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THERAPEUTIC APPROACH DEVELOPED BY CSC SCIENTIFIC ADVISORY BOARD MEMBERS ACHEIVES PRIMARY ENDPOINT IN PHASE 2 TRIAL FOR RHEUMATOID ARTHRITIS
Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis
PRINCETON, N.J., May 14, 2009
Medarex, Inc. (Nasdaq: MEDX) today announced that the MDX-1100 Phase 2 proof-of-concept trial in patients with active rheumatoid arthritis (RA) receiving methotrexate successfully met its primary endpoint. The top-line results from the recently completed 70-patient multi-center, randomized, double-blind, placebo-controlled Phase 2 trial indicated that when compared to placebo, 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, the primary endpoint of the study, as measured by the American College of Rheumatology (ACR). 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 will be presented at a future scientific meeting.
"We are greatly encouraged by this demonstration of efficacy from a well-designed and well-executed study," said Howard H. Pien, Chairman and CEO of Medarex. "These results show that by targeting the chemokine IP-10 with our MDX-1100 antibody, we may be able to offer a potentially important and novel treatment option for rheumatoid arthritis and potentially other inflammatory indications."
"It is exciting to see our concept become reality, and better the lives of humans" said Hans S. Keirstead of California Stem Cell. "It's why we do what we do."
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. Ability Biomedical Corporation, which licensed the discoveries made by California Stem Cell Scientific Advisory Board members Hans Keirstead and Tom Lane at the University of California at Irvine, developed the technology.
Ability Biomedical Corporation was founded in 2002 by Hans Keirstead with financing from GrowthWorks Capital Ltd. Keirstead served as CEO of the company and negotiated its acquisition by Medarex, Inc. in 2004, yielding a 4x return to investors in just two years.
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