EpiCept Reports New Data on Benefits of Maintenance Therapy With Ceplene and interleukin-2 For AML Patients At ASH Annual Meeting
Phase III data demonstrates significantly improved leukemia-free survival (LFS) for patients in complete remission
Improved LFS correlates with improved overall survival
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Dec 4, 2008 - Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that new data on the benefits of maintenance therapy with Ceplene® (histamine dihydrochloride) and interleukin-2 (IL-2) for Acute Myeloid Leukemia (AML) patients in complete remission will be presented at the 50th American Society of Hematology (ASH) Annual Meeting being held December 6-9 at the Moscone Center in San Francisco. Analyses of the pivotal Phase III trial data confirm the consistency and robustness of the Ceplene®/IL-2 effect over control or no treatment to prolong LFS and prevent relapse in AML patients in their first complete remission (CR1). Ceplene® is the first medical therapy to achieve this outcome. Moreover, the improvement in LFS correlated closely with an improved overall survival.
“Delaying and preventing relapse in AML patients who achieve complete remission is critical to their long-term survival,” said Jack Talley, President and CEO of EpiCept. “Ceplene®/IL-2 is the first approved therapy for remission maintenance demonstrating the benefits of prolonged leukemia-free survival in AML patients in first remission.” The presentation, “Post-Consolidation Immunotherapy with Histamine Dihydrochloride and Interleukin-2 in AML: Assessment of Consistency and Robustness of Treatment Benefit for Patients in First Complete Remission,” will occur on Sunday, December 7, 2008, between 6:00 and 8:00 p.m. Pacific time (Hall 1, Moscone center).
Ceplene® recently received marketing approval in Europe for maintenance therapy and prevention of relapse in adult patients with AML in first remission. EpiCept is currently in the process of selecting a European commercial partner for this innovative new therapy. The Company also intends to pursue regulatory approvals for Ceplene® in the U.S. and Canada.
Ceplene® is EpiCept's proprietary product approved in Europe for maintenance therapy for adult patients with AML in first remission. 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 Acute Myeloid Leukemia (AML)
AML is the most common type of leukemia in adults. There are approximately 40,000 AML patients in the EU, with 16,000 new cases occurring each year. Once diagnosed with AML, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, about 70-80% of patients who achieve first remission will relapse, with the median time in remission before relapse being only 12 months. Less than 15% of relapsed patients survive long-term.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of cancer and pain. The Company's broad portfolio of pharmaceutical product candidates includes Ceplene®, a cytokine immunomodulator that recently received marketing authorization in Europe for the remission maintenance of AML patients, and several pain therapies in clinical development. 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.
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 be launched in Europe in the first quarter of 2009 or achieve significant commercial success, the risk that we are unable to find a suitable marketing partner for Ceplene® on attractive terms, a timely basis or at all, the risk that any required post-approval clinical study will not be successful, the risk that EpiCept will not be able to maintain its final regulatory approval or marketing authorization, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the US or Canada, the risks associated with the adequacy of our existing cash resources, 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 our ability to continue to meet our obligations under our existing debt agreements or that we may default on our loans or that our lenders may declare the Company in default, the risk that the Company's securities may be delisted by The Nasdaq Capital Market or the OMX Nordic Exchange, 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, including our current clinical trial in PHN, or EPC2407 will not be successful, the risk that NP-1 or EPC2407 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 risks associated with our 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; the highly competitive nature of our business; risks associated with litigation; 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. 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.
*Azixa is a registered trademark of Myriad Genetics, Inc.
Posted: December 2008