Cardiome Initiates Phase 1 Study for GED-aPC
20 November 2007 - 8:45PM
PR Newswire (US)
NASDAQ: CRME TSX: COM VANCOUVER, Nov. 20 /PRNewswire-FirstCall/ --
Cardiome Pharma Corp. (NASDAQ: CRME/TSX:NASDAQ:COM) today announced
initiation of subject dosing in its Phase 1 study of GED-aPC. The
single-blinded, placebo-controlled, dose-ranging study will measure
the safety, tolerability, pharmacokinetics and pharmacodynamics of
GED-aPC in 24 healthy subjects, with each subject receiving a
15-minute loading dose at the start of a 24-hour continuous
intravenous infusion of GED-aPC. Results from this study are
expected in the first half of 2008. "We are very pleased to
initiate our clinical program for GED-aPC, an exciting addition to
our clinical pipeline," stated Bob Rieder, Chairman and Chief
Executive Officer of Cardiome. "We believe strongly that GED-aPC
has the potential to be effective in treating a variety of
cardiovascular diseases, and intend to aggressively advance this
exciting new drug candidate through a rigorous clinical program."
GED-aPC is an engineered analog of recombinant human activated
Protein C (aPC) with enhanced anti-inflammatory, anti-thrombotic
and strong binding to endothelial protein C receptor properties,
and has broad potential across multiple indications. In April 2007
Cardiome acquired exclusive worldwide rights for GED-aPC for all
indications. Cardiome intends to initially develop GED-aPC in
cardiogenic shock, a life-threatening form of acute circulatory
failure due to cardiac dysfunction, which is a leading cause of
death for patients hospitalized following a heart attack. About
Cardiome Pharma Corp. Cardiome Pharma Corp. is a product-focused
cardiovascular drug development company with two late-stage
clinical drug programs focused on atrial arrhythmia (intravenous
and oral dosing), a Phase 1 program for GED-aPC, an engineered
analog of recombinant human activated Protein C, and a pre-clinical
program directed at improving cardiovascular function. Vernakalant
(iv) is the intravenous formulation of an investigational drug
being evaluated for the acute conversion of atrial fibrillation
(AF). Positive top-line results from two pivotal Phase 3 trials for
vernakalant (iv), called ACT 1 and ACT 3, were released in December
2004 and September 2005. Cardiome's co-development partner Astellas
Pharma US, Inc. submitted a New Drug Application for vernakalant
(iv) in December 2006. Positive top-line results from an additional
Phase 3 study evaluating patients with post-operative atrial
arrhythmia, called ACT 2, were released in June 2007. An open-label
safety study evaluating recent-onset AF patients, called ACT 4, has
completed. Vernakalant (oral) is being investigated as a
chronic-use oral drug for the maintenance of normal heart rhythm
following termination of AF. Cardiome announced positive results
from a Phase 2a pilot study for vernakalant (oral) in September
2006. A Phase 2b study for vernakalant (oral) is ongoing. In April
2007 Cardiome acquired exclusive worldwide rights for GED-aPC for
all indications. Cardiome intends to initially develop GED-aPC in
cardiogenic shock, a life-threatening form of acute circulatory
failure due to cardiac dysfunction, which is a leading cause of
death for patients hospitalized following a heart attack. Cardiome
is traded on the Toronto Stock Exchange (COM) and the NASDAQ
National Market (CRME). 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. CONTACT: Peter K. Hofman, Senior Director, Investor Relations,
(604) 676-6993 or Toll Free: 1-800-330-9928, Email: DATASOURCE:
Cardiome Pharma Corp. CONTACT: Peter K. Hofman, Senior Director,
Investor Relations, (604) 676-6993 or Toll Free: 1-800-330-9928,
Email:
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