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Phase 3 Trial of Cetuximab Chemo Combo Meets Primary Endpoint of Increased Duration of Progression-Free Survival

NEW YORK, Jan. 10 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (NASDAQ:IMCL) and Bristol-Myers Squibb Company (NYSE:BMY) today announced that a Phase III study of Erbitux (cetuximab) plus FOLFIRI (an irinotecan- based chemotherapy) met the primary endpoint of increasing median duration of progression-free survival over FOLFIRI alone in patients with previously untreated metastatic colorectal cancer (mCRC). More than 1,000 patients were recruited from around the world to participate in the study, known as the CRYSTAL(1) study.

"Despite advancements, metastatic disease remains difficult to treat. This study demonstrates the potential benefit of adding Erbitux to first-line treatment of metastatic colorectal cancer," said Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.

"These results provide important new information for patients with metastatic colorectal cancer, and are part of a comprehensive clinical development program designed to fully understand the potential uses of Erbitux for cancer patients," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb.

The study was conducted by Merck KGaA, Darmstadt, Germany, ImClone Systems' Erbitux partner outside of North America. Results have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.

About Erbitux (Cetuximab)
Erbitux is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of Erbitux to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, Erbitux can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. While the mechanism of Erbitux' anti-tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of Erbitux. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

Erbitux (cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. Erbitux as a single agent is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

Erbitux is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy. The effectiveness of Erbitux for the treatment of EGFR-expressing mCRC cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux for the treatment of EGFR-expressing mCRC.

For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit

Source: ImClone Systems Incorporated and Bristol-Myers Squibb Company

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