Phase I Trial Of MLN0415 For Inflammatory Disorders

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Millennium Announces Phase I Trial Of MLN0415 For Inflammatory Disorders

Article Date: 31 Aug 2006 - 0:00am (PDT)

http://www.medicalnewstoday.com/medicalnews.php?newsid=50868 & nfid=nl

Millennium Pharmaceuticals, Inc. 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 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® (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.