Inflammatory Bowel Disease (IBD) is a group of inflammatory and autoimmune conditions that affect the colon and small intestine, typically resulting in severe abdominal pain, weight loss, vomiting and diarrhea. The most common forms of the disease are ulcerative colitis and Crohn’s disease, which are estimated to affect more than 2.3 million people in the United States, five major European markets (United Kingdom, Germany, France, Italy and Spain) and Japan.
There are a variety of therapies currently available for patients that suffer from IBD, including agents such as prednisolone, mesalazine, corticosteroids, and the more recently developed anti-TNFα therapies. Unfortunately, for many patients these agents are only effective transiently, while in some patients they fail to work at all. Chronic IBD can be a severely debilitating condition, and advanced cases may require surgery to remove the affected region of the bowel, and may also require temporary or permanent colostomy or iliostomy. In many cases, surgery does not achieve a permanent cure, and patients suffer a return of the disease.
In December 2009, we entered into a collaboration agreement with Pfizer to develop and commercialize MutiStem® for the treatment of IBD for the worldwide market. In the first quarter of 2011 we initiated a Phase 2 clinical trial involving administration of MultiStem for the treatment of ulcerative colitis, the most common form of IBD. We selected this as our initial clinical target in the IBD area, because the underlying disease tends to be more homogeneous than for Crohn’s disease, and it allows for endoscopic evaluation to determine whether or not the lesions in the colon are healing and the patient is improving.
The Phase 2 study is being conducted at multiple clinical centers in the United States and Europe, and is a randomized, double blind, placebo controlled study that will involve approximately 126 patients. In the study, subjects will undergo baseline endoscopic evaluation and then receive treatment with either MultiStem or placebo, and be evaluated over several months. After eight weeks, there is a second endoscopic evaluation, followed by clinical assessment at 16 weeks, and patient follow-up for 12 months. Following completion of patient enrollment and completion of the final clinical assessment, we intend to announce interim results from the study.