Summary: Genmab has initiated a Phase II study of ofatumumab in combination
with CHOP as front line treatment of follicular NHL.
Copenhagen, Denmark; June 14, 2007 - Genmab A/S (CSE: GEN) announced today it
has initiated a Phase II study of ofatumumab (HuMax-CD20®) in combination with
cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in patients
with previously untreated follicular non-Hodgkin's lymphoma (NHL). A total of
56 patients will be enrolled in the study which is being conducted under
Genmab's collaboration with GlaxoSmithKline.
“We are pleased to begin this study of ofatumumab for front line treatment of
follicular NHL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab, “which we hope may be more effective than currently available
treatment.”
About the trial
Patients in this open label study will be randomized into two dose groups of 28
patients each and will receive 6 infusions of ofatumumab in combination with
CHOP. Each patient will receive 300 mg of ofatumumab at the first infusion,
followed by 5 subsequent infusions of either 500 or 1000 mg of ofatumumab every
3 weeks, in combination with 6 cycles of CHOP. Disease status will be assessed
at three months following the last treatment and then every three months until
month 24, and every 6 months thereafter until 60 months or initiation of
alternative treatment.
The objective of the study is to determine the efficacy of two dose regimens of
ofatumumab in combination with CHOP in previously untreated follicular NHL
patients. The primary endpoint in the study is objective response from start
of treatment until 3 months after last treatment assessed according to the
standardized response criteria for NHL at 30 weeks.
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. In addition,
Genmab has developed UniBody(TM), a new proprietary technology that creates a
stable, smaller antibody format. Genmab has operations in Europe and the US.
For more information about Genmab, 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-Inflam(TM); HuMax-TAC(TM); HuMax-HepC(TM),
HuMax-CD38(TM); HuMax-ZP3(TM); and UniBody(TM) 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. 26/2007
