EpiCept Reports New Analysis Supports Ceplene's Favorable Impact on Overall Survival
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Dec 10, 2010 - EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced the results of a new analysis supporting Ceplene's (histamine dihydrochloride) favorable impact on overall survival and its activity with interleukin-2 (IL-2). Ceplene® is approved in the European Union for the maintenance of first remission in patients with Acute Myeloid Leukemia (AML) in conjunction with low dose IL-2.
EpiCept announced in October 2010 that it reached agreement with the U.S. Food and Drug Administration (FDA) for a two-arm, randomized, open-label trial that will compare the efficacy of Ceplene® plus low-dose IL-2 to standard practice in this indication. Based on FDA guidance, the primary endpoint of the trial will be overall patient survival.
In designing this new trial, EpiCept will be guided by the results of the previous Phase III trial for Ceplene® and more particularly by the results of a new subset analysis of 190 patients that were treated aggressively with consolidation therapy before being randomized into the trial. Within this subset of patients, a difference in overall patient survival was seen in favor of Ceplene®/IL-2 versus standard of care (p-value = 0.07, with a median overall benefit of 36 months). This outcome suggests that statistically significant improved overall survival could be achieved in an adequately powered clinical trial.
As previously announced on December 5, 2010, a poster for Ceplene® was presented at the 52nd Annual Meeting of the American Society of Hematology (ASH), which revealed the findings from a Bayesian meta-analysis comparing Ceplene + IL-2 versus IL-2 alone in leukemia free survival in AML patients in remission.
The study found that leukemia free survival from IL-2 monotherapy is similar to that of current standard of care, while the benefit of Ceplene® +IL-2 over standard of care and IL-2 monotherapy is statistically significant. Researchers stated the conclusion reached was robust with respect to the modeling assumptions. This study helped reinforce the consensus that a further clinical trial that utilizes IL-2 monotherapy is not ethical or feasible. The poster “Incremental Benefit of Histamine Dihydrochloride When Added to Interleukin-2 for Remission Maintenance in Acute Myeloid Leukemia: A Bayesian Meta-analysis” was authored by Scott M. Berry, PhD and Kristine R. Broglio, MS, Berry Consultants, LLC, College Station, TX; Donald A. Berry, PhD, Berry Consultants, LLC and Division of Quantitative Sciences, The University of Texas M.D. Anderson Cancer Center, Houston, TX.
“We were very pleased by the positive response we received at ASH from numerous key opinion leaders in hematology in the U.S., both on the results of the meta-analysis as well as on the potential of Ceplene® to profoundly impact the standard of care for AML if approved,” said Jack Talley, President and CEO of EpiCept. “We are encouraged by the results of the new analysis we generated from the earlier Phase III Ceplene® trial and believe that we have a clear and achievable regulatory path for Ceplene®. A successful outcome from the planned U.S. survival trial for Ceplene® would, in our view, establish Ceplene® as a cornerstone of remission maintenance therapy in the U.S.”
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®, which has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. The Company has two 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 EpiCept™ NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
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 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 future financing will not successfully close or that the proceeds thereof will be materially less than anticipated, the risks associated with the adequacy of our existing cash resources 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, 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 EpiCept™ NP-1 or crolibulinTM will not be successful, the risk that EpiCept™ NP-1 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 EpiCept™ NP-1 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; the risk that our securities may be delisted from Nasdaq; 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.
*Azixa is a registered trademark of Myrexis, Inc.
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Contact: EpiCept Corporation
Robert W. Cook, 914-606-3500
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
Bruce Voss, 310-691-7100
Posted: December 2010