TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and Nasdaq: EPCT) today announced that at a recent meeting with the U.S. Food and Drug Administration (FDA) the Company was provided more definitive guidance regarding the clinical development of Ceplene® (histamine dihydrochloride), the Company’s lead product administered with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission. Ceplene® is approved and being marketed in the European Union by Meda AB and in Israel by Megapharm, Ltd.
At the meeting, the FDA indicated that as part of a registration study, the effect of Ceplene® must be isolated from the effect of IL-2; therefore the preferred study design will be a comparison of Ceplene®/IL-2 vs. IL-2 monotherapy. Furthermore, the FDA recommended that the patients in the IL-2 monotherapy group receive the same IL-2 dosing regimen as those patients receiving Ceplene®/IL-2 in combination. The FDA reiterated the need to demonstrate a significant benefit of Ceplene®/IL-2 vs. IL-2 monotherapy on overall survival, which needs to be the primary endpoint of the trial. Leukemia-free survival (LFS) can be a secondary endpoint provided that bone marrow samples are collected at pre-specified and regular intervals during the course of the trial.
EpiCept intends to work with key opinion leaders in the preparation of a new trial protocol and will submit the protocol to the FDA in order to receive further guidance and approval for Special Protocol Assessment as soon as possible.
EpiCept President and CEO Jack Talley commented, “We appreciate the input received from the FDA, which outlined a clear path for the registration of Ceplene® in the U.S. We will incorporate the FDA’s feedback in the design of a new pivotal clinical study with appropriate treatment arms and endpoints, such that, assuming a positive trial result, only one new pivotal study will be sufficient to support the submission of a new drug application.”
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 AmiKet™, 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 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 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; 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.