Pharmaceutical Business review

Millennium initiates Phase I studies for cancer drug

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.

In addition, the company has initiated a Phase I hematologic trial of MLN8237, a specific Aurora A kinase inhibitor based on emerging pre-clinical data on the role of Aurora A in lymphomas and other hematologic tumors.

Pre-clinical results also showed substantial activity in pediatric neuroblastoma and acute lymphocytic leukemia. Millennium plans to expand the program into Phase II trials in late 2008/early 2009.

Nancy Simonian, chief medical officer of Millennium, said: “The emerging data associated with MLN4924 and MLN8237 support our vision of solidifying Takeda as a leader in oncology discovery and development by 2020.”