TARRYTOWN, N.Y., Jan. 22 /PRNewswire-FirstCall/ -- EpiCept Corporation today provided updates on the regulatory and clinical status of Ceplene(TM) (histamine dihydrochloride) and EpiCept(TM) NP-1 Cream.
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EpiCept announced today that its Marketing Authorization Application (MAA) seeking marketing approval for Ceplene in the European Union has advanced to the next important step. The Company has submitted full written responses to the Day 180 List of Outstanding Issues to the Committee for Human Medicinal Products (CHMP). With this response, EpiCept believes it has now addressed all outstanding issues related to the MAA.
The next regulatory milestone for Ceplene will be an Oral Explanation (OE) before all member states of the CHMP reviewing this MAA. The OE will be scheduled for later this quarter. Following this hearing, a recommendation on the approvability of Ceplene will be issued by the CHMP, which will be followed by a final decision by the European Commission.
EpiCept also said today that it expects to unblind and announce the results from its Phase II “Neuracept” trial for EpiCept NP-1 cream in patients suffering from diabetic peripheral neuropathy (DPN) in the near future. This study was designed to collect data on 200 patients; because 231 patients were randomized in this trial, slightly more time than was previously anticipated is required to compile and analyze the data.
About Ceplene
Ceplene is EpiCept’s registration-stage compound for the treatment of AML. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Laboratory research has demonstrated that Ceplene reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activated NK-cells and T-cells.
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 is 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.
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 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(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, the risk 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 we will not obtain approval to market any of our 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.
EPCT-GEN
*Azixa is a registered trademark of Myriad Genetics, Inc.
CONTACT: Robert W. Cook of EpiCept Corporation, +1-914-606-3500, or
rcook@epicept.com, or Media, Greg Kelley of Feinstein Kean Healthcare,
+1-617-577-8110, or gregory.kelley@fkhealth.com, for EpiCept Corporation,
or Investors, Kim Sutton Golodetz, +1-212-838-3777, or kgolodetz@lhai.com,
or Bruce Voss, +1-310-691-7100, or bvoss@lhai.com, both of
Lippert-Heilshorn & Associates, for EpiCept Corporation
Web site: http://www.epicept.com/
