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Cardiome Drug Effective for Heart Patients.


Business Editors & Health/Medical Writers

BERLIN--(BUSINESS WIRE)--Sept. 3, 2002

Cardiome Pharma Corp. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:COMRF) (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
:COM) today announced that its atrial fibrillation drug, RSD RSD Reflex sympathetic dystrophy, see there 1235, met both primary and secondary endpoints in a recent phase 2 clinical study. The placebo-controlled study demonstrated that RSD1235 is effective in terminating atrial fibrillation and in converting atrial fibrillation to normal heart rhythm.

The results were presented by Dr. Denis Denis, king of Portugal: see Diniz.  Roy, of the Montreal Heart Institute The Montreal Heart Institute (French: Institut de Cardiologie de Montréal), in Montreal, Quebec, is a specialty hospital dedicated to the development of cardiology. Founded in 1954, it is currently affiliated with the Université de Montréal. , during the 2002 Congress of the European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe.  in Berlin. In a satellite symposium to the Berlin conference, Dr. Roy reported that during the 30-minute post-dosing observation interval, 11% of the low-dose group and 61% of the high-dose group experienced termination of atrial fibrillation against a placebo rate of 5%. At the end of the 24-hour post-dosing observation interval, 100% of the high-dose patients whose arrhythmia was terminated remained in normal sinus rhythm. In the high-dose group, the average time to termination was 22 minutes from initiation of dosing. No significant drug-related adverse events were reported.

"RSD1235 appears to be a highly effective drug for treatment of atrial fibrillation. The conversion rate of RSD1235 is exciting, and the drug appears to be very well tolerated," said Dr. Roy at the meeting. "In addition, its fast onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring.  may make RSD1235 attractive to physicians treating patients with atrial fibrillation."

Trial Results

The clinical trial was structured as a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, placebo-controlled, double-blind, step-dose study in patients with recent onset atrial fibrillation. The study included 56 patients with a diagnosis of atrial fibrillation of duration greater than 3 hours and less than 72 hours who were randomized to receive placebo, RSD1235 at a low dose or RSD1235 at a high dose. The primary endpoint was the ability of RSD1235 to terminate atrial fibrillation within 30 minutes of infusion. Secondary endpoints included observation of heart rhythm at 30 minutes, 1 hour and 24 hours post-infusion. The termination rate in the low-dose group relative to placebo was not statistically significant. The termination rate in the high-dose group was statistically significant (p-value less then 0.001). RSD1235 was well tolerated at both the low and high dose and no drug related arrhythmias were observed.


Primary Endpoint: Termination of Atrial Fibrillation

Group       Patients     Termination (30 min.)     p-value vs placebo
----------------------------------------------------------------------
Placebo        19                  1(5% )                  NA
Low Dose       18                  2(11%)                  NS
High Dose      18                 11(61%)            P less then 0.001



As secondary endpoints, the study measured whether or not patients were in normal sinus rhythm ("NSR NSR
abbr.
normal sinus rhythm


NSR Normal sinus rhythm, see there
") at 30 minutes, 1 hour and 24 hours post dosing. Of the 11 patients whose AF was terminated, 10 remained in normal sinus rhythm at all secondary endpoints. The high-dose group was statistically significant relative to placebo (p-value less then 0.001) at the 0.5 and 1 hour time points.

"This clinical success represents a very important transition point for Cardiome," said Bob Rieder, Cardiome's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "It proves that we have a promising drug candidate in our hands, and clearly demonstrates our ability to identify and develop drugs in the cardiovascular area. We also expect that this exciting data will attract the attention of potential pharma industry partners, and will enable the company to raise the funds required to build our product pipeline."

"We are optimistic that we are on a path that will give acute atrial fibrillation patients a safer, more effective and less intrusive treatment than what is available today," said Dr. Alan Ezrin, Cardiome's Chief Scientific Officer. "The success of this trial directly reflects the creativity, expertise and commitment of Cardiome's staff and of our outstanding team of independent clinical investigators led by Dr. Roy."

Dr. Ezrin said Phase III clinical trials would begin in 2003 and would be designed to enable Cardiome to apply for marketing approval for RSD1235 in 2006.

The value of the pharmaceuticals used to treat atrial fibrillation exceeds U.S.$1 billion annually in the developed world and is growing with the increasing age of the general population. However, these existing antiarrhythmic drugs have serious side effects that limit their use. A product that is both safe and effective could significantly penetrate the existing market and potentially expand the market by offering treatment to patients who cannot tolerate existing therapies.

RSD1235 is specifically targeted to acute atrial fibrillation. Its mechanism of action involves blockade of cellular electrical currents that play a causative role in atrial fibrillation. Pre-clinical studies showed that RSD1235 is effective against atrial arrhythmia and has few side effects. In phase 1 human clinical testing, no significant adverse events were observed at dosing levels equal to the maximum doses used in the reported phase 2 study.

Notification of Conference Call and Webcast


Time:  12:30 p.m. (EST)
Date:  Tuesday September 3, 2002
Topic: Top Line Results of RSD1235
Web Access (unlimited access): www.cardiome.com
Telephone Access: 416-695-5806



About Cardiome Pharma Corp.

Cardiome Pharma Corp. is a product-focused company developing drugs targeted at unmet needs in the treatment of cardiovascular disease, the largest pharmaceutical market sector in the world. Cardiome has three active programs focused on cardiovascular disease, as well as a program applying its congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time.  drug to symptomatic hyperuricemia hyperuricemia /hy·per·uri·ce·mia/ (-u?ri-se´me-ah) uricemia; an excess of uric acid in the blood.hyperurice´mic

hy·per·u·ri·ce·mi·a
n.
An unusually high concentration of uric acid in the blood.
 (gout). Results of a phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study.  released September 3, 2002 indicated Cardiome's lead antiarrhythmia product, RSD1235, is effective in the treatment of patients with recent-onset acute atrial fibrillation. Cardiome's lead CHF CHF

In currencies, this is the abbreviation for the Swiss Franc.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
 product is Oxypurinol, for which a phase 2 clinical trial is expected to begin in the second half of 2002. Cardiome has more than two years of cash at existing spending levels and is traded on the Toronto Stock Exchange Toronto Stock Exchange (TSE)

Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options.
 (COM) and the NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 bulletin board (COMRF). Further information about Cardiome can be found at www.cardiome.com.

Forward-Looking Statement Disclaimer

Statements contained in this news release relating to future results, events and expectation are forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, among others, those described in the Company's annual report on Form 20-F. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

ON BEHALF OF THE BOARD

Robert Rieder, President & Chief Executive Officer
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1CANA
Date:Sep 3, 2002
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