Press Center » Archived News Releases » 2000
Copenhagen, Denmark; December 13, 2000 - Genmab A/S (CSE:
GEN and Neuer Markt: GE9D) announced today that it has initiated a Phase II
clinical trial with its fully human antibody HuMax-CD4(TM) to treat patients
with rheumatoid arthritis. HuMax-CD4 will be administered in multiple doses
in combination with methotrexate. The study will include four different dose
levels plus a placebo arm and it is designed to provide safety and efficacy
data, as well as dose finding information.
HuMax-CD4 Phase I/II results were presented at the American College of
Rheumatology meeting in Philadelphia in November and showed that the fully
human antibody was well tolerated and that patients' CD4 counts remained
stable in response to the treatment. In this single dose study, the four
highest dose cohorts, 0.5, 1, 2 and 4 mg/kg, fifty percent of the treated
patients achieved favorable responses to the antibody, as measured by
objective criteria defined by the American College of Rheumatology and
routinely used by companies seeking regulatory approval of arthritis
products. Eight of 16 achieved ACR 20, one of those achieved ACR 50, and two
of the group achieved ACR 70.
"The Genmab clinical development team has made excellent progress by
initiating this clinical trial so soon after finishing the Phase I/II
study," said Lisa. N. Drakeman, Ph.D., Chief Executive Officer
"Rheumatoid arthritis affects millions of people who need new therapies
for this debilitating disease."
Genmab A/S is a biotechnology company that creates and
develops fully human antibodies for the treatment of life-threatening and
debilitating diseases. Genmab has four products in development to treat
cancer, rheumatoid arthritis and other inflammatory conditions, and intends
to assemble a broad portfolio of new therapeutic products arising from
research into the human genome. At present, Genmab's commercial
opportunities are based upon research conducted at leading international
companies, such as Immunex, Oxford GlycoSciences, Eos Biotechnology and
Medarex, as well as in its own laboratories. A broad alliance provides Genmab
with access to Medarex's array of proprietary technologies, including the
HuMAb-Mouse®, for the rapid creation and development of fully human
antibodies to virtually any disease target. For more information about
Genmab, visit www.genmab.com.
Except for the historical information presented, certain matters discussed
in this press release are forward looking statements that are subject to a
number of risks and uncertainties that could cause actual results to differ
materially from results, performance or achievements expressed or implied by
such statements such risks and uncertainties associated with product
discovery and development including statements regarding the Company's
clinical development programs and the expected timing of clinical trials and
regulatory filings. Such statements are based on management's current
expectations, but actual results may differ materially.
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