Press Center » Archived News Releases » 2000
PHILADELPHIA, PA; November 1, 2000 - Genmab A/S (CSE:GEN and
Neuer Markt:GE9) announced today positive results from a Phase I/II clinical
trial of HuMax™-CD4, a fully human antibody used to treat patients with
rheumatoid arthritis. HuMax-CD4 was well tolerated in this dose escalating,
placebo controlled study of 35 patients with severe rheumatoid arthritis, and
there was no evidence of depletion of patients' CD4 positive T cells.
Furthermore, in this single dose study, in 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 that
have been defined by the American College of Rheumatology and are routinely
used by companies seeking regulatory approval of arthritis products. Eight of
sixteen achieved ACR 20, one of those achieved ACR 50, and two of the group
achieved ACR 70.
These data were presented today at the American College of Rheumatology
Meeting in Philadelphia by Principal Investigator, Bo Baslund, M.D. of
Rigshospitalet, Copenhagen.
"We are very encouraged by the HuMax-CD4 results," said Lisa N.
Drakeman, Ph.D., Chief Executive Officer of Genmab. "There are millions
of people suffering from rheumatoid arthritis who are not responding to
currently available therapies."
"This level of safety and activity in Phase I/II studies with severely
diseased patients is unusually good," said Bo Baslund, M.D., Principal
Investigator. "I look forward to the upcoming Phase II studies."
HuMax-CD4 is a fully human antibody that targets the CD4 receptor on T-cells.
These cells are implicated early in the cascade of inflammatory events that
cause rheumatoid arthritis. The scientific rationale for blocking the
activity of these cells is to stop the inflammatory process.
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.
About HuMax™-CD4
HuMax™-CD4 is a high affinity fully human antibody created in the patented
HuMab- Mouse system. Affinity measures the strength with which an antibody
finds and adheres to its disease target. HuMax-CD4 has an unusually high
affinity, 10 to the 11th power, noticeably higher in affinity than the best
antibodies typically created in wild type mice. In addition to its unusual
ability to attach to its target, because HuMax-CD4 is a fully human antibody
it should not be recognized as a foreign protein by a patient's immune
system and may be potent for a longer period of time than antibodies that are
part mouse. It should also be less likely to cause immune reactions after
repeated treatments. HuMax-CD4 targets the CD4 receptor on T-cells. These
cells are implicated early in the cascade of inflammatory events that cause
rheumatoid arthritis, psoriasis and other inflammatory diseases. The
scientific rationale for blocking the activity of these cells is to stop the
inflammatory process. Genmab believes that all these factors may be important
in treating chronic inflammatory diseases like rheumatoid arthritis and
psoriasis.
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