[FYI] Cardiome initiates Phase 2a study for oral RSD1235

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Friday December 9, 11:47 am ET

VANCOUVER, Dec. 9 /PRNewswire-FirstCall/ - Cardiome Pharma Corp.

(NASDAQ: CRME / TSX: COM) today announced the initiation of a Phase

2a pilot study of oral RSD1235 for the prevention of recurrence of

atrial fibrillation. The double-blind, placebo-controlled,

randomized, dose-ranging study will measure the safety and efficacy

of oral RSD1235 over 28 days of oral dosing in patients at risk of

recurrent atrial fibrillation. It is expected that the majority of

patients enrolled will have experienced atrial fibrillation for

greater than 30 days and less than 180 days in duration. The study

will enroll 180 patients across 75 centres in Canada, U.S. and

Europe.

Patients with atrial fibrillation in the first stage of the study

will receive a 300mg dose of oral RSD1235 or placebo twice per day.

After the first 3 days, patients still in atrial fibrillation will

be electrically cardioverted. Successfully cardioverted patients

will continue to receive oral RSD1235 or placebo for the remaining

25 days and will be monitored throughout the dosing period. Multiple

safety and preliminary efficacy parameters will be measured. Interim

results from the study for the 300mg dosing group are expected in

mid-2006. Final results including data from a 600 mg twice daily

dose in the second stage will be available by the end of 2006.

Cardiome anticipates initiating a Phase 2b study of oral RSD1235 in

the second half of 2006.

" We are excited to initiate the next stage of our oral RSD1235

development program. " stated Bob Rieder, President and CEO of

Cardiome. " This Phase 2a study will provide us with valuable data to

help us advance this clinically and commercially exciting program. "

In August 2005, Cardiome announced the successful completion of a

series of Phase 1 studies evaluating the pharmacokinetics, safety

and tolerability of orally-administered RSD1235, which was found to

be safe and well-tolerated across all dose levels explored. The

maximum dose given for 7 days was 900mg twice daily (1,800mg/day),

yielding blood levels of RSD1235 approaching peak blood levels seen

in IV dosing. The formulation provided sustained high blood levels

of drug over an interval deemed suitable for chronic-use oral

therapy. No clinically relevant changes were found in clinical

laboratory, vital signs or ECG measurements, and there were no

serious adverse events.