Summary: Genmab has initiated a Phase II study of ofatumumab in relapsed
Diffuse Large B-Cell Lymphoma.
Copenhagen, Denmark; December 13, 2007 - Genmab A/S (OMX: GEN) announced today
that study centers have been initiated and are ready to enroll patients in a
Phase II study of ofatumumab (HuMax-CD20(R)) to evaluate treatment of relapsed
Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed
following a stem cell transplant. Approximately 75 patients will be enrolled in
the study which is being conducted under Genmab's collaboration with
GlaxoSmithKline (GSK). Genmab will receive a milestone payment of approximately
DKK 87.2 million from GSK upon treatment of the first patient in the study,
expected in the near future.
Ofatumumab is an investigational, fully human, next generation monoclonal
antibody that targets a unique epitope of the CD20 receptor on the surface of
B-cells. Other anti-CD20 antibodies currently available or in development bind
to a different epitope on the CD20 receptor. Ofatumumab is being developed under
a co-development and commercialization agreement between Genmab and
GlaxoSmithKline.
“We have now expanded the ofatumumab clinical development program into a fourth
disease area,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
“We hope ofatumumab will offer a new and effective treatment option for patients
suffering from DLBCL.”
About the trial
In this open label trial, each patient will receive 8 weekly infusions of
ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions
will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after
the last infusion and then every 3 months for a total of 24 months after
treatment start according to the “Revised response criteria for malignant
lymphoma.” After 24 months, patients will be followed until initiation of
alternative DLBCL treatment or month 60. The objective of the study is to
determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible
for transplant or relapsed after transplant. The primary endpoint of the study
is objective response over a 6 month period from start of treatment.
About Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma is a cancer of the B-lymphocytes and represents
30% of non-Hodgkin's lymphomas in adults and is the most common lymphoid
malignancy in the western world. There are an estimated 63,000 new cases of
DLBCL diagnosed in the US per year. The median age at diagnosis is about 65
years.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for unmet medical needs. Using unique,
cutting-edge antibody technology, Genmab's world class discovery and development
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);
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. 61/2007
###
