This will hurt tomorrow. I'll miss the cc (if anyone cares to mention anythng noteworthy).
DOV Pharmaceutical, Inc. Places Ocinaplon Phase III Clinical Trial On Hold
Thursday August 25, 7:57 pm ET
HACKENSACK, N.J., Aug. 25 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc (Nasdaq: DOVP - News) announced today that it has suspended further dosing in the ongoing phase III clinical trial of ocinaplon, its novel anti-anxiety agent. This double-blind study had been intended to treat up to 373 healthy subjects and patients with generalized anxiety disorder with 60 mg/day of ocinaplon or placebo for four weeks. Approximately 200 subjects and patients have been randomized to treatment.
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The recent occurrence of enzyme elevations in liver function tests (LFTs) for one subject in this trial were of sufficient concern that DOV, in consultation with the independent data monitoring committee, decided to suspend the trial. This will enable DOV to unblind the study results and fully evaluate the safety findings from all subjects in the clinical trial. The data from the one subject could be an outlier or could represent a consistent adverse effect of the study drug. Several other subjects had elevations of LFTs but not to a degree sufficient to stop dosing. DOV has notified the U.S. Food and Drug Administration (FDA) of its actions and will provide the results of these interim analyses to the FDA.
DOV will continue to monitor the subjects and patients currently enrolled in the clinical trial and, upon full analysis and completion of its review, make a decision to continue with ocinaplon or select a back-up compound. DOV will consult with the FDA prior to any decision to resume dosing at the current level or with a reduced dosage regimen. This process is likely to take several months.
"While committed to moving forward with the development of ocinaplon, DOV is, first and foremost, dedicated to ensuring the safety of all participants in our clinical trials," said Dr. Warren Stern, Senior Vice President of Drug Development at DOV. "In addition to ocinaplon, DOV's active and ongoing GABA modulator program for the treatment of anxiety includes several late-stage preclinical candidates that could substitute for ocinaplon if required."
DOV will host a conference call on August 26, 2005 at 7:30 a.m. ET. The audio Web cast can be accessed at dovpharm.com under Investor Relations and will remain archived on the Web site for 90 days. The dial-in numbers for the live teleconference are as follows: (Toll Free) 1-877-407-8031 and (International): 1-201-689-8031. A full replay of the conference call will be available through September 2, 2005. The replay can be accessed by dialing: (Toll Free) 1-877-660-6853 and (International): 1-201-612-7415 and entering account # 286 and conference ID# 167030. |
