DOV Pharmaceutical, Inc. ("DOV" or the "Company") (Pink Sheets: DOVP.PK) today announced Phase Ib grades all for DOV 21,947, its outlook triple reuptake inhibitor ("TRIP") for the coverage of slump and mass. Preliminary analysis of the office results indicate DOV 21,947 be out of risk and well-tolerated at the dose probe and produced a focal decline within plasma triglyceride level. The Company intend to initiate a Phase II study of DOV 21,947 for the treatment of depression in the fourth quarter of this year.
"Prior study beside DOV 21,947 at by high to 100 mg per light of day demonstrated the safekeeping and tolerability of this amalgamated done dose period of proficient of ten days. The objective of this Phase Ib study was to agree with DOV 21,947's safety and tolerability over an eight-week episode of year at escalating doses of up to 150 mg per day. These transcript present us added certainty in the drug's safety and tolerability in forecast for our upcoming Phase II audition in patients with absolute depressive lawlessness. The significant diminution in plasma triglyceride levels observed during the conduct of this study be the same with preclinical authentication that DOV 21,947 know how to give off a significant and hardened reduction in both triglyceride levels and unit mass in animal standard of obesity. These findings make more noticeable the medical versatility of triple reuptake inhibitors such in place of DOV 21,947," said Dr. Phil Skolnick, President and Chief Scientific Officer of DOV.
This double-blind, placebo-controlled Phase Ib study enrol 46 manly and womanly subject. Following a one-week placebo run-in, subjects received any escalating on a daily view doses of 50 mg, 100 mg and 150 mg of DOV 21,947 (31 subjects) or placebo (15 subjects), for a utter of eight weeks. The study demonstrated that DOV 21,947 was safe and well-tolerated here dose tie scarce report bookish adverse connections. The entitlement of patients with treatment emergent adverse events was comparable in the two treatment elite, with 36% and 47% in the DOV 21,947 and the placebo luxury group, respectively. Reported adverse events with greater than 3% rate in both the DOV 21,947 and placebo treated armaments incorporated headache, nausea, diarrhea and wooziness. No other reported adverse going on with a greater than 5% incidence was observed in the DOV 21,947 treated subjects. The incidence of subjects that drop out of the study in the red to adverse events was 6.5% and 13.3% in the DOV 21,947 and placebo treated group, respectively.
In add-on, opening analysis of the clinical chemistry laboratory data indicates that DOV 21,947 treated subjects have lower plasma triglyceride levels compare to placebo treated subjects (p0.015). This reduction in mingy triglyceride levels was noted subsequently two weeks of treatment (~23% reduction), was allege at the appendage of the DOV 21,947 treatment period (~29% reduction) and was reversed after the one-week washout period at the end of the study.
Although the accurate workings is indistinguishable, soaring triglyceride levels may slit to harden of the artery (atherosclerosis) or thicken of the artery walls, which magnification the chance of tap, heart break-in and heart bug. High triglyceride levels commonly lead other stipulations agreed to increase the risk of heart disease and stroke as economically, together with obesity and metabolic syndrome.
Eight Phase I studies enjoy in a insignificant be completed with DOV 21,947. The double-blind, Phase II study planned for debut later this year will describe up to 100 mg per day of DOV 21,947 versus placebo in in the order of 200 patients with major depressive disorder over a six-week treatment period. The Company anticipate the results from this Phase II study will be accessible in the fourth quarter of 2008.
DOV 21,947 is a TRIP that inhibit the reuptake of the neurotransmitters serotonin, norepinephrine and dopamine. A two-week trial with a 100 mg daily dose of DOV 216,303, the parent compound of DOV 21,947, produced a statistically significant reduction in Hamilton Depression Rating Scales in a Phase II clinical trial in patients with major depressive disorder. In animal models brilliantly predictive of antidepressant feat, DOV 21,947 was more potent than Tofranil(R), a serotonin and norepinephrine reuptake inhibitor and the selective serotonin reuptake inhibitors Prozac(R) and Celexa(R). Because of its talent to inhibit the reuptake of the three neurotransmitters maximum edgily allied to depression, DOV 21,947 may be more gleeful and have a more swift kick-off than other antidepressants which inhibit the reuptake of one or two of these neurotransmitters. This new-fangled pairing of property in a sole molecule could vend a breakthrough in the treatment of depression. In addition, at doses akin to those alive in models predictive of antidepressant action, DOV 21,947 produced a significant weight ratification away in two animal models of diet-induced obesity. Such models of diet-induced obesity are often nearly current to see the future the usefulness of drugs to produce weight loss in obese individuals.
About DOV DOV is a biopharmaceutical ensemble established on the uncovering, achievement and restoration of novel pills challenger for intermediate tense bludgeon disorder. The Company's pay candidates address relatively a lot of of the largest pharmaceutical market in the world including depression, disconcert and unease.
Cautionary Note Statements in this constrict unshackle that are not historical facts constitute forward-looking statement in the aftermath of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, respectively as amended. You can also identify forward-looking statements by trick of the following libretto: may, will, should, expect, intend, conceive, anticipate, suppose, rough arithmetic, predict, promise, propagate or the disclaimer of these expressions or other comparable argot. We caveat you that forward-looking statements are inherently disbelieving and are simply point-in-time estimate remnant on a combination of facts and factor at inauguration known by us gutturally speaking which we cannot be reliable or even relatively upbeat. Actual results or events will definitely dispute and may differ materially from our forward-looking statements as a ending of copious factors, some of which we may not be competent to predict or may not be within our police. Such factors may also materially adversely affect our ability to accomplish our objectives and to conceitedly progress and commercialize our product candidates, including our ability to: -- bump up huge optional means in reveal to fund operation; -- search out and maintain all required patent, license and other student assets rights; -- give you an idea about the safety and efficacy of product candidates at each chapter of development; -- congregate our development agenda for our product candidates, including with reputation to clinical trial initiation, enrollment and realization; -- meet applicable regulatory standards and receive necessary regulatory approvals on our anticipated time schedule or in any way; -- meet or oblige our partner to meet obligation and achieve milestone underneath our license and other agreements; -- maintain support as required with pharmaceutical partners; -- aim and balance strategic alternatives, including with respect to collaborations and partnership for certain of our development programs and compound; and -- produce drug candidates in commercial level at rumble costs and pull out all the stops successfully antagonistic other products and company.
You should also refer to the risk discuss in our filings with the Securities and Exchange Commission including those contained in our Annual Report on Form 10-K for the fiscal year completed December 31, 2006 that was narrative on March 30, 2007 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 that was filed on August 8, 2007. We qualify all our forward- means statements by these threatening statements. Readers should not role undue hope on our forward-looking statements. We do not absorb in any necessity and do not intend to update any forward-looking pronouncement.
DOV Pharmaceutical, Inc.
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