TARRYTOWN, N.Y., Dec. 4 /PRNewswire-FirstCall/ -- EpiCept Corporation today announced that it will be presenting new clinical data for Ceplene (histamine dihydrochloride) at the upcoming 49th Annual Meeting of the American Society of Hematology (ASH), taking place in Atlanta, Georgia from December 8-11, 2007. Ceplene is EpiCept’s lead oncology product candidate under late stage review by the European Medicines Evaluation Agency (EMEA) for the remission maintenance treatment and prevention of relapse of patients with Acute Myeloid Leukemia (AML) in first remission.
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The results to be presented at the meeting include an analysis of the long-term outcomes of AML patients enrolled in the pivotal Phase III Ceplene study. The new data compares the effects of post-consolidation immunotherapy with histamine dihydrochloride (HDC) in conjunction with low dose interleukin- 2 (IL-2) on leukemia-free survival and overall survival compared to the current standard of care, which is no treatment, at five years post initiation of therapy.
The following poster presentations will be given by EpiCept on Sunday, December 9, 2007 from 9:00 a.m. to 8:00 p.m. Eastern Time at Hall B3 and B4 in the Georgia World Congress Center.
A third abstract developed by EpiCept investigators entitled “Impact on Quality of Life of Postconsolidation Immunotherapy with Histamine Dihydrochloride and Interleukin-2 in Acute Myelogenous Leukemia” appeared in the November edition of Blood, The Journal of The American Society of Hematology. This paper demonstrated that patients treated with Ceplene in conjunction with low dose interleukin-2 had an equivalent quality of life compared to the current standard of care, which is no treatment, in the pivotal trial.
EpiCept also announced today that it is providing an educational grant in support of a CME-certified Symposium for clinicians and scientists specializing in hematology and oncology entitled “Improving Outcomes in Acute Myeloid Leukemia.” The event will take place on Friday, December 7, 2007 beginning at 7:00 p.m. in Room B211-212, Building B, Level 2 at the Georgia World Congress Center in Atlanta, Georgia. Additional information on the Symposium is available at www.dwrite.com/ASH2007.
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 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 our NP-1 clinical trials will not be successful, that NP-1 will not receive regulatory approval or achieve significant commercial success, the risk that Myriad’s development of Azixa(TM) 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 EPC 2407 will not be successful, that 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 our need to raise additional financing to continue to meet our capital needs and our ability to continue as a going concern, 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,
rcook@epicept.com; Media, Greg Kelley of Feinstein Kean Healthcare, +1-617-
577-8110, gregory.kelley@fkhealth.com; Investors, Kim Sutton Golodetz,
+1-212- 838-3777, kgolodetz@lhai.com or Bruce Voss, +1-310-691-7100,
bvoss@lhai.com, both of Lippert-Heilshorn & Associates
Web site: http://www.epicept.com/
http://www.dwrite.com/ASH2007/
