Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Medarex has received clearance from the FDA to initiate a phase I clinical trial for MDX-1100, a fully human monoclonal antibody intended for the treatment of ulcerative colitis.
Subscribe to our email newsletter
MDX-1100 targets IP-10 (also known as CXCL10), a chemokine associated with the pathogenesis of multiple inflammatory diseases, including ulcerative colitis. 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-center, single-dose, dose-escalation phase I clinical trial is expected to enroll up to 32 patients with ulcerative colitis. The trial is designed to collect safety and initial efficacy data and, subject to patient enrollment, data from the trial is expected in the second half of 2006.
“We are pleased to see MDX-1100, the 23 UltiMAb-derived antibody product candidate, enter into the clinic,” said Donald Drakeman, president and CEO of Medarex. “We believe that by targeting IP-10, MDX-1100 has the broad potential to address multiple autoimmune and inflammatory diseases.”