TARRYTOWN, N.Y., Dec. 3 EpiCept Corporation(Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has completedpatient enrollment in the Phase IIb "Neuracept" trial for EpiCept(TM) NP-1cream. EpiCept NP-1 is a patented topical cream formulation of two FDA-approved drugs, 4% amitriptyline and 2% ketamine, and is intended to providelong-term relief from the pain of peripheral neuropathies.
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This Phase IIb trial compares the active ingredients in NP-1 againstplacebo in patients suffering from diabetic peripheral neuropathy (DPN), themost common form of neuropathic pain. Only two medications are currentlyavailable in the United States for the treatment of DPN. The four-week, 200-patient trial is intended to confirm and expand upon earlier work thatprovided a preliminary efficacy signal in this type of neuropathic pain. Theprimary endpoint for the Phase IIb trial is the difference between active andplacebo changes in pain intensity from baseline compared to the average overthe last seven days of treatment.
"We are pleased to have reached another key clinical milestone that weestablished for 2007, and to have advanced another one of our productcandidates," stated Jack Talley, President and Chief Executive Officer ofEpiCept. "We believe NP-1 holds the largest market potential of the paincandidates in our portfolio. Treatment of neuropathic pain is a billiondollar opportunity. We believe that NP-1 has the potential to become a newand efficacious topical treatment without the inherent systemic side effectsof alternative treatments for the 15 million Americans who suffer fromperipheral neuropathies. We expect to report top-line results from this trialin early 2008."
In addition to the NP-1 trial in DPN, there are two other clinical trialsfor NP-1 currently underway.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer.The Company's broad portfolio of pharmaceutical product candidates includesseveral pain therapies in clinical development and a lead oncology compoundfor AML with demonstrated efficacy in a Phase III trial; a marketingauthorization application for this compound is approaching a decision inEurope. In addition, EpiCept's ASAP technology, a proprietary live cell high-throughput caspase-3 screening technology, can efficiently identify new cancerdrug candidates and molecular targets that selectively induce apoptosis incancer cells. Two oncology drug candidates currently in clinical developmentthat were discovered using this technology have also been shown to act asvascular disruption agents in a variety of solid tumors.
This news release and any oral statements made with respect to theinformation contained in this news release, contains forward-lookingstatements within the meaning of the Private Securities Litigation Reform Actof 1995. Such forward-looking statements include statements which expressplans, anticipation, intent, contingency, goals, targets, future developmentand are otherwise not statements of historical fact. These statements arebased on EpiCept's current expectations and are subject to risks anduncertainties that could cause actual results or developments to be materiallydifferent from historical results or from any future results expressed orimplied by such forward-looking statements. Factors that may cause actualresults or developments to differ materially include: the risk that our NP-1clinical trials will not be successful, that NP-1 will not receive regulatoryapproval or achieve significant commercial success, the risk that Ceplene willnot receive regulatory approval or marketing authorization in the EU or thatCeplene, if approved, will not achieve significant commercial success, therisk that Myriad's development of Azixa(TM) wi