TARRYTOWN, N.Y., June 15, 2007 /PRNewswire-FirstCall/ -- EpiCept Corporation today announced the results of scientific studies that (1) demonstrate that Azixa(TM) (MPC-6827) is effective in treating multiple types of human tumors in animal models, (2) reveal a mechanism by which MPC-6827 exerts its effects, and (3) show that MPC-6827 is not affected by cellular proteins known to be involved in cancer drug resistance. The study results appear in the June 15, 2007 edition of Cancer Research, a journal published by the American Association of Cancer Research (AACR).
"The results of this study demonstrate the potential of Azixa (MPC-6827) to offer significant anti-tumor activity, even in tumors expressing multi-drug resistant phenotypes," remarked Jack Talley, President and Chief Executive Officer. "These data further exemplify the potential of our proprietary Anti- cancer Screening Apoptosis Program, through which this compound was discovered."
The Cancer Research authors describe results showing that MPC-6827 displays significant activity in inhibiting the growth of a broad spectrum of solid tumor lines in athymic nude mice, including human breast, colon, pancreas, ovarian and mouse melanoma. Additional in vitro studies demonstrated that MPC-6827 exerts its effects by binding of tubulin, thereby inhibiting polymerization and leading to cell cycle arrest and apoptosis. Unlike other tubulin-disrupting cancer treatments, MPC-6827 had efficacy against tumor cells that over-expressed the three main protein transporters responsible for multidrug resistance, indicating that MPC-6827 may prove effective against drug resistant tumors in a clinical setting.
MPC-6827 is one of two compounds currently in clinical trials discovered through EpiCept's Anti-cancer Screening Apoptosis Program (ASAP). MPC-6827 is part of the EP90745 series of apoptosis inducers, which was licensed by EpiCept to Myriad Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement. Myriad recently announced that MPC-6827, which is being developed under the trademark Azixa(TM), has a second mode of action due to vascular disruption activity (VDA). The compound is currently being evaluated in two Phase II human clinical trials, one in patients with primary brain cancer and the other in brain metastases due to melanoma. EpiCept's licensing agreement with Myriad for Azixa includes milestone payments, and sublicensing income as well as future royalties in the event Myriad's development of Azixa continues to progress successfully.
The Cancer Research article, entitled "MPC-6827: A Small Molecule Inhibitor of Microtubule Formation that is Not a Substrate for Multi-Drug Resistance Pumps," was co-authored by researchers at EpiCept Corporation, Myriad Pharmaceuticals, Inc. and the Department of Therapeutic Radiology and Oncology and Department of Internal Medicine, Innsbruck Medical University, Austria.
About EpiCept's ASAP Technology
Cancer cells often exhibit unchecked growth caused by the disabling or absence of the natural process of programmed cell death, which is called apoptosis. Apoptosis is normally triggered to destroy a cell from within when it outlives its purpose or it is seriously damaged. One of the most promising approaches in the fight against cancer is to selectively induce apoptosis in cancer cells, thereby checking, and perhaps reversing, the improper cell growth.
EpiCept's proprietary apoptosis screening technology can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells through the use of chemical genetics and its proprietary live cell high-throughput caspase-3 screening technology. Chemical genetics is a research approach investigating the effect of small molecule drug candidates on the cellular activity of a protein, enabling researchers to determine the protein's function. Using this approach with its proprietary caspase-3 screening technology, EpiCept researchers can focus their investigation on the cellular activity of small molecule drug candidates and their relationship to apoptosis.
This combination of chemical genetics and caspase-3 screening technology allows EpiCept's researchers to discover and rapidly test the effect of small molecules on pathways and molecular targets crucial to apoptosis, and gain insights into their potential as new anticancer agents. This screening technology is particularly versatile and can be adapted for almost any cell type that can be cultured, as well as measure caspase activation inside multiple cell types (e.g., cancer cells, immune cells, or cell lines from different organ systems or genetically engineered cells). This allows researchers to find potential drug candidates that are selective for specific cancer types, which may help identify candidates that provide increased therapeutic benefit and reduced toxicity.
EpiCept has identified several families of compounds with potentially novel mechanisms that induce apoptosis in cancer cells. Several compounds from within these families have progressed to lead drug candidate status with proven pre-clinical efficacies in tumor models and identified molecular targets.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer. EpiCept has a staged portfolio of pharmaceutical product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound is under review by the European Agency for the Evaluation of Medicinal Products (EMEA). EpiCept is based in Tarrytown, N.Y., and its research and development team in San Diego is pursuing a drug discovery pr ogram focused on novel approaches to apoptosis.
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: 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 will not be successful, that NP-1 will not receive regulatory approval or achieve significant commercial success, the risk that Ceplene will not receive regulatory approval or marketing authorization in the EU, 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 EpiCept will not obtain approval to market any of its product candidates, the risks associated with reliance on additional outside financing to meet its capital requirements, the risks associated with dependence upon key p ersonnel, 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; competition; litigation; risks associated with our ability to have our common stock readmitted to trading on The Nasdaq Global Market; risks associated with prior material weaknesses in our internal controls; 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.
*Azixa is a registered trademark of Myriad Genetics, Inc.
CONTACT: media, Robert W. Cook of EpiCept Corporation, +1-914-606-3500, or, or Greg Kelley of Feinstein Kean Healthcare,+1-617-577-8110, or , for EpiCept Corporation,or investors, Kim Sutton Golodetz, +1-212-838-3777, or ,or Bruce Voss, +1-310-691-7100, or , both ofLippert/Heilshorn & Associates, for EpiCept Corporation firstname.lastname@example.org email@example.com firstname.lastname@example.org email@example.com
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