15.12.2009 05:01:00

EpiCept Provides Clinical and Business Update on Ceplene Program

Regulatory News:

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today provided an update on new clinical developments and other initiatives related to Ceplene® (histamine dihydrochloride), the Company’s therapy approved in the European Union for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.

EpiCept announced plans to initiate two new studies for Ceplene and provided an update on another study for Ceplene intended to help achieve an expanded indication and broaden use for the drug. These studies include:

  • A Phase I/II study that will research the effects of a regimen of Ceplene and low-dose interleukin-2 (IL-2) in combination with Gleevec® (imatinib mesylate) on the eradication of minimal residual disease (MRD) in adult patients with chronic myeloid leukemia. The study will be led by the Nordic Chronic Myeloid Leukemia Study Group (NCMLSG), which is comprised of physicians and researchers in Sweden, Denmark, Norway and Finland. The primary objective of the study will be to assess the safety of the combination therapy of Ceplene/IL-2 with Gleevec given for six months and to assess the number of patients achieving and subsequently maintaining disease-free survival after discontinuation of Gleevec. Patients will be followed for a minimum of 18 months after discontinuation of Gleevec therapy. MRD will be followed using a specific market resulting from a chromosomal abnormality found in CML.
  • The initiation of a study led by GFM (Groupe Francophone des Myélodysplasies) that will examine the effects of Ceplene/IL-2 in combination with Vidaza® (azacitidine) in the treatment of patients with higher risk myelodsyplastic syndromes (MDS), a bone marrow disease that can progress to AML. These patients will already have demonstrated a hematological response to Vidaza. This trial will be followed by a randomized Phase II study of the efficacy, safety and tolerability of the addition of Ceplene/IL-2 to Vidaza compared to Vidaza alone in patients with higher risk MDS and who have achieved hematological response to Vidaza.
  • The post-approval clinical study of Ceplene initiated in July 2009 that is studying the effects of remission maintenance therapy with Ceplene/IL-2 on MRD in adult patients with AML in first complete remission. This open-label, multicenter study will also assess the quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on these patients by monitoring T and natural killer cell phenotypes and their functionality after the first and third treatment cycles. Enrollment in this study is ongoing and the study will enroll up to 150 patients at approximately 25 centers across Europe with sites in Sweden, Belgium, France, the U.K., Spain and Italy.

EpiCept also announced today that the first meeting of the Scientific Advisory Board (SAB) it established in collaboration with the European LeukemiaNet Foundation took place on November 18, 2009. The SAB, comprised of 10 key opinion leaders in AML and who collectively practice in all of the major countries in the European Union, gathered to formulate strategies to increase physician awareness and education of the benefits of Ceplene in treating AML patients in Europe. As an outcome of that meeting, SAB members have committed to help facilitate physician access to and use of Ceplene in AML and hematologic disease.

EpiCept had a commercial presence at both the European Hematology Association earlier this year and at the American Society of Hematology meeting in December. The company intends to continue and expand upon these efforts in 2010 in conjunction with a European partner, as appropriate, to facilitate the commercial launch of Ceplene.

"We believe that positive results from either the trial of Ceplene in MDS with Vidaza or Ceplene in CML with Gleevec would indicate a potentially significant public health benefit from the use of Ceplene in combination with these currently marketed drugs, and provide an important pathway for expanding the label for Ceplene and its future market potential,” remarked Jack Talley, President and Chief Executive Officer of EpiCept. "These trials, along with the efforts of our SAB, are increasing Ceplene’s exposure to physicians in Europe and educating them on its proper use and administration. We believe these efforts will provide significant rewards for EpiCept in the future as we work towards finalizing a commercial partnership agreement for this life-saving medicine.”

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.

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 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 our securities may be delisted by The Nasdaq Capital Market and that any appeal of the delisting determination may not be successful, the risk that Ceplene will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene will not be launched 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 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 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 we will not be able to find a buyer for our ASAP technology, the risk that clinical trials for EpiCeptTM NP-1 or crinobulin will not be successful, the risk that EpiCept NP-1 or crinobulin 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 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 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

*Gleevec is a registered trademark of Novartis Pharmaceuticals.

*Vidaza is a registered trademark of Celgene Corporation.

*Azixa is a registered trademark of Myriad Genetics, Inc.

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