ENGLEWOOD CLIFFS, N.J., Nov. 1 /PRNewswire-FirstCall/ -- EpiCept Corporation today announced successful validation of the Marketing Authorization Application (MAA) for Ceplene(TM) (histamine dihydrochloride) by the European Medicines Agency for the Evaluation of Medicinal Products (EMEA). Ceplene is EpiCept’s lead oncology product candidate that administered in conjunction with low dose interleukin-2 (IL-2) will be indicated for use in the maintenance of first remission in patients with Acute Myeloid Leukemia (AML). This positive outcome of validation signifies that the EU centralized evaluation procedure for this MAA will start at the published date of October 25, 2006. Validation of the application means that the EMEA has reviewed the application for completeness, selected the reviewers for the application and set a timetable for the review of the product candidate.
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“We are pleased to have executed on another important milestone for this product candidate and for our company overall,” remarked Jack Talley, President and Chief Executive Officer. “With the validation of our MAA achieved, we anticipate that we will be able to obtain further insights into the approvability of the compound during the first half of 2007.”
The MAA submission for Ceplene will be reviewed under the EU centralized procedure, and if approved, would provide a marketing authorization valid in all EU member states, together with Iceland, Liechtenstein and Norway. The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML.
About Acute Myeloid Leukemia (AML)
AML is the most common form of acute leukemia in adults. There are approximately 47,000 AML patients in the EU, with 14,000 new cases occurring each year. Prospects for long-term survival are poor for the majority of AML patients. Once diagnosed with AML, patients are typically treated with chemotherapy. Although approximately 75 percent of patients achieve a complete remission after such treatment, the leukemia frequently recurs (“relapse”), usually within 1-2 years. Because of the high rate of relapse among patients with AML, only approximately 20% will survive long-term. There are currently no approved remission maintenance therapies for AML patients.
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 oxygen radical formation and release of phagocytes by inhibiting NADPH oxidase, thus protecting IL-2-activated NK-cells and T-cells from oxygen radical-induced inhibition and apoptosis.
About EpiCept Corporation
EpiCept is an emerging specialty pharmaceutical company focused on unmet needs in the treatment of pain and cancer. The Company has a staged portfolio of product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, 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 New Jersey, and the Company’s 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 contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the regulatory status of Ceplene, the efficacy, safety, and intended utilization of the Company’s other product candidates, the conduct and results of future clinical trials, the sufficiency of the Company’s existing capital resources, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that Ceplene will not receive regulatory approval or marketing authorization in the EU, the risk that 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 the Company will not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in the Company’s periodic reports and other filings with the SEC.
EPCT-GEN
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CONTACT: Robert W. Cook of EpiCept Corporation, +1-201-894-8980,rcook@epicept.com; or Francesca T. DeVellis of Feinstein Kean Healthcare,+1-617-577-8110, francesca.devellis@fkhealth.com
Web site: http://www.epicept.com/
