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Millennium Starts Phase I Trials

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Millennium, a division of Takeda, has begun two Phase I trials of MLN4924, a first-in-class, small molecule inhibitor of the Nedd 8 Activating Enzyme (NAE), a target discovered by the company. MLN4924 advanced to the clinic with the first patient dosed in April 2008. The two Phase I dose escalation studies aim to assess safety, tolerability, pharmacokinetic and pharmacodynamic effects in patients with advanced solid tumors or with hematological malignancies.

Millennium also began a Phase I hematologic trial of MLN8237, a first-in-class, specific Aurora A kinase inhibitor, based on preclinical data on the role of Aurora A in lymphomas and other hematologic tumors. Preclinical results also showed substantial activity in pediatric neuroblastoma and acute lymphocytic leukemia (ALL). Millennium plans to expand the program into Phase II trials in late 2008/early 2009.

“The progress of these two Millennium-discovered oncology drugs is important to our goal of bringing innovative medicines to cancer patients,” said Nancy Simonian, M.D., Millennium’s chief medical officer. “The emerging data associated with MLN4924 and MLN8237 support our vision of solidifying Takeda as a leader in oncology discovery and development by 2020.”

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