TARRYTOWN, N.Y., April 20 /PRNewswire-FirstCall/ -- EpiCept Corporation reported today that studies characterizing a dual mode of action for Azixa(TM), a compound licensed by the Company to Myriad Genetics, Inc. for the treatment of primary and secondary brain tumors, were presented at the annual meeting of the American Association of Cancer Research (AACR) in Los Angeles, California.
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The findings presented by Myriad indicate the potential of Azixa to act as a vascular disrupting agent (VDA), in addition to its previously demonstrated apoptosis inducing capabilities. Vascular disruption of a tumor’s endothelium, the inner layer of cells lining a blood vessel, leads to a loss of blood supply to the tumor and subsequent tumor cell death.
Myriad reported that Azixa induced cell death in several primary types of a tumor’s endothelium, including micro-vessel endothelial cells. Myriad also reported that in human ovarian cancer xenografts, a single dose of Azixa induced dramatic tumor blood vessel damage and tumor cell death within 24 hours.
“Myriad’s findings are another indication of the substantial clinical opportunity that Azixa represents,” remarked Jack Talley, President and Chief Executive Officer. “Our agreement with Myriad provides for significant financial benefits for EpiCept, both in the form of milestone payments and sublicensing income as well as future royalties in the event Myriad’s development of Azixa continues to progress successfully. In addition, the progress made by Myriad with Azixa also provides further validation of the potential of our earlier-stage oncology programs. Notably, we are continuing with our Phase I trial of EPC2407, a novel, small molecule vascular disruption agent and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas, which was discovered through the same Anti-cancer Screening Apoptosis Program (ASAP) responsible for Azixa. EPC2407 is currently dosing its third cohort of patients in an ongoing Phase I study.”
Azixa is part of EpiCept’s MX90745 series of apoptosis inducers, which was licensed to Myriad as part of an exclusive, worldwide development and commercialization agreement. Under the terms of the agreement, Myriad is responsible for all clinical development and commercialization of compounds from this series. Myriad is currently conducting two Phase II clinical trials for Azixa, one in patients with primary brain cancer and the other in melanoma that has spread to the brain.
About EpiCept’s ASAP Technology
Cancerous 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 has been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
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: 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 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 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; competition; litigation; risks associated with our ability to maintain our listing on The Nasdaq Capital Market; 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.
EPCT-GEN
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CONTACT: Robert W. Cook, of EpiCept Corporation, +1-914-606-3572,rcook@epicept.com; Media: Francesca T. DeVellis, of Feinstein KeanHealthcare for EpiCept, +1-617-577-8110, francesca.devellis@fkhealth.com;Investors: Kim Sutton Golodetz, +1-212-838-3777, kgolodetz@lhai.com, orBruce Voss, +1-310-691-7100, bvoss@lhai.com, both of Lippert/Heilshorn &Associates for EpiCept
Web site: http://www.epicept.com/
