- Additional Phase 3 Trials on Track for Initiation Later This Year -
- Conference Call Scheduled for Today at 8:30 a.m. Eastern Time -
SAN DIEGO, Sept. 11 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that an independent Echocardiographic Data Safety Monitoring Board (the Board or EDSMB) found no reason to stop the ongoing pivotal Phase 3 trial, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management). The BLOOM trial is evaluating the efficacy and safety of lorcaserin hydrochloride for the treatment of obesity. The findings of the Board were based on a planned detailed review of unblinded echocardiograms performed after patients completed six months of dosing in the trial. The review was conducted by the Board and confirms that differences, if any, in the rates of U.S. Food and Drug Administration (FDA)-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet predetermined stopping criteria. The review also confirmed that the rate of FDA-defined valvulopathy in the placebo group is consistent with the company's statistical powering assumptions used in the design of the pivotal trial program to monitor patients for any increased risk of developing valvulopathy. Arena is currently in discussions with the FDA to finalize protocols for two additional Phase 3 pivotal trials scheduled to begin later this year.
"Patient safety is and always has been a primary focus for Arena in our
effort to fully explore and understand lorcaserin's profile and its
potential to safely help a significant number of patients that are obese or
overweight improve their health by better managing their weight," said Jack
|SOURCE Arena Pharmaceuticals|
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