Healthcare Industry News:  EpiCept 

Biopharmaceuticals Oncology FDA

 News Release - October 2, 2006

EpiCept Announces IND Filing of Novel Compound with Potent Apoptotic and Tumor Selective Vascular Disruptive Activity for Treatment of Cancer

EPC2407 Latest Clinical Candidate from Company's Apoptosis Screening Technology

ENGLEWOOD CLIFFS, N.J., Oct. 2 (HSMN NewsFeed) -- EpiCept Corporation (Nasdaq: EPCT; OMX Stockholm) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin Phase I clinical studies of EPC2407 in cancer patients. EPC2407 is the Company's novel small molecule which induces apoptosis (cell death) and disruption of tumor blood flow. EPC2407 is intended for the treatment of advanced cancer patients with solid tumors that are well vascularized. These tumors include the frequently occurring cancers of the lung, ovaries, and breast. These cancers still have a high mortality rate despite progress in earlier stages of these diseases.

EPC2407 is the first of a new class of microtubulin inhibitors which cause cell cycle arrest, caspase activation and apoptotic death in cancer cells. The compound has demonstrated in pre-clinical studies potent anti-tumor activity against a number of tumor types and is synergistic with cisplatin. EPC2407 also disrupts the vasculature of tumor blood vessels leading to hypoxia and tumor necrosis. This has been shown to occur in pre-clinical studies in tumored animals at subtoxic concentrations. The objectives of this first clinical trial of EPC2407 is to determine the maximum tolerated dose, to characterize the blood levels and biological effects of the drug and to identify any anti-tumor response as measured by CT scans, MRI or PET scans. The study is expected to enroll approximately 30-40 patients.

One of the investigators for this study is Dr. Daniel von Hoff from the Center for Translational Drug Development, TGen, the Scottsdale Healthcare Clinical Research Institute and the Arizona Cancer Center. Dr. von Hoff commented, "We are pleased to work with EpiCept Corporation to test this potential new anti-cancer compound in patients with advanced cancers. Results from pre-clinical testing of EPC2407 are encouraging, and mechanism studies suggest two ways that this new agent may add to our treatment options for a range of cancers."

"The filing of an IND for EPC2407 represents an important milestone for our company," stated Jack Talley, President and Chief Executive Officer. "We believe this filing deepens our already promising clinical pipeline of pain and cancer treatment candidates and further demonstrates the potential of our proprietary apoptosis screening technology which led to the discovery and development of EPC2407. This compound represents the second clinical cancer candidate discovered by EpiCept researchers utilizing this technology. We have identified several other promising compounds with the potential for further development which we intend to selectively pursue. Our goal is to progress these product candidates into clinical development and seek partners prior to the commencement of pivotal scale trials."

About EPC2407

The IND filing for EPC2407 is based on the compound's effectiveness in several pre-clinical animal models of cancer and its potent anti-tumor effects both in vitro and in vivo. Nanomolar concentrations of the molecule have been shown to induce tumor cell apoptosis and to selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts demonstrated that EPC2407 inhibits growth of established tumors of a number of different cancer types. The safety profile of the compound in standard toxicology studies also supports its testing in human clinical trials.

Pre-clinical studies suggest that the anti-tumor effects of EPC2407 may be the result of a dual mechanism, a direct effect of tumor apoptosis and a second effect on disruption of tumor vascular endothelial cells leading to hypoxia and central tumor necrosis, as observed with vascular disruption agents.

About EpiCept's Apoptosis Screening Technology

Cancer cells often exhibit unchecked growth caused by the disabled or absent natural process of programmed cell death called apoptosis. Apoptosis is a normal process of triggering destruction of cells from within when they have outlived their purpose or may be seriously damaged, but cancer cells grow out of control when the normal apoptosis process is not functioning. A promising approach in the fight against cancer is selective induction of or restoration of apoptosis, 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 based on the cellular activity of a protein, enabling researchers to determine the protein's function. With the combination of chemical genetics and caspase-3 screening, EpiCept's researchers identify and test the effect of small molecules on pathways and molecular targets crucial to apoptosis and gain insights into their potential as new anticancer agents. The Company's screening technology is particularly versatile and can be adapted for many cell types that can be cultured, and it can 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's drug discovery and pre-clinical development groups include high throughput screening (HTS) and informatics, cell biology, medicinal chemistry, and in vivo pharmacology. The HTS group identifies the hits which upon passing certain criteria are analoged by the chemistry group for secondary and tertiary assay testing by the cell biology group. Promising leads are tested in animal models for toxicity, efficacy and pharmacokinetics. An iterative interaction between the various groups provides for the rapid advancement from hit compounds to lead candidates suitable for further development.

About EpiCept Corporation

EpiCept is an emerging specialty pharmaceutical company focused on unmet needs in the treatment of pain and cancer. The Company has a staged portfolio of product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, AML) with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound will be submitted in Europe in the near future. EpiCept is based in New Jersey, and the Company's research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the efficacy, safety, and intended utilization of the Company's product candidates, the conduct and results of future clinical trials, the sufficiency of the Company's existing capital resources, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that 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 the Company will not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in the Company's periodic reports and other filings with the SEC.

Source: EpiCept

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