Cardiome Receives Approval To Commence Phase II Study.Business Editors VANCOUVER, B.C.--(BUSINESS WIRE)--Oct. 19, 2001 Cardiome Pharma Corp. (the "Company") (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :COMTF) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :COM.) announced today that it has received approval from the U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and Canadian Therapeutic Product Directorate (TPD) to begin a Phase II study of RSD1235, a novel candidate for the treatment of atrial fibrillation (AF). The approvals followed submission of IND (Investigational New Drug) applications in both the US and Canada. "This is a landmark study in our antiarrhythmic antiarrhythmic /an·ti·ar·rhyth·mic/ (-ah-rith´mik) 1. preventing or alleviating cardiac arrhythmias. 2. an agent that so acts. an·ti·ar·rhyth·mic adj. development programme," said Dr. Alan Ezrin, Cardiome's Chief Scientific Officer. "We are pleased to have authorization to begin this study, and to be working with globally recognized cardiologists in several centres in both Canada and the US." Dr. Denis 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. and Dr. Bramah Singh of the UCLA School of Medicine serve as co-chairs for the study steering committee. The 60-patient Phase II trial is a randomized, placebo-controlled, double-blind, step-dose study in patients with recent onset atrial fibrillation. The primary end point will be conversion of atrial fibrillation within 30 minutes of infusion. The Company has engaged a contract clinical research organization, CroMedica Global Inc., to oversee the study in up to 20 centres in the U.S. and Canada. Enrolment of patients will commence in November 2001. The study is expected to be completed within six months, with final results due in Q3, 2002. "This trial is designed to provide unequivocal evidence regarding the effectiveness of our drug candidate," added Dr. Ezrin. "If RSD1235 meets our expectations, it will revolutionize the management of patients with AF." Atrial fibrillation is a condition in which the atria or storage chambers of the heart beat rapidly and erratically. Left untreated, the condition can cause stroke or ultimately, 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. . Approximately 7.6 million patients in the developed world (US, Europe, Japan) suffer occasionally or chronically from atrial fibrillation. About 3.2 million acute cases are reported each year in the developed world. It is estimated that the market for an IV drug to treat such acute cases approaches US$300 million per year while chronic oral dosing of RSD1235 in an extended release form could access a market estimated at approximately US$3 billion. Cardiome Pharma Corp. is a cardiac drug discovery and development company. Its current focus is on prevention and treatment of cardiac arrhythmia, with three programs in that area. In addition to the RSD1235 acute-use program, Cardiome's RSD1122 program is focused on a chronic use antiarrhythmic. RSD1122 is licensed to AstraZeneca, one of the world's largest pharmaceutical companies. Cardiome's Kv1.5 program, also focused on treatment of atrial arrhythmia, is in the pre-clinical phase. The Company is based at the University of British Columbia Locations Vancouver The Vancouver campus is located at Point Grey, a twenty-minute drive from downtown Vancouver. It is near several beaches and has views of the North Shore mountains. The 7. in Vancouver, 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 NASD NASD See: National Association of Securities Dealers NASD See National Association of Securities Dealers (NASD). BB market (COMTF). On Behalf of the Board Robert Rieder, President & Chief Executive Officer The foregoing news release contains 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. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion