A Journey from Early Trials to Dosing the First Phase III Patient
The GEMINI™ studies are investigating the drug vedolizumab (ve-do-liz-u-mab), also known as MLN0002, in the primary types of inflammatory bowel disease (IBD) -- ulcerative colitis (UC) and Crohn's disease (CD). UC and CD are chronic, relapsing-remitting inflammatory diseases and are debilitating, challenging to treat, and increasing in incidence worldwide. Together, they affect more than a million people in the United States and millions worldwide.
"Even though our company recently became solely focused in the research and treatment of cancer, given the exceptional importance and scope of this Phase III trial, in cooperation with our parent company, Takeda Pharmaceuticals Limited, we elected to continue the operation of the MLN0002 study from within the Millennium clinical development environment," said team leader Veit Schmelmer. "If approved by the regulatory authorities, commercialization of vedolizumab will become the responsibility of Takeda."
The Vedolizumab Story:
- » Takeda Pharmaceutical Company Limited, Millennium's parent company, announced early in 2009 that the first patient had entered Phase III clinical studies.
- » The Phase III program, named GEMINI™, will enroll nearly 2,000 patients at more than 500 sites on a global basis.
- » GEMINI consists of three separate studies – a placebo-controlled induction and maintenance study in patients with UC, a placebo-controlled induction and maintenance study in patients with CD, and an open-label long- term safety study in patients with either UC or CD.
Vedolizumab Milestones
Evolution of Vedolizumab* |
| 1998 - 2003 |
Early clinical trials |
| 2004 |
Phase II proof of concept established in UC and CD |
| 2005 |
Phase II ulcerative colitis induction study data published, New England Journal of Medicine |
| 2008 |
Phase II Crohn's disease induction study data published, Clinical Gastroenterology & Hepatology |
The goals of the GEMINI program are to investigate:
- » Vedolizumab’s effect on clinical response and remission in moderately to severely active IBD (CD and UC) patients, who have failed at least one conventional therapy
- » Vedolizumab's effect on mucosal healing in UC
- » Long-term safety of Vedolizumab
The GEMINI trials have advanced to Phase III based on the results of two randomized Phase II trials, one in UC published in 2005 in the New England Journal of Medicine and the other in CD published in Clinical Gastroenterology & Hepatology in 2008.
IBD may be associated with such classic symptoms of the diseases as crampy abdominal pain, persistent diarrhea, incontinence, rectal bleeding, fever, malaise and weight loss. Vedolizumab is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin (Soler et al., 2009)1, a key mediator of inflammation in the gastrointestinal tract.
* Vedolizumab also was known as LDP02, MLN02 or MLN0002 during development.
Clinical Trial Enrollment
For information about enrolling patients in Millennium-sponsored clinical trials of investigational and marketed oncology drugs, please call 877 MPI Drug [(+1) 877-674-3784] or email Medical@mlnm.com.
Millennium notifies the public of the start of all Company-sponsored Phase I, II, III and IV clinical trials designed to test the safety or efficacy, or both of Millennium investigational and marketed oncology drugs on www.clinicaltrials.gov, a National Institute of Health registry (a list) of ongoing clinical trials. This notification reflects the Company's commitment to provide patients and physicians with a list of ongoing clinical trials.
1Soler, D., Chapman, T., Yang, L.L., Wyant, T., Egan, R. & Fedyk, E.R. 2009. The Binding Specificity and Selective Antagonism of Vedolizumab, an Anti-47 Integrin Therapeutic Antibody in Development for Inflammatory Bowel Diseases. J Pharmacol. Exp. Therapeutics. 330(3):864-875.
