Cardiome Pharma Corp. said it would delay the phase IIb results of its oral atrial fibrillation drug vernakalant drug by 90 days. The company has decided to complete and disclose the interim analysis in March 2008, with the final study results to be presented in mid-2008. Cardiome had originally intended to complete and disclose the interim analysis in the fourth quarter of 2007.

The phase IIb clinical trial of vernakalant (oral) for the prevention of recurrence of atrial fibrillation was initiated in the first quarter of 2007. The double-blind, placebo-controlled, randomised, dose-ranging study is designed to measure the safety and efficacy of vernakalant over 90 days of oral dosing in patients at risk of recurrent atrial fibrillation, and is expected to enrol approximately 670 patients of which 500 to 600 are expected to enter the maintenance phase and be measured for efficacy.

"While we remain blinded to the efficacy data from the ongoing study, we do know that a significant proportion of our enrolment has occurred in the past two months, meaning that those patients have not yet progressed deeply into the 90-day program," said Doug Janzen, president and chief business officer, Cardiome. "By delaying one quarter we expect to add roughly 20 percent more patients into the interim analysis than originally planned, and as a result more data will be available on patients with longer-term exposure. More than 400 patients have been randomised in the study, and enrolment is expected to be complete in early 2008."

"In the context of current business development activities and corporate discussions, we have decided that generating a very robust interim analysis with a large number of patients is in the best interests of shareholders," stated Bob Rieder, Chairman and Chief Executive Officer of Cardiome. "While we are all looking forward to seeing data from this study as soon as possible, we believe that the larger dataset that we can gather under this revised timeline will be highly beneficial in our efforts to drive shareholder value in the first half of 2008. In accordance with our disclosure practice, we will release the results of the interim analysis in a timely manner upon receipt of un-blinded results."

Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two late-stage clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), a phase I programme for GED-aPC, an engineered analogue of recombinant human activated Protein C, and a pre-clinical program directed at improving cardiovascular function.

Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Positive top-line results from two pivotal phase III trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome's co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006. Positive top-line results from an additional phase III study evaluating patients with post-operative atrial arrhythmia, called ACT 2, were released in June 2007. An open-label safety study evaluating recent-onset AF patients, called ACT 4, has completed.

Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a phase IIa pilot study for vernakalant (oral) in September 2006. A phase IIb study for vernakalant (oral) is ongoing.

In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalised following a heart attack.