EX-99.7 8 exhibit99-7.htm MATERIAL CHANGE REPORT - CARDIOME INITIATES PHASE 2A STUDY FOR ORAL RSD1235 Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - Exhibit 99.7

FORM 53-901F

SECURITIES ACT

MATERIAL CHANGE REPORT UNDER
SECTION 85(1) OF THE SECURITIES ACT (BRITISH COLUMBIA)
AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS

Item 1. REPORTING ISSUER
   
  Cardiome Pharma Corp.
  6190 Agronomy Road, 6th Floor
  Vancouver, BC V6T 1Z3
   
Item 2. DATE OF MATERIAL CHANGE
   
  December 9, 2005
   
Item 3. PRESS RELEASE
   
  December 9, 2005 - Vancouver, British Columbia
   
Item 4. SUMMARY OF MATERIAL CHANGE
   
   

Cardiome Pharma Corp. announced the initiation of a Phase 2a pilot study of oral RSD1235 for the prevention of recurrence of atrial fibrillation.

 

Item 5.

FULL DESCRIPTION OF MATERIAL CHANGE

 

           

Cardiome Pharma Corp. 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.

 

         

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.

 

   

Item 6.  

RELIANCE ON SECTION 85(2) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS

 

 

 

Not Applicable.  

 

 

Item 7.

OMITTED INFORMATION  

 

 

 

Not Applicable.  

 

   

Item 8.

SENIOR OFFICER  

 

 

 

Name:                                    Christina Yip

 

Title:                                      Vice President, Finance and Administration

 

Phone No.:                           604-677-6905

 

 

Item 9.

STATEMENT OF SENIOR OFFICER

 

 

 

The foregoing accurately discloses the material change referred to herein.

Dated at Vancouver, British Columbia, this 13th day of December, 2005.

  CARDIOME PHARMA CORP.
     
  Per:                    “Christina Yip”
    Christina Yip,
    Vice President, Finance and Administration

IT IS AN OFFENCE FOR A PERSON TO MAKE A STATEMENT IN A DOCUMENT REQUIRED TO BE FILED OR FURNISHED UNDER THE ACT OR THIS REGULATION THAT, AT THE TIME AND IN THE LIGHT OF THE CIRCUMSTANCES UNDER WHICH IT IS MADE, IS A MISREPRESENTATION.