Cardiome Announces Suspension of Enrollment in ACT 5 Trial
NASDAQ: CRME TSX: COM
VANCOUVER, Oct. 21 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.
The trial's independent Data Safety Monitoring Board (DSMB) has reviewed the case and recommended the trial continue, however the U.S. Food and Drug Administration (FDA) has requested that full data regarding this case from the South American clinical site be provided for their review prior to determining what steps, if any, are needed to restart the study.
"Patient safety has been and continues to be the primary concern of both Cardiome and Astellas," stated Doug Janzen, President and CEO of Cardiome. "We and Astellas will work closely with the clinical trial site, the DSMB and the FDA to review this serious adverse event, and seek to resume patient enrollment and treatment in the ACT 5 study as soon as it is appropriate to do so."
Conference Call
Cardiome will hold a teleconference and webcast on Thursday, October 21,
2010 at 9:00am Eastern (6:00am Pacific). To access the conference call,
please dial 416-695-7806 or 888-789-9572 and reference conference
3026546. There will be a separate dial-in line for analysts on which we
will respond to questions at the end of the call. The webcast can be
accessed through Cardiome's website at www.cardiome.com.
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through November 21, 2010. Please dial 416-695-5800 or 800-408-3053 and enter code 2430664# to access the replay.
About 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 470
patients across approximately 100 centres. 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 Pharma Corp.
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 Global Market (CRME) and the Toronto Stock Exchange
(COM). For more information, please visit our web site at www.cardiome.com.
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
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and factors that could cause such actual events or results expressed or
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risks, uncertainties and factors related to the fact that: we cannot
predict with certainty the outcome of regulatory reviews by the FDA;
we, together with our collaborative partners, may not be able to
successfully develop all or any of our current or future products and
may not be able to obtain regulatory approval in targeted indications
for our current or future products in all markets; we may not achieve
or maintain profitability; our future operating results are uncertain
and likely to fluctuate; we may not be able to raise additional capital
as and when required; we depend on our collaborative partners to
perform their obligations under licensing or other collaborative
agreements; 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; any of our
products that obtain regulatory approval will be subject to extensive
post-market regulation that may affect sales, marketing and
profitability; any of our products that are successfully developed may
not achieve market acceptance; we rely on third parties for the
continued supply and manufacture of our products and have no experience
in commercial manufacturing; we may face unknown risks related to
intellectual property matters, including with respect to our ability to
protect our intellectual property; 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 www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, 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.
Cardiome Investor Relations
(604) 676-6993 or Toll Free: 1-800-330-9928
Email: ir@cardiome.com