Healthcare Industry News: EpiCept
News Release - December 15, 2010
EpiCept Announces Initiation by NCI of Phase II Trial with Crolibulin(TM) in Anaplastic Thyroid CancerTARRYTOWN, N.Y.--(Healthcare Sales & Marketing Network)-- EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that the National Cancer Institute (NCI) has initiated a Phase II trial with crolibulinTM (EPC2407). The trial will assess the drug’s efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (ATC). CrolibulinTM is a vascular disruption and apoptosis inducing agent that has demonstrated potent anti-tumor activity in both preclinical and early clinical studies.
The Phase II trial consists of two stages. The primary objective of the first stage is to assess the safety and tolerability of cisplatin and crolibulinTM given in 21-day treatment cycles. The study will assess the toxicities of crolibulinTM co-administered with cisplatin, evaluate dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the combination. The primary objective in the second stage of the trial will be to compare the combination of crolibulinTM and cisplatin against cisplatin alone in adult ATC patients by assessing the duration of progression-free survival (PFS). An important secondary objective is the comparison of the response rates evaluated by RECIST (Response Evaluation Criteria in Solid Tumors). Up to 70 patients are planned to be enrolled in the trial.
The NCI is assessing crolibulinTM based upon its early clinical data and activity observed in resistant solid tumors. Crolibulin™’s dual mechanism of action through its vascular disruptive and direct apoptotic activity may have an impact on the treatment of this disease. ATC is an extremely aggressive cancer that has a median survival of four to five months from the time of diagnosis. Few patients survive more than one year. Treatment for most patients is generally palliative, indicating a profound unmet medical need.
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®, approved in the EU for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. In the U.S., a pivotal trial is scheduled to commence in 2011. In a randomized clinical trial, Ceplene® has shown a trend to extend life in AML patients treated with high intensity chemotherapy by more than three years. In addition to crolibulin™, EpiCept’s clinical pipeline includes Azixa™, under development by Myrexis for various forms of brain cancer, and EpiCept™ NP-1, a topical cream for the treatment of various neuropathies. Results from a double-blind, placebo-controlled Phase IIb trial of NP-1 in chemotherapy-induced peripheral neuropathy are expected to become available in the next few weeks.
Crolibulin™ is a novel small molecule vascular disruption agent and apoptosis inducer for the treatment of patients with advanced solid tumors. Crolibulin™ has shown promising vascular targeting activity with potent anti-tumor activity in preclinical 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 Crolibulin™ inhibits growth of established tumors of a number of different cancer types.
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements that 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 Ceplene® will not receive regulatory approval or marketing authorization in the United States the risk that Ceplene® will not achieve significant commercial success, 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 future financing will not successfully close or that the proceeds thereof will be materially less than anticipated, 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 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 Myrexis, the risk that the development of our other apoptosis product candidates will not be successful, the risk that clinical trials for EpiCept™ NP-1 or crolibulinTM will not be successful, the risk that EpiCept™ NP-1 or crolibulinTM 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 EpiCept™ 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; the risk that our securities may be delisted from Nasdaq; 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 Myrexis, Inc.
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