Healthcare Industry News: Ceplene
News Release - July 23, 2007
EpiCept Announces Phase III Study of EpiCept(TM) NP-1 for the Treatment of Chemotherapy Induced Peripheral NeuropathyTARRYTOWN, N.Y., July 23 (HSMN NewsFeed) -- EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it will study EpiCept(TM) NP-1, its patented topical cream formulation of two FDA-approved drugs, 4% amitriptyline and 2% ketamine, for the treatment of chemotherapy induced peripheral neuropathy (CPN) in the ATTRACT-CPN Phase III Study (Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy). The study will be conducted within a network of approximately 25 sites under the direction of the National Cancer Institute (NCI) funded Community Clinical Oncology Program (CCOP).
Peripheral neuropathy, a painful condition caused by damage to the nerves in the peripheral nervous system, affects over 15 million people in the United States. CPN is the result of the toxicity of a number chemotherapeutic agents. The risk of neuropathy increases with cumulative exposure. The first symptoms are paresthesias, with dysesthesias occurring after a few courses of chemotherapy, and often followed by severe neuropathic pain.
The Study Chair, Professor Robert H. Dworkin stated, "I am pleased that EpiCept and the CCOP are working together to address this unmet medical need. CPN is becoming a more prevalent issue with the wider use of more active chemotherapeutic agents."
"We are excited that the NCI funded CCOP has chosen to conduct this clinical trial of EpiCept NP-1," remarked Jack Talley, President and Chief Executive Officer. "We believe the results of this study will build upon the body of clinical evidence which demonstrates the ability of NP-1 to provide long-term relief from the pain resulting from peripheral neuropathies."
The topical delivery mechanism of EpiCept NP-1 could provide important clinical advantages in treating CPN patients, including the reduction of systemic side effects and drug interactions.
The Phase III trial is expected to be initiated before the end of the third quarter of 2007. The double-blind, randomized placebo-controlled study will enroll approximately 400 patients suffering from painful CPN for at least 28 days following the conclusion of chemotherapy.
The trial will be 12 weeks in duration, with the primary endpoint being the change in average daily pain intensity scores from baseline to the end point. The secondary endpoints include the percentage of patients whose pain intensity decreases greater or equal to 30% from baseline and various other measures.
EpiCept NP-1 Clinical Development
EpiCept has initiated two additional Phase IIb trials for EpiCept NP-1, 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. Preliminary results are expected by the fourth quarter of 2007.
The second trial is a 500 patient, placebo- and active-controlled trial in peripheral herpetic neuropathy (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 trial. Preliminary results are expected in the first quarter of 2008.
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 is under review by the European Agency for the Evaluation of Medicinal Products (EMEA). 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.
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 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 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.
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