HACKENSACK, N.J., Dec. 19 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. announced today that it has dosed the initial set of subjects in a second Phase Ib clinical trial of DOV 21,947, a novel antidepressant. This clinical trial is an important step in the development of DOV 21,947 and is designed to determine the likely upper limit dose to be used in the Phase II evaluation of efficacy and safety in depressed outpatients, planned to be initiated in the third quarter of 2006. A prior Phase Ib study in normal volunteers conducted by DOV evaluated the safety and pharmacokinetics of repeat doses of DOV 21,947. That trial indicated DOV 21,947 was well-tolerated and no dose-limiting side effects were seen.
This clinical trial is a double-blind, randomized, placebo-controlled study conducted in 28 normal volunteers. Subjects in the trial will receive single or multiple doses of DOV 21,947 or placebo for one week. Safety is being measured by adverse reaction occurrences, vital signs, ECGs, clinical lab tests and other measures.
DOV expects to complete dosing by the end of the first quarter of 2006 and anticipates reporting the results in the second quarter of 2006.
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 current antidepressants. This novel combination of properties in a single antidepressant could provide a breakthrough in the treatment of depression. Based upon preclinical studies, triple reuptake inhibitors such as DOV 21,947 have potential utility in treating a wide variety of central nervous system disorders including depression and obesity. DOV 21,947 is structurally related to DOV 216,303. DOV recently announced efficacy results from a Phase II clinical trial with DOV 216,303 for the treatment of depression. In that trial, patients who completed two weeks of treatment in both the DOV 216,303 and citalopram groups demonstrated reductions from baseline (p<0.0001) in the total HAM-D scores. In both groups, the reductions from baseline in the HAM-D scores were greater than 40%.
About DOV
DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular, which involve alterations in neuronal processing. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, pain, anxiety and depression. Our partner Neurocrine has filed two NDAs for the use of DOV’s compound indiplon for the treatment of 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, each as amended, including statements regarding our expectations with respect to the progress of and level of expenses for our clinical trial programs. 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. 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:
-- 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; -- Develop an acceptable development plan under and otherwise achieve the results contemplated by the recent amendment to the existing license agreement with Merck; -- Meet applicable regulatory standards and receive required regulatory approvals on our anticipated time schedule or at all; -- Meet obligations and required milestones under our license and other agreements; -- Obtain and maintain collaborations as required with pharmaceutical partners; -- Obtain substantial additional funds; -- Obtain and maintain all necessary patents or licenses; and -- Produce drug candidates in commercial quantities at reasonable costs and compete successfully against other products and companies.
Factors that may cause our actual results to differ materially from our forward-looking statements include (i) one or more of our product candidates could be shown to cause harmful side effects, (ii) one or more of our product candidates may not exhibit the expected therapeutic results, (iii) we or the FDA may place on clinical hold one or more of our clinical trials, and neither we nor the agency may determine to lift such hold, (iv) patient recruitment may be slower than expected or patients may drop out of our clinical trials, (v) regulatory approval for our product candidates may not be received or may be delayed, (vi) our licensees and collaborative partners on whom our success depends may not fulfill their obligations to us and (vii) required financings may be delayed or deferred owing to market conditions. You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission including those contained in our annual report on Form 10-K filed on March 15, 2005, and Form 10-Q filed on November 9, 2005. We qualify all our forward-looking statements by these cautionary statements. There may be other factors that may materially affect our forward-looking statements and our future results. Readers should not, therefore, place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.
DOV Pharmaceutical, Inc.
CONTACT: Alan Beckhard, +1-201-968-0980, Manager, Investor Relations andCorporate Communications, DOV Pharmaceutical, Inc.
Web site: http://www.dovpharm.com/
