HACKENSACK, N.J., Feb. 6 /PRNewswire-FirstCall/ -. DOV Pharmaceutical, Inc. announced today that it has initiated dosing in a Phase II clinical trial of bicifadine, its novel analgesic, in patients with painful diabetic peripheral neuropathy. This is the first study of bicifadine in patients with neuropathic pain. The trial is a randomized, multiple-dose, open-label, two-phase overlap trial designed to assess the efficacy and safety of bicifadine and potential interactions of bicifadine and oxycodone used concurrently. DOV expects to complete dosing in the third quarter of this year.
The clinical trial will randomize 50 patients with painful diabetic neuropathy into two parallel four-week treatment groups. In this trial, patients will receive either bicifadine or oxycodone alone for two weeks and then both drugs in combination for the remaining two weeks. Analgesic efficacy will be determined at the end of each two-week period using patient scores on the Visual Analog Scale for pain -- the trial's primary endpoint. Secondary efficacy endpoints include patient ratings of global improvement and use of rescue medication.
"Preclinical studies of bicifadine show the drug has substantial analgesic effects in models of neuropathic pain in both diabetic animals and in animals with sensory neuron damage near the spinal cord," said Dr. Warren Stern, Senior Vice President of Drug Development. "Given the efficacy in preclinical neuropathic pain models and the encouraging efficacy data already collected in our open label Phase III clinical trial in chronic low back pain, we believe bicifadine could address the need for improved pain control in diabetic patients with painful neuropathy."
According to a July 2005 Datamonitor report, "Pipeline Insight: Neuropathic Pain" the neuropathic pain market has considerable unmet medical need and has been marked by the use of widely varying drug classes to treat patients. The report estimates the US and EU neuropathic pain markets at a combined total of $2.5 billion in 2005 and projects them to reach more than $4.1 billion by 2007.
Bicifadine is currently being evaluated in four Phase III clinical trials: three in Chronic Low Back Pain (CLBP) patients and one in patients suffering pain after vaginal hysterectomy. DOV intends to file its first NDA for bicifadine in CLBP in the first half of 2007. Phase III clinical trials have already demonstrated that bicifadine is effective in treating severe to moderate pain following dental surgery and bunionectomy.
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 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.
DOV Pharmaceutical, Inc.CONTACT: Keri P. Mattox, Director, Investor Relations and CorporateCommunications of DOV Pharmaceutical, Inc., +1-201-968-0980
Web site: http://www.dovpharm.com/
