Cardiome And Astellas Announce Initiation Of Patient Enrolment In ACT 5 Trial
28 Outubro 2009 - 6:58PM
PR Newswire (US)
NASDAQ: CRME TSX: COM VANCOUVER and DEERFIELD, IL, Oct. 28
/PRNewswire-FirstCall/ -- Cardiome Pharma Corp.
(NASDAQ:CRME/TSX:NASDAQ:COM) and its co-development partner
Astellas Pharma US, Inc. ("Astellas") announced today that patient
enrolment has begun for the ACT 5 trial, a confirmatory Phase 3
clinical trial of KYNAPID(TM) (vernakalant hydrochloride)
Injection, a drug product candidate under development for the rapid
conversion of atrial fibrillation to sinus rhythm. The ACT 5 trial,
previously announced in August 2009, is expected to be completed in
the first half of 2011. The ACT 5 Trial The ACT 5 trial, "A Phase
3b Randomized, Double-Blind, Placebo Controlled, Parallel Group
Study to Evaluate the Safety and Efficacy of Vernakalant
Hydrochloride Injection in Patients with Recent Onset Symptomatic
Atrial Fibrillation," will enroll approximately 450 patients across
approximately 100 centres focused in North America. The study is
designed to measure the safety and efficacy of KYNAPID Injection in
patients with recent-onset atrial fibrillation (more than 3 hours
but less than 7 days). The study excludes patients with evidence or
history of congestive heart failure (CHF). Further, the study will
evaluate the influence of CYP2D6 genotype status on the
pharmacokinetics and pharmacodynamics of vernakalant (and its
metabolites), and also allows for an exploratory analysis of safety
and healthcare resource utilization between vernakalant and
electrocardioversion (ECV). About Cardiome Cardiome Pharma Corp. is
a product-focused drug development company dedicated to the
advancement and commercialization of novel treatments for disorders
of the heart and circulatory system. Cardiome is traded on the
NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM).
For more information, please visit our web site at
http://www.cardiome.com/. About Astellas Astellas Pharma US, Inc.,
located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based
Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated
to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. The
organization is committed to becoming a global category leader in
focused areas by combining outstanding R&D and marketing
capabilities. In the U.S., Astellas markets products in the areas
of Immunology, Urology, Anti-Infectives, Cardiovascular and
Dermatology. For more information about Astellas Pharma US, Inc.,
please visit our website at http://www.us.astellas.com/. Cardiome
Forward-Looking Statement Disclaimer Certain statements in this
press release contain forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 or
forward-looking information under applicable Canadian securities
legislation that may not be based on historical fact, including
without limitation statements containing the words "believe",
"may", "plan", "will", "estimate", "continue", "anticipate",
"intend", "expect" and similar expressions. Such forward-looking
statements or information involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
events or developments, or industry results, to be materially
different from any future results, events or developments expressed
or implied by such forward-looking statements or information. Such
factors include, among others, our stage of development, lack of
product revenues, additional capital requirements, risk associated
with the completion of clinical trials and obtaining regulatory
approval to market our products, the ability to protect our
intellectual property, dependence on collaborative partners and the
prospects for negotiating additional corporate collaborations or
licensing arrangements and their timing. Specifically, certain
risks and uncertainties that could cause such actual events or
results expressed or implied by such forward-looking statements and
information to differ materially from any future events or results
expressed or implied by such statements and information include,
but are not limited to, the risks and uncertainties that: we may
not be able to successfully develop and obtain regulatory approval
for vernakalant (iv) or vernakalant (oral) in the treatment of
atrial fibrillation or any other current or future products in our
targeted indications; our future operating results are uncertain
and likely to fluctuate; we may not be able to raise additional
capital; we may not be successful in establishing additional
corporate collaborations or licensing arrangements; we may not be
able to establish marketing and sales capabilities and the costs of
launching our products may be greater than anticipated; we rely on
third parties for the continued supply and manufacture of
vernakalant (iv) and vernakalant (oral) and we have no experience
in commercial manufacturing; we may face unknown risks related to
intellectual property matters; we face increased competition from
pharmaceutical and biotechnology companies; and other factors as
described in detail in our filings with the Securities and Exchange
Commission available at http://www.sec.gov/ and the Canadian
securities regulatory authorities at http://www.sedar.com/. Given
these risks and uncertainties, you are cautioned not to place undue
reliance on such forward-looking statements and information, which
are qualified in their entirety by this cautionary statement. All
forward-looking statements and information made herein are based on
our current expectations and we undertake no obligation to revise
or update such forward-looking statements and information to
reflect subsequent events or circumstances, except as required by
law. DATASOURCE: Cardiome Pharma Corp. CONTACT: Peter K. Hofman,
Senior Director, Investor Relations, Cardiome Pharma Corp., (604)
676-6993 or Toll Free: 1-800-330-9928, Email: ; Jenny Keeney,
Astellas US LLC, (847) 317-5405
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