 12:00 Uhr
Sprache: Deutsch
News-ID 489144
Anzahl Zeichen: 9462
contact information:
Town:
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Kategorie:
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