HACKENSACK, N.J., Dec. 12 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. (Nasdaq: DOVP - News) announced today a positive futility analysis for DOV’s Phase III pivotal clinical trial in chronic low back pain (CLBP), meaning an external examination of interim trial data supports continuing the trial through to completion. Additionally, the Company continues to gather encouraging safety and efficacy data from its open label long term clinical trial of bicifadine in CLBP.
Positive Futility Analysis Outcome
DOV is conducting its first long term Phase III pivotal trial of bicifadine in CLBP. The trial is a U.S.-based, multi-center, double-blind study comparing three dose regimens of bicifadine (200, 300, 400 mg bid) to placebo administered for three months to patients with CLBP. A planned futility analysis was conducted by an independent external statistician after 300 patients had completed the trial.
The analysis of data on the improvement in pain scores from baseline to end of treatment -- the primary endpoint of the clinical trial -- indicates that bicifadine has at least a 40% chance of successfully meeting that endpoint and that the study should be continued to completion. DOV intends to release unblinded results from this pivotal Phase III trial in the second quarter of 2006.
Long Term Safety & Efficacy Trial of Bicifadine Continues to Yield Encouraging Data
As DOV reported at its Third Annual Scientific Symposium in October 2005, interim data from the Company’s open label long term trial of bicifadine in CLBP patients indicate that bicifadine is at least as effective as “standard of care” in treating CLBP, and is safe and well-tolerated. Patients in the standard of care group received an average of 2.5 drugs selected by their physician. Such drugs included narcotics, muscle relaxants and anti-inflammatory agents. The positive data trends reported in October have continued through to December, with dosing now spanning nine months and total patients enrolled in the trial exceeding 400.
DOV intends to provide a more detailed update regarding the safety and efficacy in this open label CLBP trial when it reports the data from its pivotal Phase III trial in CLBP, which is expected early in the second quarter of 2006. The Company reiterates that it believes sufficient safety data will be gathered by the end of 2006 to support the NDA filing in the first half of 2007.
“This has been a seminal year for DOV and we are looking forward to continuing to build on our momentum in the late-stage bicifadine program in 2006,” said Dr. Leslie Hudson, President and CEO of DOV. “Our Company is growing and our capabilities are expanding as we move into the later stages of development of bicifadine, which continues to show great promise as an effective analgesic. We are confident that the intended NDA filing for bicifadine in CLBP will be but the first step in bringing our clinical pipeline to the marketplace.”
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) financings that require SEC approval may be delayed. 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.
Source: DOV Pharmaceutical, Inc.