Healthcare Industry News:  Millennium 

Biopharmaceuticals Oncology

 News Release - July 28, 2008

Millennium Advances Oncology Pipeline

Company initiates trial of first-in-class oncology molecule and progresses Aurora A kinase program

CAMBRIDGE, Mass., July 28 (HSMN NewsFeed) -- Millennium: The Takeda Oncology Company today announced the initiation of a Phase I trial series of MLN4924, the Company's first-in-class, small molecule inhibitor of the Millennium-discovered target, the Nedd 8 Activating Enzyme (NAE). 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.

In addition, the Company initiated a Phase I hematologic trial of MLN8237, the first-in-class, 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 (ALL). Additional data related to the Aurora A kinase development program are scheduled to be presented at the 20th EORTC-NCI-AACR Symposium in Geneva, Switzerland in October, 2008. 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., Chief Medical Officer, Millennium. "The emerging data associated with MLN4924 and MLN8237 support our vision of solidifying Takeda as a leader in oncology discovery and development by 2020."

Industry Leadership

In addition to the significant clinical development progress, Joseph B. Bolen, Ph.D., Chief Scientific Officer, Millennium, will chair the Focus on Cancer track at IBC Life Sciences Drug Discovery & Development of Innovative Therapeutics Conference and Exhibition. The event will take place August 4-7, 2008 at the World Trade Center Boston & Seaport Hotel in Boston. The cancer track presentations will focus on therapies for Hematology, Lung Cancer, Blood Borne Cancers, and Clinical Biomarkers.

About MLN4924

MLN4924 targets NAE, a novel, Millennium-discovered target in the ubiquitin proteasome pathway (UPP). NAE controls a subset of proteins in the UPP that regulate cancer cell survival.

About MLN8237

MLN8237 is a second-generation small molecule backup of MLN8054, the Company's first Aurora A kinase inhibitor. Both molecules were discovered and developed by scientists at Millennium for the treatment of cancer. The Aurora A kinase is required for cells to proceed through mitosis (cell division) and therefore, represents an attractive oncology therapeutic target.

About Millennium

Millennium: The Takeda Oncology Company, and a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium research, development and commercialization activities are focused in oncology. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. Additional information about Millennium is available through its website, http://www.Millennium.com.


Source: Millennium

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