Top-line data expected in early 2008
TARRYTOWN, N.Y., Dec. 3 /PRNewswire-FirstCall/ -- EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has completed patient enrollment in the Phase IIb "Neuracept" trial for EpiCept(TM) NP-1 cream. EpiCept NP-1 is a patented topical cream formulation of two FDA- approved drugs, 4% amitriptyline and 2% ketamine, and is intended to provide long-term relief from the pain of peripheral neuropathies.
This Phase IIb trial compares the active ingredients in NP-1 against placebo in patients suffering from diabetic peripheral neuropathy (DPN), the most common form of neuropathic pain. Only two medications are currently available in the United States for the treatment of DPN. The four-week, 200- patient trial is intended to confirm and expand upon earlier work that provided a preliminary efficacy signal in this type of neuropathic pain. The primary endpoint for the Phase IIb trial is the difference between active and placebo changes in pain intensity from baseline compared to the average over the last seven days of treatment.
"We are pleased to have reached another key clinical milestone that we established for 2007, and to have advanced another one of our product candidates," stated Jack Talley, President and Chief Executive Officer of EpiCept. "We believe NP-1 holds the largest market potential of the pain candidates in our portfolio. Treatment of neuropathic pain is a billion dollar opportunity. We believe that NP-1 has the potential to become a new and efficacious topical treatment without the inherent systemic side effects of alternative treatments for the 15 million Americans who suffer from peripheral neuropathies. We expect to report top-line results from this trial in early 2008."
In addition to the NP-1 trial in DPN, there are two other clinical
trials for NP-1 currently underway.
-- A Phase III trial in chemotherapy-induced peripheral neuropathy (CPN)
is being conducted by the National Cancer Institute (NCI)-funded
Community Clinical Oncology Program. The double-blind, randomized
placebo-controlled study includes approximately 400 patients suffering
from painful CPN for at least 28 days following the conclusion of
chemotherapy. The primary endpoint of the 12-week trial is change in
average daily pain intensity scores from baseline to the endpoint.
This trial is currently enrolling patients.
-- A Phase IIb trial is underway in peripheral herpetic neuropathy. This
500-patient, placebo- and active-controlled trial will compare the
efficacy and safety of NP-1 vs. gabapentin and placebo. The primary
endpoint for this trial is the change in pain intensity over the four-
week duration of the trial. Preliminary results are expected early in
the second quarter of 2008.
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 includes several pain therapies in clinical development and a lead oncology compound for AML with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound is approaching a decision in Europe. In addition, EpiCept's ASAP technology, a proprietary live cell high- throughput caspase-3 screening technology, can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells. Two oncology drug candidates currently in clinical development that were discovered using this technology have also been shown to act as vascular disruption agents in a variety of solid tumors.
This news release and any oral statements made with respect to the information contained in this news release, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on EpiCept's current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that our NP-1 clinical trials will not be successful, that NP-1 will not receive regulatory approval or achieve significant commercial success, the risk that Ceplene will not receive regulatory approval or marketing authorization in the EU or that Ceplene, if approved, will not achieve significant commercial success, the risk that Myriad's development of Azixa(TM) will not be successful, the risk that Azixa will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myriad, the risk that the development of our other apoptosis product candidates will not be successful, the risk that our ASAP technology will not yield any successful product candidates, the risk that clinical trials for EPC 2407 will not be successful, that EPC 2407 will not receive regulatory approval or achieve significant commercial success, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that EpiCept will not obtain approval to market any of its product candidates, the risks associated with our need to raise additional financing to continue to meet our capital needs and our ability to continue as a going concern, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; competition; litigation; risks associated with prior material weaknesses in our internal controls; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in EpiCept's periodic reports, including its reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in EpiCept's filings which are available at http://www.sec.gov or at http://www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
* Azixa is a registered trademark of Myriad Genetics, Inc.
|SOURCE EpiCept Corporation|
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