TARRYTOWN, N.Y., July 3 /PRNewswire-FirstCall/ -- EpiCept Corporation today announced that with the initiation of a new study center, Tower Cancer Research Foundation in Los Angeles, it will accelerate the recruitment of patients in the currently ongoing Phase I clinical study of EPC2407, a novel small molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas. The first two cohorts of patients have been completed according to schedule at Scottsdale Healthcare Center. The third cohort is currently ongoing at Scottsdale Healthcare Center and at the University of California, Moores Cancer Center, San Diego.
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EPC2407 belongs to a novel class of microtubulin inhibitors discovered by EpiCept. These compounds cause caspase activation, cell cycle arrest, and apoptotic death in cancer cells.
The Phase I trial of EPC2407 is now being conducted in three U.S. cancer centers and will administer increasing doses to small groups in approximately 30-40 patients with advanced stages of solid tumors. The primary objectives of the study are to determine the safety (maximum tolerated dose) and the pharmacokinetic profile of the drug. The study will also characterize the pharmacodynamic effects on tumor blood flow and identify early signs of objective anti-tumor response as measured by CT scans, MRI or PET, in these advanced cancer patients with well vascularized solid tumors.
Dr. Peter J. Rosen, Medical Director at Tower Cancer Research Foundation, stated, “Tower Oncology is very excited to work with EpiCept on the clinical development of EPC2407, a product with a new mechanistic approach, which could offer significant advantages in the fight against cancer.”
EpiCept President and Chief Executive Officer Jack Talley commented, “We are pleased to be joined by Tower Cancer Research Foundation in the development of EPC2407 and we believe that their participation will result in our completing the trial ahead of plan. We expect to be in a position to report the results of this important clinical trial later this year.”
EPC2407 has shown promising vascular targeting activity with nanomolar potencies of anti-tumor activity in pre-clinical in vitro and in vivo studies. The molecule has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts demonstrated EPC2407 inhibits growth of established tumors of a number of different cancer types more effectively than the other VDAs tested and was synergistic when used in combination with anticancer agents, such as Cisplatin. The combination of EPC2407 with other anticancer agents in a Phase 1b trial is planned to follow the current monotherapy trial. EPC2407 is one of two VDA compounds currently in clinical trials discovered through EpiCept’s Anti-cancer Screening Apoptosis Program (ASAP). The second compound, Azixa(TM), 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 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.
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 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 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 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 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 http://www.sec.gov or at http://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.
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CONTACT: Robert W. Cook of EpiCept Corporation, +1-914-606-3500,rcook@epicept.com; or Media: Greg Kelley of Feinstein Kean Healthcare,+1-617-577-8110, gregory.kelley@fkhealth.com; or Investors: Kim SuttonGolodetz, +1-212-838-3777, kgolodetz@lhai.com, or Bruce Voss,+1-310-691-7100, bvoss@lhai.com, both of Lippert-Heilshorn & Associates
Web site: http://www.epicept.com//
