Press Center » Archived News Releases » 2001
Initial Results Presented At ACR Meeting
San Francisco, CA - November 12, 2001 - Genmab A/S (CSE: GEN
and Neuer Markt: GE9D) announced today that HuMax-CD4 has shown a
statistically significant dose response in doses up to 160mg in initial
results of a psoriasis Phase II dose finding study. In addition, mean
Psoriasis Area Severity Index (PASI) score was reduced in all treatment
groups with a 30% difference between the placebo and 160mg dose groups.
HuMax-CD4 was also safe and well tolerated. These initial results are based
on data at the seven-week timepoint from 79 of 85 patients in the Phase II
study and are being presented today by Genmab's Chief Scientific Officer
Jan van de Winkel, Ph.D. at the 65th Annual Meeting of the American College
of Rheumatology in San Francisco, California.
This psoriasis trial is a small placebo controlled Phase II study designed to
establish the safety and lowest effective dose of HuMax-CD4 in patients with
moderate to severe psoriasis. Patients received either one of four dose
levels or placebo once weekly for four weeks. They are being followed for a
total of 16 weeks, and final results of the study will not be available until
next year.
The dose response observed here correlates with the results of the HuMax-CD4
Phase I/II study in RA patients, where half the patients receiving doses of
above approximately 35mg achieved ACR-20.
"These results are very encouraging," said Lisa N. Drakeman, Ph.D.,
Chief Executive Officer. "The biological effect of HuMax-CD4 seen in the
Phase I/II study is confirmed here. I look forward to the ongoing development
of this promising antibody."
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