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Hotty Miss  |  by www.tradingmarkets.com. All rights reserved. 13.11 | 23:23

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(RTTNews) - Early Monday, pharmaceutical companies Bristol-Myers Squibb Co. ( | | | ) and ImClone Systems Inc. ( | | | ) revealed results from two randomized Phase III trials of ERBITUX or cetuximab in patients with metastatic colorectal cancer.

According to the company, these are the first randomized studies to examine the impact of ERBITUX treatment on overall survival in colon cancer. The company noted that the Phase III trial compared ERBITUX and best supportive care to best supportive care alone in 572 patients with metastatic colorectal cancer. The cancer of allthis 572 patients were refractory to all available chemotherapy, including irinotecan, oxaliplatin, and fluoropyrimidines.

The study, conducted by the National Cancer Institute of Canada Clinical Trials Group or NCIC CTG in collaboration with the Australasian Gastro-Intestinal Trials Group or AGITG, met its primary efficacy endpoint showing a statistically significant improvement in overall survival. According to the company, these are the first data of an anticancer therapy to demonstrate overall survival in this refractory treatment setting. The NCIC CTG is scheduled to submit the data from this study for presentation at a major medical meeting in 2007.

A second Phase III, randomized study for ERBITUX with Irinotecan in Colorectal Cancer, compared to irinotecan alone in about 1,300 patients whose disease were with absence of response to first-line oxaliplatin-based chemotherapy. After randomization, patients were treated until their disease progressed and after progression, study treatment was stopped and further treatment was at the discretion of the physician. Secondary efficacy endpoints such as progression free survival and response rate strongly favored the combination of ERBITUX plus irinotecan over irinotecan alone; however, the primary endpoint of overall survival was not met.

IMCL closed Friday's regular trading session at $31.04, up $0.14, on a volume of 727K shares, while shares of BMY closed Friday's regular trade at $24.

53, up 0.06, on a volume of 6.24 million shares.

Read more on by www.tradingmarkets.com. All rights reserved.
Keywords: Phase Iii, Colorectal Cancer, Ncic Ctg, Trials Group
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