>NEWSROOM >Press Releases >2011 >Anti-Cancer Agent AMG 386 Enters into Phase III Clinical Tri...

Anti-Cancer Agent AMG 386 Enters into Phase III Clinical Trials in Japan

Osaka, Japan, CAMBRIDGE, Mass. and Tokyo, Japan, January 24, 2011 – Takeda Pharmaceutical Company Limited (“Takeda”), Millennium: The Takeda Oncology Company and Takeda Bio Development Center Limited (“Takeda Bio”) today announced that Takeda and Millennium reached a decision to participate in the TRINOVA-1 Phase III clinical trial on anti-cancer agent AMG 386. The TRINOVA-1 trial is being conducted by Amgen, Inc. ("Amgen") globally, and based on the decision, Takeda Bio has initiated the Japanese portion of the trial and will lead the molecule’s ongoing development in Japan.

AMG 386 is an anti-angiopioetin peptibody*1 discovered by Amgen. AMG 386 targets the angiopoietin axis by blocking the interactions between angiopoietins -1 and -2 (Ang1 and Ang2) and their receptor Tie2. Ang1 and Ang2, types of cytokines*2, each play a significant role in the growth and stabilization of neovascular vessels. Angiogenesis, the formation of neovascular vessels, is necessary for tumor growth and metastasis. By inhibiting Ang1 and Ang2 from binding to Tie2 receptors, AMG 386 ultimately produces anti-tumor effects.

TRINOVA-1, currently enrolling, is a global multicenter, randomized, double-blind trial of paclitaxel plus AMG 386 or placebo in women with recurrent ovarian cancer. The primary endpoint is progression-free survival. The trial was commenced following the presentation of promising Phase II data in ASCO and ESMO last year.

“Advancement to Phase III clinical trials is a huge step forward in the development of AMG 386,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “These patients have very limited treatment options and we are excited by the potential of this compound to alleviate this need in ovarian cancer.”

"We believe that this agent with a new mechanism of action will benefit women with recurrent ovarian cancer for which very few treatments are currently available,” said Hiroyasu Nakamura, President of Takeda Bio. “We will accelerate our development program to make it clinically available and help them as early as possible."

*1 Peptibody:
A recombinant peptide-Fc fusion protein; A peptide consists of two or more amino acids with smaller molecular weight and simpler structure than protein. Fc is a constant region of heavy chain of human immunoglobulin; a peptibody has characteristics of both peptide and antibody.

*2 Cytokine:
A general term for low-molecular hormone-like proteins that are secreted from cells of various immune systems and are responsible primarily for regulation of the strength and duration of immune reactions.


About Takeda

Located in Osaka, Japan, Takeda 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 strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the US, and has a robust clinical development pipeline of global product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its respective websites, www.millennium.com.

About Takeda Bio

Located in Tokyo, Japan, Takeda Bio Development Center Limited, a wholly owned subsidiary of Takeda, plays a central role in clinical development of Takeda’s oncology products in Japan. http://www.takeda.co.jp/tbdc/ (Japanese page only)


# # #

Latest Press Releases