Millennium Announces Phase I Trial Of MLN0415 For Inflammatory Disorders

Main Category: Arthritis / Rheumatology
Also Included In: Multiple Sclerosis;  Clinical Trials / Drug Trials
Article Date: 31 Aug 2006 - 0:00 PDT

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Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the initiation of a Phase I study of MLN0415, an oral, highly selective, small molecule inhibitor of IKK2, which targets a major inflammatory pathway. The randomized, double-blind, placebo-controlled study will enroll up to 72 healthy volunteers and assess safety, tolerability, pharmacokinetic and pharmacodynamic effects. MLN0415 has a unique mechanism of action that has the potential to address multiple inflammatory disorders including rheumatoid arthritis and multiple sclerosis.

"MLN0415, a new molecule discovered by Millennium scientists, selectively targets a key pathway involved in inflammatory response, which makes it an attractive product candidate for preventing or delaying disease progression," said Nancy Simonian, M.D., Senior Vice President, Clinical, Medical and Regulatory Affairs, Millennium. "We continue to advance novel molecules into the clinic and this study is part of a larger inflammatory development program that includes five product candidates."

About MLN0415

MLN0415 is a novel, small molecule IKK2 inhibitor, discovered by Millennium scientists. In preclinical studies, MLN0415 was shown to decrease NF-kB activation and down-regulate the expression of a number of inflammatory proteins. Because inflammatory proteins play a critical role in inflammation and drive the inflammatory response to disease, controlling these proteins may prevent or slow disease progression.

The Millennium-sanofi-aventis Collaboration

Millennium and sanofi-aventis have an alliance focused on developing and commercializing small molecule drugs for the treatment of inflammatory diseases such as rheumatoid arthritis and multiple sclerosis. MLN0415 is one of several small molecules that are part of this collaboration, three of which are in the clinic.

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical Company based in Cambridge, Mass., markets VELCADE(R) (bortezomib) for Injection, a novel cancer product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. 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. The Company's website is http://www.millennium.com.

This press release contains "forward-looking statements," including statements about the Company's growth and development of products. Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in its drug discovery and clinical development programs; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; the Company's dependence upon strategic alliance partners to develop and commercialize products and services based on its work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from its development efforts; product withdrawals; competitive factors; difficulties or delays in manufacturing the Company's products; government and third-party reimbursement rates; the commercial success of VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue consistent with internal forecasts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties the Company faces, see the reports it has filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward- looking statements, whether as a result of new information, future events or otherwise.

Millennium Pharmaceuticals, Inc.
http://www.millennium.com

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