Athersys, Inc. announced the initiation of patient enrollment, and dosing of the first patient for a phase II clinical trial evaluating the safety and efficacy of administration of MultiStem, Athersys' allogeneic cell therapy product for the treatment of Ulcerative Colitis (UC). This phase II clinical trial is part of a strategic global collaboration between Athersys and Pfizer Inc. to investigate MultiStem for the treatment of Inflammatory Bowel Disease (IBD).

The phase II study is a randomized, double-blind, placebo-controlled, multi-centre study designed to investigate the safety and efficacy of MultiStem in subjects with moderate to severe UC. The trial will be conducted at multiple clinical sites in North America and Europe, and is expected to include up to approximately 126 patients. Individuals participating in the study will receive multiple doses of either MultiStem or placebo, administered over a period of several weeks. Primary safety and efficacy endpoints will include endoscopic evaluation at baseline and at eight weeks, with a follow-up of all patients through twelve months.

“Despite treatment advances in recent years, Inflammatory Bowel Disease remains a debilitating condition for many individuals, and represents an area of substantial unmet medical need,” said Gil Van Bokkelen, PhD, chairman and chief executive officer of Athersys. “We're pleased with the continued progress of our partnership with Pfizer and excited about commencing the trial.”

Dr Ruth McKernan, Head of Pfizer Regenerative Medicine, added: “Both teams have worked very well together, and we are pleased to be commencing this phase II trial in this innovative area.”

According to Datamonitor, more than two million individuals in the United States, core European markets and Japan suffer from various forms of IBD, including Crohn's Disease and UC, which is the most commonly diagnosed form of IBD. UC is a chronic, relapsing inflammatory condition involving all or a portion of the colon. Patients with UC most commonly present with diarrhoea, urgency, rectal bleeding, and abdominal pain. Patients may also experience fatigue, fevers, weight loss, and dehydration. The symptoms can be incapacitating.

MultiStem is a patented and proprietary product candidate that can be manufactured on a large scale, subsequently frozen and later thawed and administered, similar to traditional biologics. It consists of a clinical grade preparation of non-embryonic stem cells obtained from bone marrow that have the potential to produce a range of factors and form multiple cell types.

MultiStem appears to work through several mechanisms, but a primary mechanism appears to be the production of therapeutic proteins and other molecules produced in response to inflammation and tissue damage.

Athersys is a clinical stage biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life and is developing MultiStem, a patented, adult-derived “off-the-shelf” stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation and oncology treatment support, ischemic stroke, and inflammatory bowel disease.