Inc. ("DOV", or the "Company") (OTCBB and Pink Sheets: DOVP) announced 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
"The delay in the initiation of the Phase II study of DOV 21,947 to the
first quarter of 2008 has enabled us to further evaluate the protocol
design to ensure that we are capturing potential effects of DOV 21,947's
effects on body weight and appropriately capture drug-compliance in our
analyses. This delay, along with other cost containment measures, also
serves to provide us with sufficient capital through April 2008 as we
explore our financing and collaborative options," said Barbara Duncan,
Chief Executive Officer of DOV. The double-blind, Phase II study now
scheduled for initiation in the first quarter of 2008 will compare up to
100 mg per day of DOV 21,947 versus placebo in approximately 200 patients
with major depressive disorder over a six-week treatment period. The
Company expects the results from this Phase II study to be available at the
end of 2008.
About DOV 21,947
Clinical research indicates that co-administrating drugs that, in
combination, inhibit reuptake of the three neurotransmitters most closely
linked to depression - serotonin, norepinephrine and dopamine - can produce
greater overall efficacy than currently marketed antidepressants. This
novel combination of properties in a single antidepressant could provide a
breakthrough in the treatment of depression. DOV 21,947, a TRIP, is
structurally related to DOV 216,303. In a Phase II clinical trial with DOV
216,303 for the treatment of depression, patients who completed two weeks
of treatment in both the DOV 216,303 and citalopram groups demonstrated
reductions from baseline (p
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