HACKENSACK, N.J., Sept. 15 /PRNewswire-FirstCall/ -- DOV Pharmaceutical,
Inc. (Nasdaq: DOVP) announced today that it has initiated a third Phase III
clinical trial of bicifadine, its novel non-narcotic and non-NSAID analgesic,
in patients with moderate to severe chronic lower back pain. This pivotal
clinical trial is intended to support an NDA filing for the management of
chronic lower back pain. The first Phase III placebo-controlled pivotal
clinical trial was initiated in September 2004 and has achieved over 50%
enrollment to date. The Company expects to complete enrollment of this trial
by the end of 2005 and to complete dosing by March 2006. An interim futility
analysis of this trial is planned for completion in the fourth quarter of
2005. The second Phase III trial, a long-term safety study, was initiated in
December 2004 and will enroll up to 1,550 patients. Accumulated data from
this open label study will be reviewed at the Company's Third Annual
Scientific Symposium to be held in New York City on October 28, 2005.
This newly-initiated Phase III trial is a randomized, double-blind,
placebo-controlled, outpatient (600), multi-center study assessing the
efficacy and tolerability of three dose levels of bicifadine (200 mg b.i.d.,
400 mg b.i.d. and 400 mg t.i.d.) over a three-month period. Patients who
complete the study will be eligible for up to one year of additional treatment
in the follow-up safety study. The primary efficacy endpoint is a change in
pain severity rating as measured by the Visual Analog Scale between the start
and end of treatment. Secondary endpoints include changes in measures of
functional disability, patients' global impression of change, patient and
physician global evaluation of bicifadine, incidence of discontinuation due to
lack of efficacy, use of rescue medication and other analgesia-related rating
scales. Safety is being measured by adverse reaction occurrences, vital
signs, ECGs, clinical lab tests and other measures.
Dr. Warren Stern, senior vice president of drug development at DOV, said,
"The start of this Phase III clinical trial, and the additional clinical
studies that we plan to initiate by the end of 2005, are an indication of
DOV's confidence in the potential therapeutic benefits of bicifadine in the
treatment of chronic lower back pain. Currently, there is no approved drug
targeted specifically to this common and debilitating condition, thus creating
an excellent market opportunity for our company."
ABOUT BICIFADINE
Bicifadine is a chemically novel molecule with a unique profile of
pharmacological activity. Its primary pharmacological action is to enhance
and prolong the actions of norepinephrine and serotonin by inhibiting the
transport proteins that terminate their physiological actions. While the
Company believes that bicifadine also possesses additional neurochemical
properties that contribute to its analgesic effects, the exact nature of these
other properties is under investigation. Preclinical studies and clinical
trials indicate that either one or a combination of these individual actions
may account for the analgesic properties of bicifadine.
Bicifadine is not a narcotic and, in preclinical studies, it has been
shown not to act at any opiate receptor. In animal models, bicifadine does
not demonstrate abuse, addiction or dependence potential.
Bicifadine has demonstrated statistically significant analgesic effects in
three placebo-controlled clinical trials in patients with pain following third
molar dental and bunionectomy surgery, two models of moderate to severe acute
pain.
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, that 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 suspend one or more of our clinical trials, (iv) patient recruitment
may be slower than expected or patients may drop out of our clinical trials
including any future trial of ocinaplon if the present clinical hold is
lifted, (v) regulatory approval for our product candidates may not be received
or may be delayed, and (vi) performance of our licensees and collaborative
partners on whom our success depends may not fulfill their obligations to us.
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. 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.
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Related links:
http://www.dovpharm.com
CONTACT:
Barbara Duncan, Chief Financial Officer, or
Alan Beckhard, Manager, Investor Relations and Corporate
Communications, both of DOV Pharmaceutical, Inc., +1-201-968-0980
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