ENGLEWOOD CLIFFS, N.J., March 31 /PRNewswire-FirstCall/ -- EpiCept Corporation announced today that the results from a randomized, multi-center Phase III clinical study of 320 patients with Advanced Myeloid Leukemia (AML) in which Ceplene(TM), the company’s lead oncology compound for the treatment of AML, met its primary endpoint of increased leukemia-free survival among AML patients in remission, were published online in Blood, a leading scientific journal in hematology on March, 24, 2006. The Blood article is entitled “Improved Leukemia-Free Survival After Post-Consolidation Immunotherapy with Histamine Dihydrochloride and Interleukin-2 in Acute Myeloid Leukemia: Results of a Randomized Phase III Trial” and authored by Mats Brune and co-workers.
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Based on the findings of this study, EpiCept plans to file a Market Authorization Application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) for approval of Ceplene in Europe in 2006 as remission maintenance therapy for patients with AML.
Background
AML patients receive intensive treatment with chemotherapeutic drugs at diagnosis, and typically become free of detectable leukemia (“complete remission”). However, the majority of patients will experience relapse of leukemia, usually within 1-2 years. The survival prognosis after a leukemic relapse is poor. Ceplene treatment aims at preventing leukemic relapses in AML patients.
Study Results
The study was conducted in eleven countries. The results showed that patients with AML in complete remission who received 18 months of treatment with Ceplene (histamine dihydrochloride) plus low dose interleukin-2 (IL-2) experienced a significantly improved leukemia-free survival compared to the current standard of care. The predefined primary endpoint of the Phase III trial was leukemia-free survival in the population of all patients randomized (n=320) at >3 years follow-up, and the improvement of leukemia-free survival achieved by Ceplene/IL-2 was statistically significant (p=0.0096, analyzed according to Intent-to-Treat).
“The high rate of relapse of leukemia in AML patients is a major clinical challenge,” said Dr. Mats Brune, M.D., Ph.D. at the Sahlgrenska University Hospital, and Study Chairman of the trial. “It is gratifying that treatment with Ceplene/IL-2 appears to be associated with improved long-term leukemia- free survival.”
“There is an urgent need for new therapeutic options for patients suffering from AML,” said Professor Kristoffer Hellstrand, M.D., Ph.D. at the Sahlgrenska University Hospital, Goteborg, Sweden, an author of the study. “These data indicate that treatment with Ceplene/IL-2 offers an efficacious and tolerable option for AML patients in remission.”
“Ceplene is designed to address significant unmet clinical needs for alternative treatment options for AML patients,” said Jack Talley, CEO of EpiCept. “There are approximately 14,000 new cases of AML in Europe each year, and there are no established relapse-preventive therapies for these patients. Our Phase III results are very encouraging, and will form the basis for the submission of our MAA for Ceplene in Europe planned for later this year.”
Study Details
In the Phase III trial, patients were randomized to receive either 18 months of treatment with Ceplene/IL-2 or no treatment (standard of care). All patients were observed for a total of at least 36 months after enrollment.
Three years after enrollment of the last patient, treatment with Ceplene/IL-2 was found to improve leukemia-free survival over control in the population of all participating patients (n=320, p=0.0096, Log Rank Test, intent-to-treat analysis). The benefit of Ceplene/IL-2 was attributable mainly to a reduction of the frequency of relapse among patients in their first complete remission (n=261). For these patients, treatment with Ceplene/IL-2 significantly improved leukemia-free survival (p=0.01) with 3-year leukemia-free survival estimates of 40% (Ceplene/IL-2) compared to 26% (control).
Side effects were typically mild to moderate. The most common adverse events reported among patients who took Ceplene/IL-2 were injection site reactions, fever and fatigue. The incidence of serious adverse events (SAEs) was equal in treated and untreated patients. No treatment-related mortality was observed.
About Acute Myeloid Leukemia
AML is the most common form of acute leukemia in adults. There are approximately 11,900 new cases of AML and 8,900 deaths caused by this cancer each year in the United States, with similar incidence and mortality rates in Europe. Prospects for long-term survival are poor for the majority of AML patients. Once diagnosed with AML, patients are typically treated with chemotherapy. Although approximately 75% of patients achieve a complete remission after such treatment, the leukemia frequently recurs (“relapse”), usually within 1-2 years. Because of the high rate of relapse among patients with AML, only approximately 20% will survive long-term. There are currently no established remission maintenance therapies for AML patients.
About Ceplene
Ceplene is EpiCept’s registration-stage compound for the treatment of AML. Ceplene is based on the naturally occurring molecule histamine, and is designed to prevent or inhibit oxidative stress, thus protecting critical immune cells. Research has demonstrated that oxidative stress suppresses the immune system’s ability to destroy cancer cells, including malignant AML cells.
About EpiCept Corporation
EpiCept is an emerging pharmaceutical company focused on unmet needs in the treatment of pain and cancer. The company has a staged portfolio with several pain therapies in late-stage clinical trials, and a lead oncology compound (Ceplene for AML) with demonstrated efficacy in a Phase III trial; the compound is intended for commercialization in Europe. EpiCept is based in New Jersey, and the company’s R&D team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
Forward Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the planned EMEA filing application for Ceplene, the efficacy, safety, and intended utilization of the Company’s respective product candidates, the conduct and results of future clinical trials, and plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that EpiCept will not obtain approval to market Ceplene or its other products, the risk that Ceplene or its other products will not be successfully commercialized if approved, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in EpiCept’s periodic reports and other filings with the SEC.
EPCT-GEN
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CONTACT: Robert W. Cook of EpiCept Corporation, +1-201-894-8980,rcook@epicept.com; or Lev Janashvili of Feinstein Kean Healthcare,+1-617-761-6731, lev.janashvili@fkhealth.com
Web site: http://www.epicept.com/
