Millennium Resumes Clinical Program for MLN0002
Thursday May 17, 8:01 am ET
-Novel Product Candidate in Ulcerative Colitis on Track for Pivotal Trial in 2008-
CAMBRIDGE, Mass., May 17 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) 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. |
