Results of Genmab's HuMax-CD4 Phase II Psoriasis Study
13 December 2003 - 3:28AM
PR Newswire (US)
Results of Genmab's HuMax-CD4 Phase II Psoriasis Study COPENHAGEN,
Denmark, December 12 /PRNewswire/ -- - Summary: In a Phase IIb
psoriasis study, HuMax-CD4 did not achieve statistically
significant results. Genmab A/S (CSE: GEN) announced today
HuMax-CD4 did not achieve statistically significant results in a
118 patient Phase IIb study to treat psoriasis. Analysis of the
data indicated that HuMax-CD4 was safe and well tolerated in the
studies to date. There was also a statistically significant dose
dependent depletion of CD4+ T-cells. Genmab has no further plans to
develop HuMax-CD4 for the treatment of psoriasis. Genmab is
continuing its two Phase II studies with HuMax-CD4 to treat
cutaneous T- cell lymphoma after encouraging results were presented
this fall. About HuMax-CD4 HuMax-CD4 is a high affinity human
antibody that targets the CD4 receptor on T-lymphocytes. Genmab is
also running two Phase II studies concurrently using HuMax-CD4 to
treat cutaneous T-cell lymphoma (CTCL). Interim results using the
Physician's Global Assessment showed 55% of the early stage and 38%
of the advanced stage CTCL patients achieved at least a partial
response (more than 50% improvement in their disease). One early
stage patient's CTCL was completely cleared. In addition, 9% of the
early stage and 23% of the advanced stage patients achieved a minor
response (25- 50% improvement). In other measures of the disease
state, pruritus (severe and sometimes debilitating itching) was
improved in 82% of early stage patients and 69% of advanced stage
patients. Pruritus is most likely the single major parameter for
reducing quality of life in CTCL patients. Genmab is adding
patients to the Phase II CTCL studies at higher dose levels. The
dose level has been increased from the original 280mg per week for
16 weeks in the ongoing studies because CD4+ T-cells were not fully
depleted in the initial patients. The objective of using higher
doses is to improve responses by further reducing the number of
CD4+ T-cells and, thus, the number of cancer cells. At present, 10
early stage patients are being treated with 560mg per week and 7
advanced stage patients are being treated at the 980mg weekly dose
level. A review of the safety data has indicated that HuMax-CD4
appears to have been safe and well tolerated in clinical trials to
date. During the Phase II CTCL studies no Grade 4 adverse events
have occurred. There have been only four Grade 3 adverse events and
only one of those, skin hypersensitivity, was judged to be possibly
treatment related. In addition to CTCL, approximately half of the
non-cutaneous T-cell lymphomas express the CD4 receptor on their
cell surface and Genmab has also treated a non-cutaneous T-cell
lymphoma patient on a compassionate use basis with a good clinical
effect. Considering this and the encouraging data from the CTCL
study, Genmab is now making plans to initiate a study in non-
cutaneous T-cell lymphoma patients in the second half of 2004,
especially since these patients also have a dramatic need for new
and less toxic therapies. About Genmab A/S Genmab A/S is a
biotechnology company that creates and develops human antibodies
for the treatment of life-threatening and debilitating diseases.
Genmab has numerous 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 has
multiple partnerships to gain access to disease targets and develop
novel human antibodies including agreements with Roche and Amgen. A
broad alliance provides Genmab with access to Medarex, Inc.'s array
of proprietary technologies, including the UltiMAb(TM ) platform
for the rapid creation and development of human antibodies to
virtually any disease target. Genmab is headquartered in
Copenhagen, Denmark and has operations in Utrecht, The Netherlands
and Princeton, New Jersey in the US. For more information about
Genmab, visit www.genmab.com. Except for the historical information
presented herein, matters discussed in this press release are
forward-looking statements that are subject to certain risks and
uncertainties that could cause actual results to differ materially
from any future results, performance or achievements expressed or
implied by such statements, e.g. unforeseen exchange rate and
interest rate fluctuations, delayed or unsuccessful development
projects. Statements that are not historical facts, including
statements preceded by, followed by, or that include the words
"believes"; "anticipates"; " plans"; "expects"; "estimates"; or
similar statements are forward-looking statements. Genmab is not
under an obligation to up-date statements regarding the future
following the publication of this release; nor to confirm such
statements in relation to actual results, unless this is required
by law. Web site: http://www.genmab.com DATASOURCE: Genmab A/S
CONTACT: Sisse P. Hansen, Investor & Public Relations, Genmab
A/S, +45 33 44 77 76, or mobile: +45 25 27 47 27, or email:
sha@genmab.com
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