Roche (RHHBY) Release: Xeloda(R) Combination Meets Primary Endpoint In International Phase III Advanced Colorectal Cancer Study

NUTLEY, N.J.-- Roche announced today that a large, international Phase III study (NO16967) of 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival. Study results showed that the chemotherapy combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).

"Our data complement the findings of the NO16966 study, suggesting that XELOX is a very reasonable treatment option for patients with recurrent colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor of Medicine at Vanderbilt University Medical Center and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer."

Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2006, more than 148,000 people in the U.S. will be diagnosed and about 55,000 people will die from the disease.

5 fluoro-uracil is specific for thymidine phosphorylase and inhibits it. TP is upregulated in tumor cells which makes 5FU an attractive drug given it's specificity. TP is associated/upregulated with tumor angiogenesis ( new blood vessels ). I think that the market impact of this rather nice since it's a prodrug, meaning that it is inactive until converted to the active form in the body, thus improving the specificity and pinpoint drug concentrations at tumor sites.


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