Follow up Combination Therapy Trial planned for 2008
TARRYTOWN, N.Y., Oct. 8 /PRNewswire-FirstCall/ -- EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has completed its Phase I clinical trial for EPC2407. The trial has met all of its objectives. 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.
EpiCept successfully identified the maximum tolerated dose of EPC2407 in the Phase I study. The maximum tolerated dose was well below the dose which produced the expected toxicity based on preclinical studies at higher doses. EPC2407 was administered as a single agent in increasing doses to small cohorts of patients with advanced solid tumors. A total of seventeen patients were enrolled in the study. The drug was tested in a variety of cancer types including melanoma, prostate, lung, breast, colon, and pancreatic cancers. The study, which was initiated in December 2006, was conducted at three cancer centers in the U.S.
"We are pleased that this milestone has been reached," stated Jack Talley, President and Chief Executive Officer. "We are now in the process of meeting with our advisors to move forward with a Phase Ib combination trial for the drug with other chemotherapeutic agents. Preclinical data in mouse xenograft models indicate there is either additive or synergistic activity when EPC2407 is used in combination with other cancer therapeutic agents including Cisplatin, Sutent(R)* and Avastin(R)*. We anticipate being able to initiate this combination trial in early 2008."
In addition to determining the maximum tolerated dosage of the EPC2407, the primary objective of the study was to determine the pharmacokinetic profile of the drug. Results from the study will also help characterize the pharmacodynamic effects on tumor blood flow and potentially identify early signs of objective anti-tumor response as measured by CT scans, MRI or PET, in advanced cancer patients with well vascularized solid tumors.
Mr. Talley continued, "Our advancement of EPC2407 and the regulatory progress we announced earlier this month on Ceplene(TM), demonstrates the opportunities inherent in our pursuit of both early- and late-stage cancer programs, and, when combined with our pipeline of pain candidates, illustrates the long-term potential offered by our company."
EPC2407 was discovered through EpiCept's Anti-cancer Screening Apoptosis Program (ASAP), a proprietary technology used to rapidly test and generate product candidates for cancer. EPC2407 has shown promising vascular targeting activity with nanomolar potencies of 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 more effectively than the other VDAs tested and was synergistic when used in combination with anticancer agents, such as Cisplatin. EPC2407 is one of two VDA compounds currently in clinical trials discovered through EpiCept's ASAP technology. The second compound, Azixa(TM), is part of the EP90745 series of apoptosis inducers, which was licensed by EpiCept to Myriad Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement.
About EpiCept's ASAP Technology
Cancer cells often exhibit unchecked growth caused by the disabling or absence of the natural process of programmed cell death, which is called apoptosis. Apoptosis is normally triggered to destroy a cell from within when it outlives its purpose or it is seriously damaged. One of the most promising approaches in the fight against cancer is to selectively induce apoptosis in cancer cells, thereby checking, and perhaps reversing, the improper cell growth.
EpiCept's proprietary apoptosis screening technology can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells through the use of chemical genetics and its proprietary live cell high-throughput caspase-3 screening technology. Chemical genetics is a research approach investigating the effect of small molecule drug candidates on the cellular activity of a protein, enabling researchers to determine the protein's function. Using this approach with its proprietary caspase-3 screening technology, EpiCept researchers can focus their investigation on the cellular activity of small molecule drug candidates and their relationship to apoptosis.
This combination of chemical genetics and caspase-3 screening technology allows EpiCept's researchers to discover and rapidly test the effect of small molecules on pathways and molecular targets crucial to apoptosis, and gain insights into their potential as new anticancer agents. This screening technology is particularly versatile and can be adapted for almost any cell type that can be cultured, as well as measure caspase activation inside multiple cell types (e.g., cancer cells, immune cells, or cell lines from different organ systems or genetically engineered cells). This allows researchers to find potential drug candidates that are selective for specific cancer types, which may help identify candidates that provide increased therapeutic benefit and reduced toxicity.
EpiCept has identified several families of compounds with potentially novel mechanisms that induce apoptosis in cancer cells. Several compounds from within these families have progressed to lead drug candidate status with proven pre-clinical efficacies in tumor models and identified molecular targets.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer. EpiCept has a staged portfolio of pharmaceutical product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound has been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
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 clinical trials for EPC2407 will not be successful, that EPC2407 will not receive regulatory approval or achieve significant commercial success, the risk that Ceplene will not receive regulatory approval or marketing authorization in the EU or that Ceplene, 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 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 will not be successful, that NP-1 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 EpiCept will not obtain approval to market any of its product candidates, the risks associated with reliance on additional outside financing to meet its capital requirements, 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; competition; litigation; risks associated with prior material weaknesses in our internal controls; 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 http://www.sec.gov or at http://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.; Sutent is a
registered trademark of Pfizer Inc.; Avastin is a registered trademark of
|SOURCE EpiCept Corporation|
Copyright©2007 PR Newswire.
All rights reserved