Millennium Initiates Two Phase Il Trials of Aurora A Kinase Inhibitor
News Mar 04, 2009
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc., announced that Millennium has initiated two Phase II clinical trials of MLN8237.
The first trial will examine the molecule in adult patients with aggressive non-Hodgkin’s lymphoma (NHL), while the second trial will evaluate the drug in patients with acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS). MLN8237 is an oral, selective Aurora A kinase inhibitor discovered and developed by Millennium scientists.
“We are very excited to begin these studies examining MLN8237 in several hematologic malignancies,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “This novel target is the latest drug candidate in our expanded oncology pipeline to enter Phase II clinical trials and helps move Millennium and Takeda toward the goal of becoming a global oncology leader.”
Both trials will be open-label, multi-center trials for patients with relapsed or refractory aggressive NHL, AML and MDS. Endpoints to be examined include response rates, time to progression and safety and tolerability. These trials are the first of a broader Phase II program examining the use of MLN8237 in both solid tumors and hematologic malignancies. An additional study is ongoing with the Children’s Oncology Group examining MLN8237 in pediatric neuroblastoma.
New Partnership to Provide Bioanalytical and DMPK ServicesNews
Concept Life Sciences, the integrated drug discovery, development and analytical services company, and Alderley Analytical, bioanalytical Contract Research Organisation (CRO), today announced they have signed a partnership agreement to provide high-value bioanalytical and DMPK study services.