Millennium Resumes Clinical Program For MLN0002

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Irritable-Bowel Syndrome;  Crohn's;  Clinical Trials / Drug Trials
Article Date: 18 May 2007 - 0:00 PDT

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Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the initiation of patient dosing in a clinical program designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MLN0002 derived from a newly engineered, commercially scaleable cell line. MLN0002 is a novel monoclonal antibody that binds to the T-cell integrin alpha 4 beta 7 with potential in a variety of gastrointestinal diseases, including ulcerative colitis.

"MLN0002 is differentiated by its unique mechanism of action that selectively inhibits trafficking of inflammatory cells to the gastrointestinal tract. This innovative approach has the potential to increase the level of efficacy and reduce the risk of unwanted side effects seen with currently available therapies," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The return of MLN0002 to clinical trials is exciting for Millennium and ulcerative colitis patients. MLN0002 is one of only a few novel product candidates being investigated as alternatives to anti-TNF and other immunosuppressive therapies for ulcerative colitis and potentially other inflammatory bowel diseases."

"There is clearly a need for new therapeutic options as a substantial percentage of ulcerative colitis patients either do not respond to current therapies or have concerns regarding the safety of these therapies," said Brian Feagan, M.D., Professor of Medicine at the University of Western Ontario, London, Canada and a leading expert in inflammatory bowel disease. "Based on the positive experience of patients in the previous Phase II trial, we are enthusiastic about moving this novel product candidate forward in the hopes of delivering a new and effective option to patients for whom ulcerative colitis remains inadequately managed."

The new clinical program for MLN0002 consists of two studies: a Phase II dose-ranging trial in ulcerative colitis patients and Phase I study in normal healthy volunteers. These studies were initiated following favorable results from a previous randomized Phase II trial involving 181 ulcerative colitis patients. In that trial, MLN0002, derived from an earlier cell line, was well tolerated and achieved a statistically significant improvement in clinical remission, the trial's primary endpoint, compared to placebo. Serious adverse events were mainly related to exacerbations of underlying ulcerative colitis, which occurred in 15 percent of patients in the treatment groups, compared to 10 percent in the placebo group. The results of this trial were published in the June 16, 2005 issue of the New England Journal of Medicine.

About MLN0002

MLN0002 is a novel monoclonal antibody that selectively binds to alpha 4 beta 7, a T-cell integrin. Its mechanism of action inhibits the migration of T-cells specifically to the gastrointestinal tract, as demonstrated in non- clinical studies. Increased gut T-cell trafficking is believed to play a role in the pathogenesis of inflammatory bowel diseases (IBD), including conditions such as ulcerative colitis and Crohn's disease.

MLN0002 is part of a robust pipeline and a component of Millennium's 2007 goals of accelerating several key assets.

About ulcerative colitis

Ulcerative colitis is an IBD, the general name for a group of chronic disorders that cause inflammation in the gastrointestinal tract. The disease can be difficult to diagnose because its symptoms are similar to other intestinal disorders and to another type of IBD called Crohn's disease.

Ulcerative colitis causes inflammation and sores, called ulcers, in the lining of the rectum and colon or large intestine. Inflammation in the colon also causes the colon to empty frequently, causing diarrhea. Other typical symptoms include lower abdominal pain, rectal irritability and fecal incontinence.

Annually, ulcerative colitis develops in approximately 24,300 patients in the U.S. The prevalence in the U.S. is 671,000. Ulcerative colitis can occur in people of any age, but it usually starts between the ages of 15 and 30, and less frequently between 50 and 70 years of age. It affects men and women equally and appears to run in families, with reports of up to 20 percent of people with ulcerative colitis having a family member or relative with ulcerative colitis or Crohn's disease. A higher incidence of ulcerative colitis is seen in Caucasians and people of Jewish descent.

About Millennium

Millennium Pharmaceuticals, Inc., 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'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. Millennium'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