TARRYTOWN, N.Y., Aug. 17 /PRNewswire-FirstCall/ -- EpiCept Corporation today reported on new clinical advancements for Azixa(TM)* (MPC-6827), a vascular disrupting agent licensed by the Company to Myriad Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement.
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Myriad announced yesterday that it has initiated a third Phase II clinical trial for Azixa in patients with non-small-cell lung cancer that has spread to the brain. The trial is designed to assess Azixa's safety profile and the extent to which it can improve the overall survival of these patients. Two additional Phase II trials for Azixa are underway in primary brain cancer and melanoma that has spread to the brain.
"We are pleased at the clinical advancement Myriad has reported on Azixa, and view it as further evidence of the commercial potential of the compound," stated Jack Talley, President and Chief Executive Officer. "We believe that the study of Azixa in this new indication affords EpiCept with an expanded opportunity to capitalize on the financial benefits associated with our agreement with Myriad, including milestone payments, sublicensing income and potentially future royalties if Azixa continues to progress successfully."
Myriad is responsible for the worldwide development and commercialization of Azixa and any drug candidate that is developed from the series of compounds licensed by EpiCept to Myriad in 2003. The agreement requires that Myriad make future licensing, research and milestone payments to EpiCept, as well as pay a portion of any sublicensing income and pay a royalty on product sales. EpiCept will earn a milestone payment upon the dosing of the first patient in a Phase II trial and another milestone upon the dosing of the first patient in a Phase III trial for any use of the drug.
Myriad also reported data from two completed Phase 1 clinical trials of Azixa in a total of 66 patients, one in patients with refractory solid tumors that may also have had brain metastases and the other in patients with known brain metastases. The trials were designed to explore the safety and pharmacokinetics of Azixa and to find the maximum tolerated dose of the compound. Myriad reported that in the Phase 1 studies, Azixa appeared to have a biological effect on patients' metastases from many different primary tumors, including non-small-cell lung cancer, which is consistent with the mechanism of the drug candidate.
Azixa is one of two compounds in clinical trials discovered through EpiCept's Anti-cancer Screening Apoptosis Program (ASAP). EPC2407, a novel small molecule vascular disruption agent and apoptosis inducer for the treatment of cancer patients with advanced, solid tumors and lymphomas, is currently in Phase I clinical development by EpiCept. In July 2007, EpiCept announced the acceleration of the Phase I clinical trial, with results expected later this year. EpiCept expects to initiate a second Phase I efficacy trial for EPC2407 as a combination therapy in patients with well vascularized solid tumors and intends to choose multiple tumor targets for the compound's Phase II trials as the clinical profile from the ongoing monotherapy trial emerges.
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 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.
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 Ceplene will not receive regulatory approval or marketing authorization in the EU or that Ceplene, if approved, will not achieve significant commercial success, 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 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 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.