Summary: Genmab has completed recruitment of patients in the Phase II study of
ofatumumab in combination with fludarabine and cyclophosphamide to treat front
line CLL.
Copenhagen, Denmark; July 9, 2008 - Genmab A/S (OMX: GEN) announced today it has
completed recruitment of 56 patients in the Phase II study of ofatumumab
(HuMax-CD20 (R)) in combination with fludarabine and cyclophosphamide (FC) to
treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
“We are pleased to complete patient enrollment in the first front line study of
ofatumumab and hope to see a positive outcome for the CLL patients in this
trial,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is an investigational fully human, next generation monoclonal
antibody that targets a unique epitope of the CD20 molecule on the surface of
B-cells. Other anti-CD20 antibodies currently available or in development bind
to a different epitope on the CD20 molecule. Ofatumumab is being developed to
treat CLL, 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 in any country.
About the trial
Patients in this open label study will be randomized into two treatment groups
of 28 patients each. Each patient will receive 6 monthly infusions of either
500 or 1000 mg of ofatumumab in combination with FC. Disease status will be
measured every 4 weeks until week 24 according to National Cancer Institute
Working Group Guidelines and every 3 months thereafter until disease progression
or 24 months. Patients not having progressed on their disease at 24 months will
be followed for disease progression at 6 month intervals until 48 months.
The objective of the study is to determine the efficacy of ofatumumab in
combination with FC in previously untreated CLL patients. The primary endpoint
is complete remission measured at any time during the treatment period.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for unmet medical needs. Using cutting-edge
antibody technology, Genmab's world class discovery, development and
manufacturing teams have created and developed an extensive pipeline of products
for potential treatment of a variety of diseases including cancer and autoimmune
disorders. As Genmab advances towards a commercial future, we remain committed
to our primary goal of improving 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. 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.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(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, E:
hth@genmab.com
Stock Exchange Release no. 33/2008
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