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Millennium Pharma -2: Drug Study Shows 35% Response Rate

Millennium Pharmaceuticals, Inc. (MLNM) said final results from the phase II study of its cancer drug Velcade indicated the drug was successful at slowing development of relapsed and refractory multiple myeloma, which attacks bone marrow through the overproduction of white blood cells.

In a press release Monday the Cambridge, Mass. biopharmaceutical company said the findings indicated that a majority of patients in the study experienced a reduction or stabilization of their disease severity, with some patients experiencing complete remissions.

The results were announced Monday at the 44th annual meeting of the American Society of Hematology in Philadelphia.

The multi-center phase II study included 202 patients with refractory and relapsing multiple myeloma who had an expected survival of six to nine months and who had averaged six prior therapeutic regimens for their cancer.

Study results from the 193 evaluable patients showed complete remissions in 4% of patients as defined by Blade criteria and an additional 6% of patients who had a 100% reduction in M-protein, a marker of tumor burden, but a positive immunofixation test (a sensitive antibody test for trace amounts of M-protein). The overall response rate was 35%, defined as the combined total of complete and partial remissions and minimal responses. Overall, 59% of patients experienced a response or achieved stable disease.

Last week Millennium said it would submit a New Drug Application by early 2003 to market Velcade as a treatment for relapsed and refractory multiple myeloma.

Earlier this year, Velcade was granted fast-track status by the Food and Drug Administration as having the potential to treat the life-threatening condition. Millennium also plans to file a marketing authorization application to the European Agency for the Evaluation of Medicinal Products by early 2003.

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