Mederex initiates ulcerative colitis phase I trial
its human monoclonal antibody for the treatment of ulcerative
colitis after the FDA granted the company an Investigational New
Drug (IND) application.
MDX-1100, a fully human monoclonal antibody targets IP-10 (also known as CXCL10), for the treatment of ulcerative colitis. IP-10 is a chemokine that that is associated with the pathogenesis of multiple inflammatory diseases, including ulcerative colitis.
MDX-1100 is a fully human antibody that is designed to target IP-10 (also known as CXCL10), a chemokine involved in the migration of activated T cells and monocytes into sites of inflammation and associated with multiple autoimmune disorders and inflammatory diseases such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease.
Preclinical studies demonstrate that antibodies targeting IP-10 neutralize the effects of IP-10 and attenuate disease progression in animal models of ulcerative colitis and inflammatory bowel disease, as well as multiple sclerosis and rheumatoid arthritis.
The multi-centre, single-dose, dose-escalation Phase I clinical trial is expected to enrol up to 32 patients with ulcerative colitis. The trial is designed to collect safety and initial efficacy data. Subject to patient enrolment, data from the Phase I clinical trial is expected in the second half of 2006.
Donald Drakeman, president and CEO of Medarex said: "We believe that by targeting IP-10, MDX-1100 has the broad potential to address multiple autoimmune and inflammatory diseases."
Ulcerative colitis (UC) is a chronic inflammatory bowel disease of the colon and is characterized by inflammation and ulceration of the colon's innermost lining. Symptoms typically include bloody diarrhoea and abdominal pain.
According to the Crohn's & Colitis Foundation of America, it is estimated that there are up to approximately 500,000 Americans with ulcerative colitis.
Research and Markets estimates the therapeutics market for IBD - Crohn's disease and ulcerative colitis - worldwide will reach $1.88 billion (€849.6 million) in 2004 (estimated) and will reach $2.88 billion worldwide in 2009, representing a compound annual growth rate of 8.9 per cent.
