Millennium Initiates Two Phase II Trials Of Novel Aurora A Kinase Inhibitor

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials
Article Date: 04 Mar 2009 - 3:00 PDT

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Takeda Pharmaceutical Company Limited (TSE:4502) and its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc., announced today 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.

About MLN8237

MLN8237 is an oral, investigational drug, which has been shown in preclinical studies to inhibit Aurora A kinase. The compound was discovered by Millennium scientists. The Aurora A kinase is required for cells to proceed through mitosis (cell division) and therefore, represents an attractive target to investigate in oncology. MLN8237 is the first drug candidate in the Company's cell cycle inhibition program to enter Phase II clinical investigation.

About Takeda

Located in Osaka, Japan, Takeda Pharmaceutical Company Limited (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. ("Takeda", TSE: 4502) in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, http://www.millennium.com

Editors' Note: This press release is also available under the Media section of the Company's website at: http://www.millennium.com.

Millennium

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