Cardiome Announces Positive Phase 2b Results For Oral Vernakalant

VANCOUVER, July 14, 2008 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME /  TSX: COM) today announced positive clinical results from its 90-day Phase 2b  study of vernakalant (oral). The final analysis demonstrated statistically  significant efficacy for the patient group receiving 500mg b.i.d. of  vernakalant (oral) as compared to placebo. The safety data from the final  analysis also shows that vernakalant (oral) was well-tolerated in the atrial  fibrillation population studied.      

The final results demonstrated that the 500mg dosing group significantly  reduced the rate of atrial fibrillation relapse as compared to placebo  (two-sided log rank, p=0.0221). The median time to recurrence of atrial  fibrillation was greater than 90 days for the 500mg dosing group, compared to  27 days for the placebo group, an even stronger signal of sinus rhythm  maintenance than what was seen in the interim analysis. 51% of patients in the  500mg dosing group (n=150) completed the study in normal heart rhythm compared  to 37% of patients receiving placebo (n=160). Both the 150mg (n=147) and 300mg  (n=148) dosing groups also reduced the rate of atrial fibrillation relapse,  but were not statistically significant when compared with placebo. These  results provide evidence of a clear dose response, with 500mg b.i.d. proving  to be the effective dose to prevent the recurrence of atrial fibrillation in  this trial.      

"These statistically significant and clinically significant results  support and enhance the results we saw in the interim analysis and Phase 2a  study, while clearly demonstrating an appropriate dose to take forward into  the Phase 3 program," said Dr. Charles Fisher, Executive Vice President and  Chief Medical Officer of Cardiome. "Having observed more than a threefold  increase in median time to recurrence of atrial fibrillation in patients  receiving 500mg b.i.d. of vernakalant (oral), the potential therapeutic  benefit of vernakalant (oral) for patients at risk of recurrent atrial  fibrillation is clear."      

The safety data for all dosing groups indicates that vernakalant (oral)  was well-tolerated. There was no difference in the incidence of serious  adverse events between treatment groups. Potentially drug-related serious  adverse events occurred in 0.5% of placebo patients, 1.1% of patients in the  150mg dosing group, 0.5% of patients in the 300mg dosing group and 0.5% of  patients in the 500mg dosing group. There were no cases of "Torsades de  Pointes", a well-characterized arrhythmia which is a known side effect of some  current anti-arrhythmic drugs. There were 4 deaths in the study, all unrelated  to vernakalant (oral), comprising 2 patients in the placebo group, 1 patient  in the 150mg dosing group and 1 patient in the 300mg dosing group. There were  no deaths in the 500mg dosing group.      

"We are delighted to report clearly positive clinical results from our  vernakalant (oral) program, which continue to support our belief in the  exciting potential of vernakalant as a therapy for atrial fibrillation," said  Bob Rieder, Chairman and Chief Executive Officer of Cardiome. "With 949  patients and subjects exposed to vernakalant (oral) in this development  program, we now have an extensive safety and efficacy dataset to guide us as  we move this exciting clinical program forward and finalize our strategic  discussions with interested parties."      

The double-blind, placebo-controlled, randomized, dose-ranging study was  designed to explore safety and tolerability, pharmacokinetics and efficacy of  vernakalant (oral) over 90 days of dosing in patients at risk of recurrent  atrial fibrillation. Patients received a 150mg, 300mg or 500mg dose of  vernakalant (oral) or placebo twice per day. After the first 3 days, patients  still in atrial fibrillation were electrically cardioverted. Successfully  cardioverted patients continued to receive vernakalant (oral) or placebo for  the remainder of the 90-day trial and were monitored throughout the dosing  period. A total of 735 patients were randomized in the study, of which 605  were successfully cardioverted to sinus rhythm and entered the maintenance  phase and were evaluated for efficacy.       Cardiome will hold a teleconference and webcast on Monday, July 14, 2008  at 9:00am Eastern (6:00am Pacific). To access the conference call, please dial  416-641-6117 or 866-299-6655. There will be a separate dial-in line for  analysts on which we will respond to questions at the end of the call. The  webcast can be accessed through Cardiome's website at http://www.cardiome.com">www.cardiome.com.      

Webcast and telephone replays of the conference call will be available  approximately two hours after the completion of the call through August 14,  2008. Please dial 416-695-5800 or 800-408-3053 and enter code 3266645 followed  by the number sign to access the replay.   

About Cardiome Pharma Corp.   

Cardiome Pharma Corp. is a product-focused drug development company  dedicated to the advancement and commercialization of novel treatments for  disorders of the heart and circulatory system. Cardiome is traded on the  NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM). For more  information, please visit our web site at http://www.cardiome.com">www.cardiome.com.   

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  described in detail in our filings with the Securities and Exchange Commission  available at http://www.sec.gov">www.sec.gov and the Canadian securities regulatory authorities at  http://www.sedar.com">www.sedar.com. Given these risks and uncertainties, you are cautioned not to  place undue reliance on such forward-looking statements and information, which  are qualified in their entirety by this cautionary statement. All  forward-looking statements and information made herein are based on our  current expectations and we undertake no obligation to revise or update such  forward-looking statements and information to reflect subsequent events or  circumstances, except as required by law.   

For further information: Peter K. Hofman, Senior Director, Investor  Relations, (604) 676-6993 or Toll Free: 1-800-330-9928, Email:  phofman@cardiome.com">phofman@cardiome.com/

   


 

Posted: July 2008

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