Medarex Reports Phase 1 Clinical Data of MDX-1100 at Digestive Disease Week
Wednesday May 21, 8:00 am ET
Data Supportive of Phase 2 Clinical Development Program Currently Underway
PRINCETON, N.J., May 21 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today positive safety data from two Phase 1 trials that support the Phase 2 clinical development program of MDX-1100, a fully human monoclonal antibody that targets CXCL10 (also known as IP-10), for the treatment of inflammatory diseases. MDX-1100 could potentially treat diseases such as ulcerative colitis (UC) and rheumatoid arthritis (RA) by suppressing the inflammatory process characteristic of these diseases. Results from the Phase 1 trials were presented at the Digestive Disease Week (DDW), being held May 17-22, 2008 in San Diego. (Abstracts #704, #T1145 and #W1170)
A Phase 1 open-label pilot study was conducted to evaluate the safety (primary endpoint) and preliminary efficacy of escalating single doses of MDX-1100 in 11 patients with moderate to severe UC. This study demonstrated that single doses (ranging from 0.3 to 10.0 mg/kg) of MDX-1100 in patients with active UC were safe and well-tolerated. Four patients in the study had protocol-defined clinical responses, determined by the Ulcerative Colitis Disease Activity Index (UCDAI) which scores the frequency and the amount of bloody stool per day that is recorded in a patient diary, physician global assessment and the assessment of colon mucosal inflammation ascertained by endoscopy. None of the three serious adverse events reported in the study were considered drug related. (Abstract #704)
A separate Phase 1 double-blind, placebo-controlled study was conducted to determine safety and pharmacokinetics of escalating single doses (ranging from 0.01 to 10 mg/kg) of MDX-1100 in 50 healthy volunteers. MDX-1100 demonstrated dose-proportional pharmacokinetics, and a potential pharmacodynamic effect that signaled a decrease in the production of CXCL10 was observed at 10 mg/kg. There were no infusion reactions, and the drug was non-immunogenic. No serious adverse effects were observed in this study. The most common drug related adverse events were drowsiness, cough and shortness of breath. (Abstract #T1145)
"The safety and preliminary efficacy data from these Phase 1 studies provide the foundation for our recently initiated Phase 2 program with MDX- 1100," said Geoffrey M. Nichol, Senior Vice President, Product Development of Medarex. "We are excited with the Phase 2 program and look forward to the outcome of the proof-of-concept studies in ulcerative colitis and rheumatoid arthritis."
Additional studies presented at DDW demonstrated that CXCL10 induced expression of several pro-inflammatory molecules and that these CXCL10 inducible genes were upregulated in patients with ulcerative colitis. (Abstract #W1170)
About MDX-1100
MDX-1100 is a fully human antibody that targets CXCL10 (also known as IP-10), a chemokine expressed in association with multiple inflammatory disease indications such as rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis. Published data suggests that CXCL10 plays key roles in murine models of inflammatory bowel disease (IBD) and RA. Moreover, CXCL10 levels are increased in patients with these diseases. Phase 2 proof-of-concept clinical trials of MDX-1100 in ulcerative colitis and rheumatoid arthritis have been initiated. |
