EpiCept Announces Encouraging Results of Phase II Trial for NP-1 Cream in Diabetic Peripheral Neuropathy
Results Support Advancement to Pivotal Phase III DPN Testing
TARRYTOWN, N.Y.--Feb. 7, 2008--EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced preliminary results from its Phase II "Neuracept" trial for EpiCept(TM) NP-1 Cream in patients suffering from diabetic peripheral neuropathy (DPN). All pain scores measured trended in favor of the NP-1 treated patients over the placebo group, indicative of an analgesic effect in this type of peripheral neuropathic pain. EpiCept has concluded that preliminary data derived from the trial support the continued study of NP-1 in a late-stage pivotal clinical trial.
The Neuracept trial was a double blind, placebo-controlled study of NP-1 in 215 DPN patients who completed the trial. The data demonstrated that the primary endpoint, the difference in changes in pain intensity between NP-1 and placebo over the four week duration of the trial, nearly reached statistical significance (p=0.0715) in this Phase II study. It is clear that the analgesic benefits of NP-1 continued to build over time during the course of the study. Key secondary endpoints measured in the trial from a responder analysis indicate that 60% of patients in the NP-1 treatment arm achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo arm (p=0.076). In addition, 33% of patients in the NP-1 treatment arm achieved a reduction in pain scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078).
"We believe this clinical trial successfully demonstrated proof of concept of NP-1 in DPN. The consistent analgesic trends we observed in this Phase II trial warrant advancement into a pivotal Phase III registration trial," stated Jack Talley, President and CEO of EpiCept. "This is the first trial EpiCept conducted solely with patients suffering from DPN, and given the consistent efficacy trend we saw, this Phase II trial will give us key insights to design and power an appropriately sized Phase III trial in peripheral diabetic neuropathic pain. We undertook this trial to broaden the data set for use in upcoming licensing discussions, and we expect the results to generate additional interest and enthusiasm in NP-1 as a potential treatment for a broad variety of neuropathic pain conditions."
Dr. Robert H. Dworkin, Principal Clinical Consultant for the trial, from the University of Rochester School of Medicine and Dentistry commented, "The completer analysis from this placebo-controlled study demonstrated a clear trend in favor of a beneficial effect of NP-1 in diabetic peripheral neuropathy. In my view the drug merits continued study in pivotal Phase III trials."
"The trial demonstrated the clinical significance of NP-1 as a treatment for DPN," stated Stephane Allard, MD, Chief Medical Officer of EpiCept Corporation. "The results are very encouraging, especially for such a difficult indication to study. With this data and the data from our earlier Phase II trials, we are able to move forward with the design of a pivotal Phase III clinical trial program intended to lead to an NDA filing for NP-1 in the treatment of neuropathic pain."
EpiCept NP-1 is currently being studied in two additional clinical trials: a Phase III trial in chemotherapy-induced peripheral neuropathy (CPN) which is being conducted by the National Cancer Institute (NCI)-funded Community Clinical Oncology Program; and a Phase IIb comparative trial vs. gabapentin and placebo in post-herpetic neuralgia (PHN). EpiCept anticipates completing enrollment for the PHN trial in the second quarter of 2008. A Phase II trial of NP-1 for the treatment of post-herpetic neuralgia reported in 2007 at the American Pain Society meeting demonstrated a statistically significant change in pain intensity between NP-1 and placebo over the three week duration of the trial.
About EpiCept NP-1
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. Peripheral neuropathies are medical conditions caused by damage to the nerves in the peripheral nervous system. The peripheral nervous system includes nerves that run from the brain and spinal cord to the rest of the body. It is estimated that these conditions affect more than 15 million people in the U.S. and are associated with conditions that injure peripheral nerves, including herpes zoster or shingles, diabetes, chemotherapy, HIV and other diseases.
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 the proposed public offering will not be consummated, 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 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 will not be successful, the risk that Azixa(TM) 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 NP-1 or EPC 2407 will not be successful, that NP-1 or 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 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 www.sec.gov or at 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.
Posted: February 2008