EpiCept Announces Presentation of EPC2407 Data at 2008 American Society of Clinical Oncology Annual Meeting TARRYTOWN, N.Y.--(BUSINESS WIRE)--May 28, 2008--Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it will present data from its Phase I trial of EPC2407 at the 44th Annual Meeting of the American Society for Clinical Oncology (ASCO), taking place May 30 to June 3, 2008 in Chicago. EPC2407 is EpiCept's novel small molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas. Presentation details are as follows: Abstract Title: Initial results of a first-in-man Phase I study of EPC2407, a novel small molecule microtubule inhibitor anticancer agent with tumor vascular endothelial disrupting activity. Authors: S. P. Anthony, W. Read, P. Rosen, R. Tibes, D. Park, R. Korn, D. Everton, B. Tseng, J. Whisnant, D. Von Hoff. Abstract ID: 2531 Poster Session: Developmental Therapeutics: Molecular Therapeutics Poster Board #: 1 Date: May 31, 2008 Time: 8am-12pm Location: W375e Lobby The authors of the poster concluded that EPC2407 studied in 17 patients is a safer and easier to use agent than previous VDA's. The dose limiting toxicity profile of EPC2407 is consistent with its mode of action and pre-clinical studies. EPC2407 caused no thrombocytopenia, leucopenia or neutropenia at any dose studied. It has not caused renal or hepatic dysfunction as well. EPC2407 has been well tolerated by several patients for four or more cycles with stable disease for at least three month's duration. CT perfusion studies indicate objective signs of efficacy in these resistant patients as noted by changes in tumor perfusion and other measures of anti-tumor activity. Of the nine patients who have undergone CT perfusion to date: six of the nine had stable disease as measured by RECIST criteria; 2 of the nine had unconfirmed stable disease; and one had progressive disease. Jack Talley, CEO of EpiCept, commented, "EPC2407 appears to be an active new VDA, causes direct apoptosis and has an acceptable safety profile to date for combination therapy." He also added, "We are encouraged by these results and optimistic to initiate a combination study in resistant solid tumors before the end of the year." About EPC2407 EPC2407 has shown promising vascular targeting activity with potent 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. EpiCept intends to begin a Phase Ib combination trial for EPC2407 with other anti-cancer agents later this year. In preclinical tumored animal models, combination therapy has demonstrated synergistic activity. EPC2407 is one of two compounds currently in clinical trials discovered through EpiCept's Anti-cancer Screening Apoptosis Program (ASAP). The second compound, MPC-6827, is part of the EP90745 series of apoptosis inducers licensed by EpiCept to Myriad Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement. Myriad previously announced that MPC-6827, developed under the trademark Azixa(TM), has a second mode of action due to vascular disruption activity. The compound is currently being evaluated in three Phase II human clinical trials, one in patients with primary brain cancer and the others in brain metastases due to melanoma and in non-small cell lung cancer. 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 Corporation EpiCept is focused on unmet needs in the treatment of cancer and pain. The Company's broad portfolio of pharmaceutical product candidates includes several pain therapies in clinical development and a lead oncology compound for AML with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound recently received a negative opinion and is being re-examined in Europe. In addition, EpiCept's ASAP technology, a proprietary live cell high-throughput caspase-3 screening technology, can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells. Two oncology drug candidates currently in clinical development that were discovered using this technology have also been shown to act as vascular disruption agents in a variety of solid tumors. 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 risks associated with the adequacy of our existing cash resources and our need to raise additional financing to continue to meet our capital needs and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements or that we may default on our loans or that our lenders may declare the Company in default or that our secured lender would seek to sell our assets, the risk that the Company's securities may be delisted by the Nasdaq Capital Market and that any appeal of the delisting determination may not be successful, the risk that our appeal of the negative opinion regarding the MAA for Ceplene(R) will not be successful and that Ceplene(R) will not receive regulatory approval or marketing authorization in the EU, the risk that Ceplene(R), if approved, will not achieve significant commercial success, the risk that Myriad's development of Azixa(TM) will not be successful, the risk that Azixa(TM) 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 or EPC2407 will not be successful, the risk that NP-1 or EPC2407 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 we will not obtain approval to market any of our product candidates, 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; the highly competitive nature of our business; risks associated with litigation; 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. EPCT-GEN *Azixa is a registered trademark of Myriad Genetics, Inc. EpiCept Corporation: Robert W. Cook, 914-606-3500 rcook@epicept.com Or Media: Feinstein Kean Healthcare Greg Kelley, 617-577-8110 gregory.kelley@fkhealth.com Or Investors: Lippert/Heilshorn & Associates Kim Sutton Golodetz, 212-838-3777 kgolodetz@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com
EpiCept Announces Presentation of EPC2407 Data at 2008 American Society of Clinical Oncology Annual Meeting
| Source: Immune Pharmaceuticals Inc