Archive for October, 2006

NGLEWOOD CLIFFS, New Jersey, October 2 /PRNewswire/ – – EPC2407 Latest Clinical Candidate from Company’s Apoptosis ScreeningTechnology EpiCept Corporation (Nasdaq: EPCT; OMX Stockholm) today announced that ithas submitted an investigational new drug (IND) application to the U.S. Foodand Drug Administration (FDA) to begin Phase I clinical studies of EPC2407 incancer patients. EPC2407 is the Company’s novel small molecule which inducesapoptosis (cell death) and disruption of tumor blood flow. EPC2407 isintended for the treatment of advanced cancer patients with solid tumors thatare well vascularized. These tumors include the frequently occurring cancersof the lung, ovaries, and breast. These cancers still have a high mortalityrate despite progress in earlier stages of these diseases. (Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO ) EPC2407 is the first of a new class of microtubulin inhibitors whichcause cell cycle arrest, caspase activation and apoptotic death in cancercells. The compound has demonstrated in pre-clinical studies potentanti-tumor activity against a number of tumor types and is synergistic withcisplatin. EPC2407 also disrupts the vasculature of tumor blood vesselsleading to hypoxia and tumor necrosis. This has been shown to occur inpre-clinical studies in tumored animals at subtoxic concentrations. Theobjectives of this first clinical trial of EPC2407 is to determine themaximum tolerated dose, to characterize the blood levels and biologicaleffects of the drug and to identify any anti-tumor response as measured by CTscans, MRI or PET scans. The study is expected to enroll approximately 30-40patients. One of the investigators for this study is Dr. Daniel von Hoff from theCenter for Translational Drug Development, TGen, the Scottsdale HealthcareClinical Research Institute and the Arizona Cancer Center. Dr. von Hoffcommented, “We are pleased to work with EpiCept Corporation to test thispotential new anti-cancer compound in patients with advanced cancers. Resultsfrom pre-clinical testing of EPC2407 are encouraging, and mechanism studiessuggest two ways that this new agent may add to our treatment options for arange of cancers.”“The filing of an IND for EPC2407 represents an important milestone forour company,” stated Jack Talley, President and Chief Executive Officer. “Webelieve this filing deepens our already promising clinical pipeline of painand cancer treatment candidates and further demonstrates the potential of ourproprietary apoptosis screening technology which led to the discovery anddevelopment of EPC2407. This compound represents the second clinical cancercandidate discovered by EpiCept researchers utilizing this technology. Wehave identified several other promising compounds with the potential forfurther development which we intend to selectively pursue. Our goal is toprogress these product candidates into clinical development and seek partnersprior to the commencement of pivotal scale trials.” About EPC2407 The IND filing for EPC2407 is based on the compound’s effectiveness inseveral pre-clinical animal models of cancer and its potent anti-tumoreffects both in vitro and in vivo. Nanomolar concentrations of the moleculehave been shown to induce tumor cell apoptosis and to selectively inhibitgrowth of proliferating cell lines, including multi-drug resistant celllines. Murine models of human tumor xenografts demonstrated that EPC2407inhibits growth of established tumors of a number of different cancer types.The safety profile of the compound in standard toxicology studies alsosupports its testing in human clinical trials. Pre-clinical studies suggest that the anti-tumor effects of EPC2407 maybe the result of a dual mechanism, a direct effect of tumor apoptosis and asecond effect on disruption of tumor vascular endothelial cells leading tohypoxia and central tumor necrosis, as observed with vascular disruptionagents. About EpiCept’s Apoptosis Screening Technology Cancer cells often exhibit unchecked growth caused by the disabled orabsent natural process of programmed cell death called apoptosis. Apoptosisis a normal process of triggering destruction of cells from within when theyhave outlived their purpose or may be seriously damaged, but cancer cellsgrow out of control when the normal apoptosis process is not functioning. Apromising approach in the fight against cancer is selective induction of orrestoration of apoptosis, thereby checking, and perhaps reversing, theimproper cell growth. EpiCept’s proprietary apoptosis screening technology can efficientlyidentify new cancer drug candidates and molecular targets that selectivelyinduce apoptosis in cancer cells through the use of chemical genetics and itsproprietary live cell high-throughput caspase-3 screening technology.Chemical genetics is a research approach investigating the effect of smallmolecule drug candidates based on the cellular activity of a protein,enabling researchers to determine the protein’s function. With thecombination of chemical genetics and caspase-3 screening, EpiCept’sresearchers identify and test the effect of small molecules on pathways andmolecular targets crucial to apoptosis and gain insights into their potentialas new anticancer agents. The Company’s screening technology is particularlyversatile and can be adapted for many cell types that can be cultured, and itcan measure caspase activation inside multiple cell types (e.g. cancer cells,immune cells, or cell lines from different organ systems or geneticallyengineered cells). This allows researchers to find potential drug candidatesthat are selective for specific cancer types, which may help identifycandidates that provide increased therapeutic benefit and reduced toxicity. EpiCept’s drug discovery and pre-clinical development groups include highthroughput screening (HTS) and informatics, cell biology, medicinalchemistry, and in vivo pharmacology. The HTS group identifies the hits whichupon passing certain criteria are analoged by the chemistry group forsecondary and tertiary assay testing by the cell biology group. Promisingleads are tested in animal models for toxicity, efficacy andpharmacokinetics. An iterative interaction between the various groupsprovides for the rapid advancement from hit compounds to lead candidatessuitable for further development. About EpiCept Corporation EpiCept is an emerging specialty pharmaceutical company focused on unmetneeds in the treatment of pain and cancer. The Company has a staged portfolioof product candidates with several pain therapies in late-stage clinicaltrials, and a lead oncology compound (for acute myeloid leukemia, AML) withdemonstrated efficacy in a Phase III trial; a marketing authorizationapplication for this compound will be submitted in Europe in the near future.EpiCept is based in New Jersey, and the Company’s research and developmentteam in San Diego is pursuing a drug discovery program focused on novelapproaches to apoptosis. Forward-Looking Statements This news release contains certain forward-looking statements thatinvolve risks and uncertainties that could cause actual results to bematerially different from historical results or from any future resultsexpressed or implied by such forward-looking statements. Such forward-lookingstatements include statements regarding the efficacy, safety, and intendedutilization of the Company’s product candidates, the conduct and results offuture clinical trials, the sufficiency of the Company’s existing capitalresources, plans regarding regulatory filings, future research and clinicaltrials and plans regarding partnering activities. Factors that may causeactual results to differ materially include the risk that product candidatesthat appeared promising in early research and clinical trials do notdemonstrate safety and/or efficacy in larger-scale or later stage clinicaltrials, the risk that the Company will not obtain approval to market itsproduct candidates, the risks associated with reliance on outside financingto meet capital requirements, and the risks associated with reliance oncollaborative partners for further clinical trials, development andcommercialization of product candidates. You are urged to consider statementsthat include the words “may,”"will,”"would,”"could,”"should,”"believes,”"estimates,”"projects,”"potential,”"expects,”"plans,”"anticipates,”"intends,”"continues,”"forecast,”"designed,”"goal,” or the negative ofthose words or other comparable words to be uncertain and forward-looking.These factors and others are more fully discussed in the Company’s periodicreports and other filings with the SEC. EPCT-GEN Web site: http://www.epicept.comEpiCept CorporationRobert W. Cook, EpiCept Corporation, +1-201-894-8980, rcook@epicept.com; or Francesca T. DeVellis, Feinstein Kean Healthcare, +1-617-577-8110, francesca.devellis@fkhealth.com /Photo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO