|P3b of IV vernakalant halted due to serious AE in South America.|
>>VANCOUVER, Oct. 21 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ:CRME - News) today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.
The trial's independent Data Safety Monitoring Board (DSMB) has reviewed the case and recommended the trial continue, however the U.S. Food and Drug Administration (FDA) has requested that full data regarding this case from the South American clinical site be provided for their review prior to determining what steps, if any, are needed to restart the study.
"Patient safety has been and continues to be the primary concern of both Cardiome and Astellas," stated Doug Janzen, President and CEO of Cardiome. "We and Astellas will work closely with the clinical trial site, the DSMB and the FDA to review this serious adverse event, and seek to resume patient enrollment and treatment in the ACT 5 study as soon as it is appropriate to do so."
Cardiome will hold a teleconference and webcast on Thursday, October 21, 2010 at 9:00am Eastern (6:00am Pacific). To access the conference call, please dial 416-695-7806 416-695-7806 or 888-789-9572 888-789-9572 and reference conference 3026546. 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 www.cardiome.com.
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through November 21, 2010. Please dial 416-695-5800 416-695-5800 or 800-408-3053 800-408-3053 and enter code 2430664# to access the replay.
About the ACT 5 Trial
The ACT 5 trial, "A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic Atrial Fibrillation," will enroll approximately 470 patients across approximately 100 centres. The study is designed to measure the safety and efficacy of KYNAPID Injection in patients with recent-onset atrial fibrillation (more than 3 hours but less than 7 days). The study excludes patients with evidence or history of congestive heart failure (CHF). Further, the study will evaluate the influence of CYP2D6 genotype status on the pharmacokinetics and pharmacodynamics of vernakalant (and its metabolites), and also allows for an exploratory analysis of safety and healthcare resource utilization between vernakalant and electrocardioversion (ECV). <<
Stock getting beat up some, had firesaled at one point, and is still close.
Apparently the patient survived. Nowhere do we get a ruling on whether or not this is drug related, except a vague go ahead from the DSMB.