Responses Significantly Correlated to Overall Survival
Summary: Three ofatumumab abstracts have been accepted for presentation at the
ASH meeting December 6-9, 2008.
Copenhagen, Denmark; November 10, 2008 - Genmab A/S (OMX: GEN) announced today
that three ofatumumab (HuMax-CD20(R)) abstracts have been accepted for
presentation at the 50th American Society of Hematology Annual Meeting and
Exposition (ASH) December 6-9, 2008. Updated interim efficacy data from the
pivotal study evaluating ofatumumab to treat two groups of chronic lymphocytic
leukemia (CLL) patients with an unmet medical need will be presented in an oral
session. Headline interim data from the study was announced in July 2008.
In addition, two abstracts on pre-clinical ofatumumab data have been accepted
for presentation at poster sessions. All three ofatumumab abstracts are
available on the ASH website at www.hematology.org.
ASH Sessions
Oral Presentation December 8 at 11:45AM PST - Ofatumumab (HuMax-CD20), a Novel
CD20 Monoclonal Antibody, Is An Active Treatment for Patients with CLL
Refractory to Both Fludarabine and Alemtuzumab or Bulky Fludarabine-Refractory
Disease: Results from the Planned Interim Analysis of An International Pivotal
Trial.
Poster I-682 - Complement (C) Activation Followed by Penetration of the Membrane
Attack Complex (MAC) on B Cells Opsonized with CD20 Mabs Allows for Calcium
Influx Which Induces Streamers.
Poster I-683 - Binding of Submaximal C1q to B Cells Opsonized with Anti-CD20
Mabs Ofatumumab (OFA) or Rituximab (RTX) Promotes Complement Dependent
Cytotoxicity (CDC), and Considerably Higher Levels of CDC Are Induced by OFA
Than by RTX.
Ofatumumab is an investigational, new generation, human monoclonal antibody that
targets a distinct membrane proximal, small loop epitope (specific binding site)
of the CD20 molecule on the surface of B-cells. Ofatumumab is being developed to
treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse
large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple
sclerosis under a co-development and commercialization agreement between Genmab
and GlaxoSmithKline. It is not yet approved for sale in any country.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery, development and manufacturing teams are using
cutting-edge technology to create and develop products to address unmet medical
needs. Our primary goal is to improve the lives of patients who are in urgent
need of new treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.
This press release contains forward looking statements. The words “believe”,
“expect”, “anticipate”, “intend” and “plan” and similar expressions identify
forward looking statements. Actual results or performance may differ materially
from any future results or performance expressed or implied by such statements.
The important factors that could cause our actual results or performance to
differ materially include, among others, risks associated with product discovery
and development, uncertainties related to the outcome and conduct of clinical
trials including unforeseen safety issues, uncertainties related to product
manufacturing, the lack of market acceptance of our products, our inability to
manage growth, the competitive environment in relation to our business area and
markets, our inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and proprietary rights,
our relationships with affiliated entities, changes and developments in
technology which may render our products obsolete, and other factors. For a
further discussion of these risks, please refer to the section “Risk Management”
in Genmab's Annual Report, which is available on www.genmab.com. Genmab does
not undertake any obligation to update or revise forward looking statements in
this press release nor to confirm such statements in relation to actual results,
unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM);
HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM)
and UniBody(R) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45 33 44 77 30, M:
+45 25 27 47 13, E: hth@genmab.com
Stock Exchange Release no. 53/2008
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