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DOV 21,947 Demonstrates Significant Body Weight and BMI Reductions in Drug- Compliant Subjects in Phase Ib Clinical Study
Date:9/25/2007

SOMERSET, N.J., Sept. 25 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. ("DOV", or the "Company") (OTCBB and Pink Sheets: DOVP) announced today additional Phase Ib results for DOV 21,947, its lead triple reuptake inhibitor ("TRIP") for the treatment of depression and obesity. A preliminary analysis of the study results demonstrated that DOV 21,947 was safe and well-tolerated at the doses examined, and produced a statistically significant reduction in plasma triglyceride levels, as described more fully below. Further analyses of these data demonstrate that DOV 21,947 significantly reduces body weight and Body Mass Index ("BMI") in drug-compliant subjects compared to placebo. The Company intends to initiate a Phase II study of DOV 21,947 for the treatment of depression in the first quarter of 2008.

This double-blind, placebo-controlled Phase Ib study enrolled 46 male and female volunteers. Following a one-week placebo run-in, subjects received either escalating daily doses of 50 mg, 100 mg and 150 mg of DOV 21,947 (31 subjects) or placebo (15 subjects), for a total of eight weeks. Those subjects with detectable blood levels of DOV 21,947 or its principal metabolite during at least three of four bimonthly visits (approximately 70% of the drug-treated subjects) were classified as drug compliant.

At the end of this eight-week study, the mean difference in body weight change from baseline between the drug-compliant and placebo groups was 4.6 pounds (p<0.006). Furthermore, following a one-week wash-out period, this highly significant difference in body weight change between the groups was reduced by almost 50%, indicating a reversible, drug-related effect. Statistical results similar to those for the body weight reduction were obtained for the BMI. The mean difference in BMI change from baseline between the drug-compliant and placebo groups was 0.75 kg/m2 (p<0.005), with a reversible drug-related effect at the end of the one-week wash-out period.


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SOURCE DOV Pharmaceutical, Inc.
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