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Cetuximab Phase 3 Trial Fails to Meet Primary Endpoint of Progression-Free Survival

NEW YORK, July 12 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced results from an open-label phase 3 study of cetuximab (Erbitux) plus a taxane and carboplatin in the first-line treatment for metastatic non-small cell lung cancer (NSCLC). The study did not meet its primary endpoint of progression-free survival (PFS) as assessed by an independent radiology review committee (IRRC). However, key secondary endpoints of the study, including response rate as assessed by the IRRC and PFS as assessed by clinical investigators, were statistically significant and favored the Erbitux-containing arm.

Known as BMS CA225-099, this study included more than 600 patients from the United States and Canada and was one of several clinical trials intended to establish the role of Erbitux in the treatment of advanced NSCLC. Data from the largest of these trials, an ongoing multinational Phase III study of Erbitux plus cisplatin and vinorelbine intended to be the pivotal study for the Erbitux NSCLC regulatory strategy, are not yet available.

"We consider lung cancer to be a high priority and await the results of other Phase II and Phase III evaluations of Erbitux in the first- and second- line setting with chemotherapy regimens," stated Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.

"Lung cancer is a devastating disease with few effective treatment options," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb. "Efforts to fully interpret these results are ongoing, and the companies plan to submit the data from this study to an upcoming medical meeting in 2007."

About Lung Cancer
The American Cancer Society estimates that in the U.S., more than 213,000 people will be diagnosed with lung cancer in 2007. Lung cancer is the leading cause of cancer-related death in men and women in the U.S., with 160,000 deaths estimated in 2007. Approximately 80 to 85 percent of these patients will be diagnosed with NSCLC, with the majority being diagnosed with locally advanced or metastatic disease.

About cetuximab (Erbitux)
Erbituxis 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 Erbituxto 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’s 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.

Cetuximab (Erbitux), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. Erbituxas 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.

Erbituxis 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.

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Source: ImClone Systems and Bristol-Myers Squibb

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