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Arena's 2007 Highlights
-- Initiated BLOSSOM and BLOOM-DM, the second and third Phase 3 pivotal
trials evaluating the efficacy and safety of Arena's lead drug
candidate, lorcaserin hydrochloride, or lorcaserin, for the treatment
of obesity. These one-year, double-blind, randomized and
placebo-controlled trials are expected to collectively enroll
approximately 3,750 overweight and obese patients. Consistent with
Arena's proposal, the US Food and Drug Administration, or FDA, has
allowed Arena to eliminate the requirement to perform
echocardiographic testing prior to enrolling patients in both BLOSSOM
and BLOOM-DM. This is different from the design of BLOOM, the initial
lorcaserin pivotal study, in which echocardiography was used to screen
for patients with FDA-defined valvulopathy, and certain other
echocardiographic abnormalities, and exclude those patients from
enrolling in the trial.
-- Completed a public offering of 11.0 million shares of common stock at
$9.91 per share, resulting in net proceeds to Arena of approximately
$103.2 million.
-- Announced positive preliminary results from Arena's Phase 2a clinical
trial of APD125 in patients with chronic insomnia. In this Phase 2a
clinical trial, APD125 significantly improved endpoints measuring
improvements in sleep maintenance with no observations of next day
cognitive impairment.
-- Reported that an independent Echocardiographic Safety Monitoring Board
found no reason to stop the ongoing pivotal Phase 3 lorcaserin BLOOM
trial following a planned review of unblinded echocardiograms
performed after patients completed six months of dosing in the trial.
The review confirmed that differences, if any, in the rates of
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| SOURCE Arena Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved |