TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) announced today the publication of a new meta-analysis which concluded that interleukin-2 (IL-2) monotherapy is not effective as a maintenance therapy for acute myeloid leukemia (AML) patients in first complete remission. These results were published in the July 7, 2011 edition of Blood, a leading scientific journal in hematology.
The analysis appears in an article entitled “Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia,” and was designed to determine the efficacy of IL-2 monotherapy by combining all available individual patient data from five randomized clinical trials and summary data from a sixth trial. The combined individual patient data of 1,455 patients collected over several years showed no benefit of IL-2 compared with standard of care in terms of leukemia free survival (LFS) (p=0.74) or overall survival (OS) (p=0.39). This analysis encompasses all randomized studies examining the role of IL-2 as monotherapy in AML.
The authors highlight the view that the efficacy of IL-2 monotherapy could be hampered by the activity of other immune cells. Several preclinical studies have established a role for Ceplene® (histamine dihydrochloride) to protect the viability and function of anti-leukemic lymphocytes. A Phase III randomized trial of AML patients in complete remission with Ceplene®/IL-2 combination therapy resulted in a significant prolongation of LFS (p<0.01) and a trend towards improvement in OS (p=0.12). The authors conclude that the suggestion that IL-2 has the potential to improve LFS and OS in AML may be valid, but for IL-2 to exert a significant clinical effect on relapse prevention in this disease, its activity may need to be protected by Ceplene®.
The findings of this meta-analysis provide further evidence of the pivotal role that Ceplene® plays in prolonging LFS in AML patients in first remission when used in conjunction with low-dose IL-2.
Jack Talley, EpiCept President and CEO, commented, “The conclusion of this meta-analysis validates our approach that Ceplene® in combination with IL-2 is effective in remission maintenance therapy. Our clinical trial is the only remission maintenance trial to show a clear benefit in prolonging LFS in AML patients. Further, this new analysis also supports our position, endorsed by the European Medicines Agency, that because IL-2 monotherapy treatment has been shown to be ineffective, it is now unethical to offer that therapy in any subsequent clinical study.”
EpiCept is seeking a follow-up meeting with the U.S. Food and Drug Administration (FDA) to discuss the FDA’s responses to the Company’s application for a Special Protocol Assessment for Ceplene® including the FDA’s initial comments on the protocol in favor of an IL-2 monotherapy arm.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company’s lead product is Ceplene®, approved in the EU and Israel for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. The Company has two other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes AmiKet™, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain 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 our 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 risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that our securities may be delisted from The Nasdaq Capital Market, the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene® will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene® will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene®, 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 Myrexis, the risk that the development of our other apoptosis product candidates will not be successful, the risk that clinical trials for AmiKet™ or crolibulinTM will not be successful, the risk that AmiKet™ or crolibulinTM will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet™ on attractive terms, a timely basis or at all, 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; 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 our periodic reports, including our 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 our 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 Myrexis, Inc.