EpiCept Announces EPC2407 Generic Name is Crinobulin TARRYTOWN, N.Y.--(BUSINESS WIRE)-- EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that the United States Adopted Names Council (USAN) has approved “crinobulin” as the generic name for EPC2407, the company's novel, small molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas. Crinobulin has shown promising vascular targeting activity with potent anti-tumor activity in both pre-clinical and early clinical studies. In pre-clinical in vitro and in vivo studies, crinobulin 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 that crinobulin inhibits growth of established tumors of a number of different cancer types. In terms of clinical activity, the preliminary results of 33 patients treated in a Phase I dose escalating monotherapy study provided visible radiographic evidence of vascular disruptive activity. A wide variety of advanced tumor types, including hepatic, pancreatic, non-small cell lung, colon, prostate and gastrointestinal cancers, as well as metastatic melanoma, and parotid carcinoma - have been treated with crinobulin. Crinobulin, administered over a four-hour intravenous infusion for a cycle of three days, caused no thrombocytopenia, leucopenia, or neutropenia at any dose studied. In addition, it did not cause renal or hepatic dysfunction. Crinobulin has been well tolerated and administered for up to eight cycles with stable disease for six month's duration. EpiCept is currently evaluating the pharmacokinetic and pharmacodynamic effects of crinobulin with different dosage schedules from the Phase I study and expects to initiate a Phase Ib combination trial with crinobulin in combination with other chemotherapeutic agents in the second half of 2009. 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 Ceplene®, a cytokine immunomodulator that recently received marketing authorization in Europe for the remission maintenance of AML patients, and several pain therapies in clinical development. Two oncology drug candidates currently in clinical development that were discovered using in-house 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 our 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 our announced public offering will not close, risks associated with the adequacy of our existing cash resources 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, the risk that our securities may be delisted by The Nasdaq Capital Market or the OMX Nordic Exchange and that any appeal of the delisting determination may not be successful, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the U.S. or Canada, the risk that Ceplene® will not be launched in Europe in the first half of 2009 or achieve significant commercial success, the risk that we are unable to find a suitable marketing partner for Ceplene® on attractive terms, a timely basis or at all, the risk that any required post-approval clinical study will not be successful, the risk that we will not be able to maintain its final regulatory approval or marketing authorization, 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 we will not be able to find a buyer for our ASAP technology, the risk that clinical trials for NP-1 or crinobulin will not be successful, the risk that NP-1 or crinobulin will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for NP-1 on attractive terms or a timely basis at all, 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 other product candidates, the risks associated with our 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 our 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 our 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 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 EPC2407 Generic Name is Crinobulin
| Source: Immune Pharmaceuticals Inc