Genmab to Present HuMax-CD4 Data at the Society for Investigative Dermatology Conference
19 February 2004 - 1:14AM
PR Newswire (US)
Genmab to Present HuMax-CD4 Data at the Society for Investigative
Dermatology Conference COPENHAGEN, Denmark, February 18
/PRNewswire/ -- - 67% of Early Stage and 50% of Advanced Stage
Patients Obtained CA Score Reduction of at Least 50% in High Dose
Group - Summary: Genmab's HuMax-CD4 Achieves Positive Interim
Results in Extended Phase II Studies for CTCL Genmab A/S (CSE: GEN)
announced today it will present data from Phase II HuMax-CD4
studies to treat cutaneous T-cell lymphoma (CTCL) at the 65th
Annual Meeting of the Society for Investigative Dermatology in
April. At the time the abstract was completed, 36 patients enrolled
in the two ongoing HuMax-CD4 clinical trials were evaluated using
the Composite Assessment of Index Lesion Disease Activity (CA)
score. These patients were treated at one of three dose levels as
follows: 280 mg (11 early stage and 10 advanced stage), 560 mg (9
early stage) or 980 mg (6 advanced stage). Following 280 mg, 33% of
21 patients obtained a 50% or better CA score reduction. Following
560 mg, 67% (six of nine early stage patients) obtained a CA score
reduction of 50% or better, including two who obtained a 100%
reduction. Three other early stage patients had stable disease.
Following 980 mg, 50% (three of six) advanced stage patients
obtained a CA score reduction of more than 50% and three patients
had stable disease. Following 280 mg dosing, 6 grade 3 adverse
events were reported by 4 patients. 5 were unrelated to HuMax-CD4.
Following 560 and 980 mg, 1 unrelated grade 3 adverse event was
reported. No grade 4 events were reported. HuMax-CD4 has been found
to be safe and well tolerated by patients with CTCL in clinical
studies to date. At present, 15 early stage patients are enrolled
in the 560 mg treatment group and 10 late stage patients are
enrolled in the 980 mg treatment group. At the time of the
presentation on April 30, 2004, more complete data covering more of
these patients for a longer period of time is expected to be
available. "The higher doses of HuMax-CD4 are showing a positive
effect in these studies so far," said Lisa N. Drakeman, Ph.D.,
Chief Executive Officer of Genmab. "We are pleased because there is
a need for new therapy for CTCL." About HuMax-CD4 HuMax-CD4 is a
high affinity human antibody that targets the CD4 receptor on
T-lymphocytes. Genmab is running two Phase II studies concurrently
using HuMax-CD4 to treat cutaneousT-cell lymphoma (CTCL). Disease
prevalence T-cell lymphomas positive for the CD4 receptor
constitute around 5% of Non-Hodgkin's Lymphomas. There are about
1,000 new cases of CTCL per year in the US and the prevalence of
the disease is estimated at 16,000 to 20,000. CTCL patients tend to
have a lifespan of 10 to 30 years and therefore could be treated
several times during the disease progression. 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, Genmabis 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. Non-cutaneous
T-cell lymphomas that arepositive for the CD4 receptor are
predominantly of the nodal subtype. This includes peripheral and
angioimmunoblastic T-cell lymphomas of which 75% are CD4 positive
and anaplastic large cell lymphomas of which 20% are. The combined
incidence of these lymphomas is approximately 2,770 in the US and
Canada and 3,280 in industrialized Europe. Their prevalence in
Europe is approximately 10,000 and in US and Canada it ranges from
8,000 to 10,000. Conference Call Genmab's Management will hold a
conference call to discuss the HuMax-CD4 Phase II results, today,
Wednesday, February 18, at 3:00 p.m. CET 2:00 p.m. GMT 9:00 a.m. US
Eastern Time The dial in numbers are as follows: +1-800-915-4836
(in the US) and ask for the Genmab conference call +1-973-317-5319
(outside the US) and ask for the Genmab conference call The
conference call will be held in English. 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, infectious disease, rheumatoid arthritis and other
inflammatory conditions, and intends to continue assembling a broad
portfolio of new therapeutic products. 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 headquarteredin 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 update 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, T: +45 33
44 77 76, M: +45 25 27 47 27, E: sha@genmab.com
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