Millennium Resumes Antibody Program

Millennium Pharmaceuticals has initiated 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.

The new program includes 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 positive results from a Phase II trial involving 181 ulcerative colitis patients that showed MLN0002 was well tolerated and achieved a statistically significant improvement in clinical remission.

“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.”