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IMCLONE BEGINS SOLID TUMOR TREATMENT STUDY

January 5, 2007

ImClone Systems has initiated patient treatment in a Phase I clinical trial of its fully human IgG1 monoclonal antibody targeting the platelet derived growth factor receptor (PDGFR) alpha, IMC-3G3, in patients with solid tumors.

This study will be conducted at two clinical sites in the U.S. and is designed to establish the safety profile of IMC-3G3 and to evaluate the pharmacokinetics and pharmacodynamics of the new antibody administered weekly by intravenous infusion. The trial is expected to enroll approximately 30 to 40 patients.

Platelet-derived growth factor (PDGF) is known to regulate cell growth and division, according to ImClone. One of the receptors for PDGF, PDGFR alpha, is expressed on a number of human cancers and on accessory cells in tumors that are important for sustaining tumor growth.

Studies have shown that PDGFR alpha plays an important role in regulating VEGF-driven tumor angiogenesis. Therapeutic intervention with a PDGFR alpha antibody, such as IMC-3G3, may provide another means to blocking tumor growth and angiogenesis in human cancers, and possibly an approach to overcome resistance to current VEGF-targeted therapies, according to the company.

IMC-3G3 is a fully human IgG1 monoclonal antibody that is designed to bind to PDGFR alpha, leading to inhibition of ligand-dependent signaling in PDGFR-alpha-expressing tumor cells, as well as stromal cells in the tumor microenviroment that are dependent on PDGFR alpha signaling. Treatment with IMC-3G3 in preclinical models of human breast, hepatocellular, ovarian and prostate carcinoma has resulted in significant reduction of cancer cell proliferation and tumor growth.