DEERFIELD, IL, and VANCOUVER, March 25 /CNW/ - Astellas Pharma US, Inc.
and its co-development partner Cardiome Pharma Corp. announced the first
pivotal Phase III study evaluating the investigational agent KYNAPID(TM)
(vernakalant hydrochloride) Injection was published today in Circulation, the
official journal of the American Heart Association.
In the study, known as the Atrial arrhythmia Conversion Trial (ACT I),
the primary efficacy analysis showed that 75 of the 145 (51.7%) KYNAPID
patients in the short-duration atrial fibrillation (AF) group (3 hours to 7
days) converted to sinus rhythm within 90 minutes compared with 3 of the
75(4.0%) placebo patients. Patients with AF lasting 3 to 48 hours who received
KYNAPID demonstrated the highest conversion rate (62.1%) compared with 4.9%
with placebo. The median time to conversion to sinus rhythm for the 75
patients receiving KYNAPID who converted was 11 minutes. Only 1 of the 75
KYNAPID-treated patients who converted to sinus rhythm relapsed to AF at
"Due to the importance of treating AF quickly, we're pleased that KYNAPID
displayed such a rapid conversion of AF to sinus rhythm," said Edward
Pritchett, MD, Consulting Professor of Medicine, Divisions of Cardiology and
Clinical Pharmacology, Duke University Medical Center and consultant for
Astellas Pharma US.
About ACT I
The Phase III study, referred to as ACT I, was a prospective, randomized,
double-blind, placebo-controlled trial of hemodynamically stable patients with
symptomatic AF or nontypical atrial flutter, conducted at 44 sites in Canada,
the United States and Scandinavia. The study assessed the safety and efficacy
of KYNAPID for the conversion of AF. Results of the study showed KYNAPID
demonstrated rapid conversion of short-duration AF and was well tolerated.
The efficacy and safety evaluable populations included 220 patients in
the short-duration AF group and 116 patients in the long-duration AF group.
Patients with AF were randomly assigned in a 2:1 ratio to KYNAPID 3 mg/kg or
placebo infused over 10 minutes. After 15 minutes, a second 10 minute infusion
of KYNAPID 2 mg/kg or placebo was given if AF persisted or atrial flutter was
present. The primary efficacy measure was the percentage of patients
demonstrating conversion to SR for at least one minute within 90 minutes of
dosing in the short-duration AF group.
The most common adverse events (AEs) reported within the first 24 hours
in patients given KYNAPID were taste disturbance (29.9%), sneezing (16.3%),
skin sensation (10.9%), nausea (9%), and hypotension (6.3%). These events were
generally transient. Four serious AEs possibly or probably related to KYNAPID
occurred in three patients and included hypotension (2 events), complete
atrioventricular block and cardiogenic shock.
About Atrial Fibrillation
AF is an interruption of the normal sinus rhythm (arrhythmia) of the
heart in which the atria, the two uppermost chambers of the heart, beat
irregularly and at an extremely rapid rate. During AF, rapid and uncoordinated
electrical discharges are generated by the heart's natural pacemaker
(sinoatrial node) and other parts of the atria. This causes ineffective
contractions of the atria and reduces the ability of the heart to pump blood
through the body. Symptoms include dizziness, heart palpitations, weakness,
shortness of breath and angina (chest pain). AF is the most common cardiac
arrhythmia. AF patients are three to five times more likely to develop stroke,
and 15% of stroke cases are attributed to AF. The number of AF patients is
expected to triple over the next 50 years due to the increased prevalence of
risk factors including hypertension, obesity, diastolic dysfunction,
inflammation, diabetes and sleep apnea.
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 US,
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 www.astellas.com/us.
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. 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
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Given these risks and uncertainties, you are cautioned not to place undue
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qualified in their entirety by this cautionary statement. All forward-looking
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For further information:
For further information: Maribeth Landwehr, Astellas US LLC, (847)
317-8988; Katherine Williams, Weber Shandwick, (312) 397-6613; Peter K.
Hofman, Senior Director, Investor Relations, Cardiome Pharma Corp., (604)
676-6993 or Toll Free: 1-800-330-9928, Email: email@example.com