Millennium Initiates New Clinical Program For Ulcerative Colitis Candidate
This article was originally published in The Pink Sheet Daily
Executive Summary
Program includes Phase II dose-ranging study and Phase I study in healthy volunteers.
|
Millennium Pharmaceuticals has initiated two new clinical studies of its monoclonal antibody MLN0002, derived from a newly engineered, commercially scaleable cell line, the company announced May 18. The clinical program includes a Phase II dose-ranging trial in ulcerative colitis patients and Phase I study in healthy volunteers, the Cambridge, Mass., firm noted. The studies follow positive results from a randomized Phase II trial of MLN0002, derived from an earlier cell line, in ulcerative colitis patients. In that trial, the antibody was "well tolerated and achieved a statistically significant improvement in clinical remission, the trial's primary endpoint, compared to placebo," Millennium said. "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," Millennium Chief Medical Officer Nancy Simonian stated in a news release. [Editor's note: Simonian sat down with "The Pink Sheet" DAILY in February to discuss MLN0002, as well as Millennium's oncology pipeline (1 (Also see "Millennium Chief Medical Officer Nancy Simonian: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 16 Feb, 2007.)).] Pending the outcomes of the current trials, MLN0002 could enter pivotal trials in 2008, Millennium said. MLN0002 binds to the T-cell integrin alpha 4 beta 7 and is potentially applicable to a variety of gastrointestinal diseases, including ulcerative colitis, according to the firm. Millennium also recently reported that it has discovered biomarkers for multiple myeloma therapy Velcade . Also on May 18, Johnson & Johnson's liposomal doxorubicin product Doxil cleared FDA for use in combination with Velcade in the multiple myeloma setting (2 (Also see "J&J’s Doxil Approved For Use With Velcade In Second-Line Multiple Myeloma" - Pink Sheet, 18 May, 2007.)). - Brooke McManus ([email protected]) |