Medarex Proceeding to Phase III in Rheumatoid Arthritis (MEDX)

May 14, 2009 · Filed Under General 

Medarex, Inc. (Nasdaq: MEDX) has yet to show any significant indications in either direct before 8:00 AM EST this morning, but the company announced that its MDX-1100 Phase 2 ‘proof of concept’ trial in patients with active rheumatoid arthritis met its primary endpoints for patients receiving methotrexate.

The top-line results are from a 70-patient multi-center, randomized, double-blind, placebo-controlled Phase 2 trial.  The trial indicated that three-times the number of patients treated with 10 mg/kg of MDX-1100 every two weeks achieved at least a 20% improvement in RA signs and symptoms at 12 weeks when compared to placebo.

These results were statistically significant when compared with placebo (p=0.0024). The antibody combination with methotrexate was generally safe and well-tolerated. Full results from this Phase 2 trial are planned to be presented at a future scientific meeting.

The company believes it may be able to offer a potentially important and novel treatment option for rheumatoid arthritis and potentially other inflammatory indications.  It is now actively preparing for the next stage of clinical development for MDX-1100 in RA and will explore the broader potential of MDX-1100 in a range of inflammatory diseases, including ulcerative colitis in an ongoing companion Phase 2 study.

MDX-1100 is a fully human antibody that targets IP-10 (also known as CXCL-10).  While Medarex is partners with many companies, the MDX-1100 product candidate is a wholly-owned Medarex asset and appears to not be tied to other drug or biotech firms.

Medarex also noted a figure from the American College of Rheumatology showing that some 1.3 million adult Americans have rheumatoid arthritis.

JON C. OGG

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