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"While we remain blinded to the efficacy data from the ongoing study, wedo know that a significant proportion of our enrollment has occurred in thepast two months, meaning that those patients have not yet progressed deeplyinto the 90-day program," stated Doug Janzen, President and Chief BusinessOfficer of Cardiome. "By delaying one quarter we expect to add roughly 20percent more patients into the interim analysis than originally planned, andas a result more data will be available on patients with longer-term exposure.More than 400 patients have been randomized in the study, and enrollment isexpected to be complete in early 2008."
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"In the context of current business development activities and corporatediscussions, we have decided that generating a very robust interim analysiswith a large number of patients is in the best interests of shareholders,"stated Bob Rieder, Chairman and Chief Executive Officer of Cardiome. "While weare all looking forward to seeing data from this study as soon as possible, webelieve that the larger dataset that we can gather under this revised timelinewill be highly beneficial in our efforts to drive shareholder value in thefirst half of 2008. In accordance with our disclosure practice, we willrelease the results of the interim analysis in a timely manner upon receipt ofun-blinded results."
The Phase 2b clinical trial of vernakalant (oral) for the prevention ofrecurrence of atrial fibrillation was initiated in the first quarter of 2007.The double-blind, placebo-controlled, randomized, dose-ranging study isdesigned to measure the safety and efficacy of vernakalant (oral) over 90 daysof oral dosing in patients at risk of recurrent atrial fibrillation, and isexpected to enroll approximately 670 patients of which 500 to 600 are expectedto enter the maintenance phase and be measured for efficacy.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug developmentcompany with two late-stage clinical drug programs focused on atrialarrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, anengineered analog of recombinant human activated Protein C, and a pre-clinicalprogram directed at improving cardiovascular function.
Vernakalant (iv) is the intravenous formulation of an investigational drugbeing evaluated for the acute conversion of atrial fibrillation (AF). Positivetop-line results from two pivotal Phase 3 trials for vernakalant (iv), calledACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome'sco-development partner Astellas Pharma US, Inc. submitted a New DrugApplication for vernakalant (iv) in December 2006. Positive top-line resultsfrom an additional Phase 3 study evaluating patients with post-operativeatrial arrhythmia, called ACT 2, were released in June 2007. An open-labelsafety study evaluating recent-onset AF patients, called ACT 4, has completed.
Vernakalant (oral) is being investigated as a chronic-use oral drug forthe maintenance of normal heart rhythm following termination of AF. Cardiomeannounced positive results from a Phase 2a pilot study for vernakalant (oral)in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.
In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC forall indications. Cardiome intends to initially develop GED-aPC in cardiogenicshock, a life-threatening form of acute circulatory failure due to c
