EpiCept Announces Presentation of New Crinobulin Data at 2009 American Society of Clinical Oncology Annual Meeting
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it will present data from its Phase Ia trial of crinobulin at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place May 29 to June 2, 2009 in Orlando, Florida. Crinobulin 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 #3569 - General Poster Session, Developmental Therapeutics: Molecular Therapeutics, Saturday, May 30, 2009, 8:00am-12:00pm EDT, Level 2, West Hall C
Title: "Pharmacokinetic and pharmacodynamic results of a 4-hr IV administration phase I study with EPC2407, a novel vascular disrupting agent.”
The authors of the poster evaluated the pharmacokinetic and pharmacodynamic effects of crinobulin with different dosing schedules. Prolonged infusion of crinobulin to extend exposure of tumor vasculature was designed with administration of the compound over four hours for three consecutive days of a 21-day cycle. Crinobulin demonstrated the infusion-associated toxicities characteristic of the VDA drug class but without sustained or cumulative toxicity. Increasing the infusion duration from 1 hour to 4 hours permitted an approximate 50% increase in the amount of drug that could be tolerated. Furthermore, this monotherapy trial in advanced resistant patients showed encouraging results in selected patients with hepatocellular carcinoma. Early MRI results also documented a vascular disruptive effect in these patients as evidenced by decreases in tumor permeability and tumor perfusion.
Jack Talley, President and CEO of EpiCept, commented, “The results of this study further expands the body of clinical data showing the clinical promise for crinobulin. We are encouraged by these results and intend to initiate a Phase 1b combination trial for the compound with other chemotherapeutic agents in the second half of this year.”
Crinobulin has demonstrated potent anti-tumor activity in both preclinical and early clinical studies. In preclinical 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. In April 2008 EpiCept announced positive clinical data from a Phase I study of crinobulin in patients with solid tumors.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene®, which has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia in first remission. The Company has two oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCeptTM NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
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 we will not have sufficient authorized shares of stock to raise equity capital, the 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 United States or Canada, the risk that Ceplene® will not be launched in Europe in the second 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 for Ceplene® will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene®, 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 EpiCeptTM NP-1 or crinobulin will not be successful, the risk that EpiCeptTM 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 EpiCeptTM NP-1 on attractive terms, a timely basis or 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 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 our periodic reports, including our 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.
*Azixa is a registered trademark of Myriad Genetics, Inc.
Contact: EpiCept Corporation:
Robert W. Cook, 914-606-3500
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
Bruce Voss, 310-691-7100
Posted: May 2009