SOURCE: DOV Pharmaceutical, Inc.

February 28, 2008 13:09 ET

DOV Pharmaceutical, Inc. Initiates Phase II Clinical Trial in Patients With Major Depressive Disorder

SOMERSET, NJ--(Marketwire - February 28, 2008) - DOV Pharmaceutical, Inc. (OTCBB: DOVP) announced today that it has initiated a Phase II clinical trial of DOV 21,947 in patients diagnosed with major depressive disorder. DOV 21,947 is DOV's lead triple reuptake inhibitor, or "TRIP," for the treatment of depression and obesity. The clinical trial, which will randomize approximately 200 patients, is a double-blind, placebo-controlled, multi-center study assessing the efficacy and safety of DOV 21,947 over a six-week period. The primary endpoint of the study is the change in the Montgomery-Asberg Depression Rating Scale from baseline to end of treatment in evaluable patients. DOV expects to announce study results as early as the fourth quarter of 2008.

"After obtaining encouraging results in our recently completed eight-week safety study of DOV 21,947, which demonstrated both weight loss and lowered plasma triglyceride levels in drug-compliant subjects, we amended the design of this study to ensure that we are capturing the potential effects of DOV 21,947 on body weight and appropriately capturing drug-compliance data in our analyses," said Dr. Phil Skolnick, president and chief scientific officer. "Both preclinical and clinical evidence to date support our belief that as a TRIP, DOV 21,947 may provide efficacy greater than SSRIs and SNRIs currently prescribed for the treatment of depression. In addition to efficacy in animal models of depression, the clinical data for DOV 21,947 suggests an improved side-effect profile, including potential stabilization or reduction in body weight."

About DOV 21,947

Clinical and preclinical research indicates that drug combinations, which inhibit reuptake of all three neurotransmitters most closely linked to depression, serotonin, norepinephrine and dopamine, can produce greater overall efficacy than currently marketed antidepressants. A single antidepressant that could produce such triple reuptake inhibition would represent a breakthrough in the treatment of depression. DOV 21,947, a TRIP, is structurally related to DOV 216,303. In a previously reported Phase II clinical trial, DOV 216,303 was administered to patients suffering from major depressive disorder. After two weeks of treatment, patients treated with DOV 216,303 demonstrated reductions (p < 0.0001) in the total HAM-D scores comparable to control patients treated with citalopram. In both groups, the reductions from baseline in the HAM-D scores were greater than 40%.

In seven Phase I studies, DOV 21,947 was observed to be safe and well tolerated. In addition, the dosages for this clinical study are comparable to those used in the most recent eight-week study in which statistically significant weight loss was observed in drug-complaint subjects.

About DOV

DOV is a biopharmaceutical company focused on the acquisition and development of novel drug candidates for central nervous system disorders. The Company's product candidates address some of the largest pharmaceutical markets in the world including depression, pain and insomnia.

Cautionary Note

Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain or even relatively confident. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:

--  raise substantial additional capital in order to fund operations;
--  obtain and maintain all necessary patents, licenses and other
    intellectual property rights;
--  demonstrate the safety and efficacy of product candidates at each
    stage of development;
--  meet our development schedule for our product candidates, including
    with respect to clinical trial initiation, enrollment and completion;
--  meet applicable regulatory standards and receive required regulatory
    approvals on our anticipated time schedule or at all;
--  meet or require our partners to meet obligations and achieve
    milestones under our license and other agreements;
--  obtain and maintain collaborations as required with pharmaceutical
    partners; and
--  produce drug candidates in commercial quantities at reasonable costs
    and compete successfully against other products and companies.
    

You should also refer to the risks discussed in our filings with the Securities and Exchange Commission including those contained in our annual report on Form 10-K for the fiscal year ended December 31, 2006 that was filed on March 30, 2007 and our quarterly reports on Form 10-Q that were filed on May 15, 2007, August 8, 2007 and November 7, 2007. We qualify all our forward-looking statements by these cautionary statements. Readers should not place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.

Contact Information

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    DOV Pharmaceutical, Inc.
    Investor Relations
    732-907-3600
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