Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) released new data that confirm that leukemia-free survival (LFS) is a valid surrogate endpoint for overall survival (OS) in Acute Myeloid Leukemia (AML) patients in complete remission. These findings are based on an analysis of data from the Phase III trial of Ceplene, EpiCept’s product candidate for the remission maintenance and prevention of relapse in patients with AML in first remission. This data is being presented at the European Hematology Association’s (EHA) 13th Congress in Copenhagen, Denmark.
“We believe the strong association between LFS and OS demonstrated in this study as well as the correlation between the treatment effect of Ceplene in combination with low-dose IL-2 on both LFS and OS provide further compelling evidence of the clinical benefits of Ceplene for AML patients,” remarked Jack Talley, president and CEO of EpiCept. “We have provided this data to regulators in Europe as part of our re-examination proceedings for the Ceplene Marketing authorization Application and believe it provides additional support for our request for a marketing authorization for this important product.”
The poster presentation entitled “Leukemia-free Survival (LFS) as a Surrogate for Overall Survival (OS) in AML Patients in Remission: A Trial of a Novel Immunotherapy with Histamine Dihydrochloride Plus Low-dose IL-2 (HDC/IL2),” will be presented by Dr. Marc Buyse Ph.D., a leading European cancer statistician. The data were derived from the pivotal 320 patient, Phase III trial for Ceplene, which met its primary endpoint of increased LFS (p <0.01) among AML patients in their first remission.
While the extension of OS duration is a principal goal of all cancer therapies, LFS is likely to be a better endpoint by which to evaluate the effect of remission maintenance therapies for AML, as OS may be confounded by alternative salvage therapies and unrelated events. By performing a weighted linear regression analysis between estimates of LFS and OS at specific time points and between the estimated effects of Ceplene with IL-2 on LFS and OS, researchers found a high correlation between the country-specific Kaplan-Meier estimates of 24-month LFS and 36-month OS in both treated and untreated groups (R2 = 0.71; P=0.0002). Similar correlations were also found between 24-month LFS and 48-month and 60-month OS. In addition, country-specific hazard ratios demonstrated that the treatment effect of Ceplene with IL-2 on LFS and OS were found to be highly correlated (R2 = 0.84; P=0.004). These new data add to the evidence of the statistical robustness of the clinical data supporting the benefits of Ceplene in AML.
Additional Ceplene Study Results Presented
In a separate poster presentation given at EHA, EpiCept released new findings from the pivotal Phase III study of Ceplene demonstrating that AML patients maintained their quality of life while undergoing treatment with Ceplene in combination with low-dose IL-2. These data were presented by Dr. Mats Brune, M.D., a leading European hematologist and principal investigator for the Ceplene Phase III clinical trial in a presentation entitled “Quality of Life During Remission Maintenance Immunotherapy in Acute Myeloid Leukemia: A Prospective Assessment using EORTC QLQ-C30 in a Randomized Trial of Histamine Dihydrochloride Plus Low-dose Interleukin-2.”
In the study, researchers compared quality of life and the impact of treatment-related symptoms in AML patients in their first complete remission who received up to 18 months of post-consolidation immunotherapy with Ceplene in combination with low-dose IL-2. Findings were based on the more than 60% of AML patients in the trial who were in first remission, and who had completed the baseline assessment and at least one follow-up quality of life questionnaire. Researchers found that twice daily subcutaneous injections of Ceplene and IL-2 for up to 10 cycles throughout 18-months had no major impact on quality of life and that global health status was maintained from baseline to last evaluation both for patients treated with Ceplene and IL-2 and for untreated control patients. These findings support the safety profile of Ceplene as well as the suitability of the therapy for at home administration in patients in remission from AML.
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.
In March 2008, the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMEA, issued a negative opinion regarding the Marketing Authorization for Ceplene. EpiCept has formally requested a re-examination of this opinion through the appeal process, which is expected to occur in the third quarter of 2008.
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 are typically treated with induction chemotherapy and consolidation therapy, with the majority achieving complete remission. However, about 75-80% of patients who achieve first remission will relapse, and the median time in remission before relapse is only 12 months with current treatments. Less than 5% 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 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 recently received a negative opinion and is being re-examined 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: our appeal of the negative opinion regarding the MAA for Ceplene® will not be successful and that Ceplene® will not receive regulatory approval or marketing authorization in the EU, the risk that Ceplene®, if approved, will not achieve significant commercial success, the risks associated with the adequacy of our existing cash resources and 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 or that our secured lender would seek to sell our assets, the risk that the Company's securities may be delisted by The Nasdaq Capital Market and that any appeal of the delisting determination may not be successful, 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 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 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 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.
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