EpiCept Corporation to Present New NP-1 Data at American Pain Society Meeting |
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By: EpiCept Corporation Posted: 2007-05-03 08:23:53 |
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EpiCept Corporation (Nasdaq and OMX Stockholm: EPCT) announced today that it will present new data for EpiCept(TM) NP-1 on Thursday, May 3, 2007 at the 26th Annual Scientific Meeting of the American Pain Society in Washington D.C. EpiCept NP-1 is a patented topical cream formulation of two FDA-approved drugs, 4% amitriptyline and 2% ketamine. NP-1 is a product candidate intended for use in the management of pain resulting from various peripheral neuropathies. Two studies will be presented in poster format by Dennis Everton, RPh., Director of Clinical Development.
Results from a new human pharmacokinetic study of NP-1 designed to assess the pharmacokinetic parameters as well as its safety and tolerability will be presented. The highest observed level of amitriptyline at any time point was 5.91 ng/mL. The highest observed level of ketamine at any time point was 10.7 ng/mL. These levels are far below any known systemic efficacy level and even further below any known systemic level associated with adverse reactions. The study found that NP-1 was safe and well tolerated across all age groups studied. The low systemic levels of amitriptyline and ketamine indicated a local mechanism of action rather than a systemic one. NP-1 is intended as additive therapy in neuropathic pain. This study confirms the independent topical mechanism of NP-1. Findings will also be presented from a previously disclosed multicenter, double-blind, randomized, placebo controlled Phase II study of NP-1 in treating post-herpetic neuralgia (PHN) in 118 patients. The study was designed to evaluate the analgesic properties of two different strengths of NP-1 compared with placebo in the treatment of PHN. The study met its primary endpoint of an improvement in pain intensity for the high dose strength vs. placebo from baseline to day 21 (p=0.026). Additionally, the study met the following secondary endpoints: a responder analysis of improvement in pain intensity (p<0.025), a responder analysis of improvement in pain relief (p<0.01), improvement in patient sleep scores (p=0.028) and overall patient global satisfaction (p=0.04). This study also found that significant neuropathic pain relief was achieved at a small fraction of the plasma levels observed after systemic dosing. The cream was found to be safe and well tolerated across all age groups studied. "These findings add to a growing body of clinical data which demonstrate the potential for NP-1 to provide effective, additive, long-term relief to the 15 million Americans who suffer from the pain of peripheral neuropathies. The outcome from the pharmacokinetic trial in particular supports the safety of NP-1 topical cream and even more importantly its ability to be added to orally administered therapies," remarked Jack Talley, President and CEO of EpiCept. "We believe NP-1 has the largest market potential of any of our pain product candidates and we are focused on advancing it through its current Phase IIb trials. These trials are progressing as expected and we remain on track to be able to share preliminary results from the first trial by the fourth quarter of 2007. "Current systemically-delivered analgesics have well documented limitations and significant potential side effects. The local mechanism of action of NP-1 demonstrated in these studies could reduce these side effects by blocking pain directly at its source," remarked Stephane Allard, MD, Chief Medical Officer. EpiCept NP-1 is currently undergoing two Phase IIb trials, enrolling a total of 700 patients. The first trial is a 200 patient, placebo-controlled study of NP-1 in patients with diabetic peripheral neuropathy (DPN). More patients suffer from DPN than any other type of neuropathic pain. Only two medications are currently approved for this use. The trial is intended to confirm and expand upon earlier work which provided an efficacy signal in this type of neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. The second trial is a 500 patient, placebo- and active-controlled trial in PHN. This trial will compare the efficacy and safety of NP-1 vs. gabapentin as well as placebo. This active comparator trial is one of the first such efforts to examine any candidate compound at this scale in neuropathic pain. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. EpiCept's Approach to Treating Pain EpiCept's pain product candidates are designed to topically deliver FDA- approved pain management therapeutics directly to the surface of the skin, thereby blocking the ability of peripheral nerve receptors to transmit pain messages to the brain, providing significant pain relief, with fewer adverse side effects, fewer drug to drug interactions and lower potential for abuse than systemically delivered analgesics. About EpiCept Corporation EpiCept is focused on unmet needs in the treatment of pain and cancer. EpiCept has a staged portfolio of pharmaceutical product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound has been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis. Forward-Looking Statements 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 Myriad's development of Azixa 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 the clinical trials for NP-1 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, 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 reliance on additional outside financing to meet its capital requirements, 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 our ability to have our common stock readmitted to trading on The Nasdaq Global Market; 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 |
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