EpiCept Announces Positive Clinical Data from EPC2407 Phase I Cancer TrialTARRYTOWN, N.Y.--(BUSINESS WIRE)--April 7, 2008 - EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today released clinical study results from the Phase I trial of EPC2407, which provided visible evidence of vascular disruptive activity. 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 has recently analyzed the imaging data from the first eight patients enrolled in the study who had measurable Computed Tomography (CT) perfusion scans. These patients received doses of EPC2407 ranging from 4mg/kg to 13mg/kg in three different cohorts. The results indicated that the disease had stabilized in seven of the eight patients studied. The CT perfusion scan measurements indicated that overall blood perfusion in the tumor decreased with EPC2407 treatment in the second and third cohorts, indicating an effective VDA dose had been reached. These data were measured five days after the last dose in a cycle, suggesting a sustained effect after dosing. In addition, the patients with stable disease over several treatment cycles had the greatest decreases in tumor perfusion as well as results indicative of decreased blood flow and decreased blood volume to the tumor, all suggesting a potential anti-tumor response.
The anti-cancer effect of EPC2407 was seen across a wide variety of advanced tumor types including patients with: pancreatic, non-small cell lung cancer, colon, prostate, gastrointestinal, metastatic melanoma, and parotid carcinoma. Patients were treated with up to five cycles of EPC2407.
Jack Talley, President and CEO of EpiCept Corporation, stated, "These data are strong evidence of VDA activity in patients enrolled in the trial and confirm previously published animal data that demonstrated the ability of EPC2407 to inhibit tumor growth in various cancers. We look forward to sharing these data more fully at upcoming cancer meetings later this year. We also are continuing our preparations for a Phase Ib trial for EPC2407 in combination with other chemotherapeutic agents, which we anticipate will commence later this year."
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.
In October 2007, EpiCept announced the successful completion of the Phase I clinical trial for EPC2407, with all of the trial's objectives having been met. The Company has since decided to further enroll additional patients with an extended infusion time for the drug in order to determine whether higher doses can be tolerated.
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'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. ASAP 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. 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 is being re-examined in Europe following a negative opinion. 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.
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 our need to raise additional financing to continue to meet our capital needs and our ability to continue as a going concern, the risk that Ceplene(R) will not receive regulatory approval or marketing authorization in the EU or that any appeal of an adverse decision will not be successful, 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; 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 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.
Robert W. Cook, 914-606-3500
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
Bruce Voss, 310-691-7100
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
Posted: April 2008