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Bortezomib Phase II Colorectal Trial Closed

CAMBRIDGE, Mass., Jan. 6 /PRNewswire-FirstCall/-- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today clarified that based on the completion of a pre-specified interim analysis, the Company has decided to stop further accrual to its phase II trial examining the utility of VELCADE(TM) (bortezomib) for Injection either alone or in combination with Camptosar(R) (irinotecan hydrochloride injection) in patients with metastatic colorectal cancer previously refractory to Camptostar. This decision was based on interim findings from both arms of the study that produced results that do not meet the pre-specified efficacy criteria for continuation of study accrual. An update on the complete findings of this analysis will be provided at a medical meeting in 2004.

Although accrual has been closed, patients currently in the study experiencing clinical benefit may continue to receive treatment. Additional NCI and investigator-sponsored studies examining the utility of VELCADE in combination with other agents for the treatment of patients with non- refractory colorectal cancer are ongoing or planned.

The Company continues to investigate the full potential of VELCADE in both hematologic and solid tumors and currently has over 50 ongoing or planned clinical trials.

About VELCADE(TM) (bortezomib) for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma - a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration (FDA) on May 13, 2003 to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival.

VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

In 228 patients who were treated with VELCADE in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent) and nausea (4 percent).

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.

Source: Millenium Pharmaceuticals

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