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Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis
PRINCETON, N.J., May 14 /PRNewswire-FirstCall/ -- 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)
20 measurement of response. 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.
"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."
"Based on these positive results with a novel pro-inflammatory target, we are
actively preparing for the next stage of clinical development for MDX-1100 in RA,
including the potential for subcutaneous dosing," said Geoffrey M. Nichol, M.B.Ch.B., Senior
Vice President of Product Development at Medarex. "We also look forward to exploring
the broader potential of MDX-1100 in a range of inflammatory diseases, including
ulcerative colitis in an ongoing companion Phase 2 study."
About MDX-1100 in Rheumatoid Arthritis
MDX-1100 is a fully human antibody that targets IP-10 (also known as CXCL-10), a
chemokine expressed in association with multiple inflammatory disease indications.
The MDX-1100 Phase 2 study in RA enrolled 70 patients with active disease while on
methotrexate. Patients in the study were randomized to receive either placebo or MDX-1100
(10 mg/kg) every two weeks for a total of six doses. The primary endpoint of the study
was ACR20 response at 12 weeks. Secondary endpoints included other clinical response
assessments, pharmacokinetics of MDX-1100, and potential biomarkers of activity.
According to the American College of Rheumatology, 1.3 million adult Americans
have been diagnosed with rheumatoid arthritis, a chronic autoimmune disease that
develops when certain cells of the immune system inappropriately attack healthy joint
tissue, thereby causing swelling, inflammation and damage of joints, as well as systemic
inflammation and damage of other tissues.
About MDX-1100 in Other Indications
MDX-1100 is also being explored as a treatment for ulcerative colitis (UC). A
Phase 2 randomized, double-blind, placebo-controlled study in patients with active UC
Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis
PRINCETON, N.J., May 14 /PRNewswire-FirstCall/ -- 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)
20 measurement of response. 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.
"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."
"Based on these positive results with a novel pro-inflammatory target, we are
actively preparing for the next stage of clinical development for MDX-1100 in RA,
including the potential for subcutaneous dosing," said Geoffrey M. Nichol, M.B.Ch.B., Senior
Vice President of Product Development at Medarex. "We also look forward to exploring
the broader potential of MDX-1100 in a range of inflammatory diseases, including
ulcerative colitis in an ongoing companion Phase 2 study."
About MDX-1100 in Rheumatoid Arthritis
MDX-1100 is a fully human antibody that targets IP-10 (also known as CXCL-10), a
chemokine expressed in association with multiple inflammatory disease indications.
The MDX-1100 Phase 2 study in RA enrolled 70 patients with active disease while on
methotrexate. Patients in the study were randomized to receive either placebo or MDX-1100
(10 mg/kg) every two weeks for a total of six doses. The primary endpoint of the study
was ACR20 response at 12 weeks. Secondary endpoints included other clinical response
assessments, pharmacokinetics of MDX-1100, and potential biomarkers of activity.
According to the American College of Rheumatology, 1.3 million adult Americans
have been diagnosed with rheumatoid arthritis, a chronic autoimmune disease that
develops when certain cells of the immune system inappropriately attack healthy joint
tissue, thereby causing swelling, inflammation and damage of joints, as well as systemic
inflammation and damage of other tissues.
About MDX-1100 in Other Indications
MDX-1100 is also being explored as a treatment for ulcerative colitis (UC). A
Phase 2 randomized, double-blind, placebo-controlled study in patients with active UC
