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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM)

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From: Icebrg	12/8/2007 10:04:03 AM
	of 3044

AVE1642 Clinical Findings Reported AVE1642 is a “naked” (non-conjugated) antibody that binds to IGF-1R. It is designed to block a pathway that is used by cancer cells to survive chemotherapy treatments. AVE1642 was initially developed by ImmunoGen and was licensed to sanofi-aventis as part of a broader collaboration between the companies. The findings reported today are from a Phase I study in which AVE1642 is administered as monotherapy to patients with advanced multiple myeloma. As the compound is designed to be used in combination with chemotherapy, the purpose of this study was to determine the “selected dose” – the AVE1642 dose to be used in further evaluation of the compound. Three dose levels were evaluated, and the highest dose – 12 mg/kg given every three weeks – was chosen as the selected dose based on pharmacokinetic and pharmacodynamic parameters. AVE1642 was well tolerated and DLT was not observed. Two diabetic patients in the study had Grade 3 hyperglycemia, which was readily reversible. While this study was not designed to assess the activity of AVE1642, the investigators noted that a patient with Bence-Jones multiple myeloma experienced a decrease in proteinuria and relief of bone pain following treatment with AVE1642. Once the selected dose was established for AVE1642, sanofi-aventis initiated two additional Phase I trials with the compound. * Sanofi-aventis began evaluation of AVE1642 for the treatment of solid tumors. The compound is administered as monotherapy in the Phase I trial currently underway. * Sanofi-aventis also advanced the evaluation of the compound for the treatment of hematological or “liquid” tumors by starting a Phase I study that assesses AVE1642 when used in combination with Velcade in patients with relapsed/refractory multiple myeloma. In this trial, AVE1642 is administered at 12 mg/kg every three weeks and Velcade is administered at its approved dosing schedule (1.3 mg/m2 given on Days 1, 4, 8, and 11 every three weeks). AVE1642 has been shown to have synergistic activity when given in combination with Velcade in preclinical studies. “These data are highly promising and show the synergistic combination of our clinical development expertise and ImmunoGen’s antibody expertise,” stated Sylvain Durrleman, MD, Vice President, Clinical Development, sanofi-aventis. “We are enthusiastic about the anticancer potential offered by AVE1642.”

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