News and Events 
THERAPEUTIC APPROACH DEVELOPED BY CSC SCIENTIFIC ADVISORY BOARD MEMBERS ENTERS PHASE 2 CLINICAL TRIALS
Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis
Princeton, NJ - May 12, 2008
Medarex, Inc. (Nasdaq: MEDX)
announced today that it has initiated the Phase 2 clinical development program of
MDX-1100, a fully human monoclonal antibody that targets CXCL10 (also known as
IP-10), in ulcerative colitis (UC) and rheumatoid arthritis (RA). MDX-1100 could
potentially treat UC and RA by suppressing the inflammatory process characteristic
of these diseases.
"Based on positive safety data in Phase 1 studies, we have initiated patient
enrollment in Phase 2 studies that are designed to establish proof-of-concept," said
Geoffrey M. Nichol, M.B.Ch.B., Senior Vice President of Product Development at
Medarex. "We are optimistic about the broad potential of MDX-1100 to address a
range of inflammatory diseases."
Patients in the Phase 2 randomized, double-blind, placebo-controlled,
multi-center study in UC will be administered MDX-1100 at 10 mg/kg or placebo every
2 weeks for a total of 4 doses. All patients will have active UC and will continue
standard UC therapy during the trial. The trial is expected to enroll 106 patients
at multiple sites internationally. The primary endpoint of the study is the
response rate at 8 weeks. Clinical response is based on the Mayo score, a composite
endpoint that assesses stool frequency and the amount of bloody stool per day as
recorded in a patient diary, physician global assessment and the assessment of colon
mucosal inflammation ascertained by endoscopy.
Patients in the Phase 2 randomized, double-blind, placebo-controlled,
multi-center study in RA will be administered MDX-1100 at 10 mg/kg or placebo every
2 weeks for a total of 6 doses. All patients will have active RA while on
methotrexate. The trial is expected to enroll 70 patients at multiple sites in
Europe. The primary endpoint of the study is the ACR20 response, a composite
endpoint that indicates a 20% improvement in RA signs and symptoms, at 12 weeks.
Medarex also announced that results from the MDX-1100 Phase 1 trials will be
presented at the Digestive Disease Week (DDW) meeting, being held May 17 - 22, 2008
in San Diego. The following abstracts are expected to be the subject of
presentations at the DDW 2008 conference:
- "A Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and
Pharmacokinetic Study of MDX-1100, a Fully Human Anti-CXCL10 Monoclonal
Antibody, in Healthy Subjects" (Abstract #T1145) - Poster presentation
on May 20, 2008 from 12:00 to 2:00 PM CDT.
- "A Phase 1 Open-Label, Single-Dose, Dose-Escalation Study of MDX-1100,
a High-Affinity, Neutralizing, Fully Human IgG1k Anti-CXCL10 (IP10)
Monoclonal Antibody, in Ulcerative Colitis" (Abstract #704) - Oral
presentation on May 20, 2008 from 3:00 to 3:15 PM CDT.
- "CXCL10 Expression and Biological Activities in Inflammatory Bowel
Disease" (Abstract #W1170) - Poster presentation on May 21, 2008 from
12:00 to 2:00 PM CDT.
These presentations support the development of MDX-1100 for the treatment of
inflammatory diseases such as ulcerative colitis and rheumatoid arthritis.
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. It was developed by CSC Scientific Advisory Board members Hans Keirstead and Tom Lane.
