Cardiome Announces Positive Phase 2b Results For Oral Vernakalant

    TSX: COM

    VANCOUVER, July 14 /CNW/ - Cardiome Pharma Corp. (NASDAQ:   CRME /
TSX: COM) today announced positive clinical results from its 90-day Phase 2b
study of vernakalant (oral). The final analysis demonstrated statistically
significant efficacy for the patient group receiving 500mg b.i.d. of
vernakalant (oral) as compared to placebo. The safety data from the final
analysis also shows that vernakalant (oral) was well-tolerated in the atrial
fibrillation population studied.
    The final results demonstrated that the 500mg dosing group significantly
reduced the rate of atrial fibrillation relapse as compared to placebo
(two-sided log rank, p=0.0221). The median time to recurrence of atrial
fibrillation was greater than 90 days for the 500mg dosing group, compared to
27 days for the placebo group, an even stronger signal of sinus rhythm
maintenance than what was seen in the interim analysis. 51% of patients in the
500mg dosing group (n=150) completed the study in normal heart rhythm compared
to 37% of patients receiving placebo (n=160). Both the 150mg (n=147) and 300mg
(n=148) dosing groups also reduced the rate of atrial fibrillation relapse,
but were not statistically significant when compared with placebo. These
results provide evidence of a clear dose response, with 500mg b.i.d. proving
to be the effective dose to prevent the recurrence of atrial fibrillation in
this trial.
    "These statistically significant and clinically significant results
support and enhance the results we saw in the interim analysis and Phase 2a
study, while clearly demonstrating an appropriate dose to take forward into
the Phase 3 program," said Dr. Charles Fisher, Executive Vice President and
Chief Medical Officer of Cardiome. "Having observed more than a threefold
increase in median time to recurrence of atrial fibrillation in patients
receiving 500mg b.i.d. of vernakalant (oral), the potential therapeutic
benefit of vernakalant (oral) for patients at risk of recurrent atrial
fibrillation is clear."
    The safety data for all dosing groups indicates that vernakalant (oral)
was well-tolerated. There was no difference in the incidence of serious
adverse events between treatment groups. Potentially drug-related serious
adverse events occurred in 0.5% of placebo patients, 1.1% of patients in the
150mg dosing group, 0.5% of patients in the 300mg dosing group and 0.5% of
patients in the 500mg dosing group. There were no cases of "Torsades de
Pointes", a well-characterized arrhythmia which is a known side effect of some
current anti-arrhythmic drugs. There were 4 deaths in the study, all unrelated
to vernakalant (oral), comprising 2 patients in the placebo group, 1 patient
in the 150mg dosing group and 1 patient in the 300mg dosing group. There were
no deaths in the 500mg dosing group.
    "We are delighted to report clearly positive clinical results from our
vernakalant (oral) program, which continue to support our belief in the
exciting potential of vernakalant as a therapy for atrial fibrillation," said
Bob Rieder, Chairman and Chief Executive Officer of Cardiome. "With 949
patients and subjects exposed to vernakalant (oral) in this development
program, we now have an extensive safety and efficacy dataset to guide us as
we move this exciting clinical program forward and finalize our strategic
discussions with interested parties."
    The double-blind, placebo-controlled, randomized, dose-ranging study was
designed to explore safety and tolerability, pharmacokinetics and efficacy of
vernakalant (oral) over 90 days of dosing in patients at risk of recurrent
atrial fibrillation. Patients received a 150mg, 300mg or 500mg dose of
vernakalant (oral) or placebo twice per day. After the first 3 days, patients
still in atrial fibrillation were electrically cardioverted. Successfully
cardioverted patients continued to receive vernakalant (oral) or placebo for
the remainder of the 90-day trial and were monitored throughout the dosing
period. A total of 735 patients were randomized in the study, of which 605
were successfully cardioverted to sinus rhythm and entered the maintenance
phase and were evaluated for efficacy.
    Cardiome will hold a teleconference and webcast on Monday, July 14, 2008
at 9:00am Eastern (6:00am Pacific). To access the conference call, please dial
416-641-6117 or 866-299-6655. 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
    Webcast and telephone replays of the conference call will be available
approximately two hours after the completion of the call through August 14,
2008. Please dial 416-695-5800 or 800-408-3053 and enter code 3266465 followed
by the number sign to access the replay.

    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 National Market (CRME) and the Toronto Stock Exchange (COM). For more
information, please visit our web site at

    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 and the Canadian securities regulatory authorities at 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.

For further information:

For further information: Peter K. Hofman, Senior Director, Investor
Relations, (604) 676-6993 or Toll Free: 1-800-330-9928, Email:

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890