Genmab A/S (CSE:
GEN) announced today it has initiated a pivotal study to treat follicular
non- Hodgkin's lymphoma (NHL) patients who are refractory to rituximab.
The pivotal study will include approximately 162 NHL patients who are
refractory to rituximab in combination with chemotherapy or to rituximab
given as maintenance treatment.
"NHL is the second indication to enter a pivotal study for
HuMax-CD20(TM)," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab. "We now have two possible pathways to initial approval for
HuMax-CD20 targeting two different disease indications."
About the trial
Patients in the study will be randomized into two dose groups. Patients
in each dose group will receive one infusion of 300 mg of HuMax-CD20
followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20.
Disease status will be assessed every 3 months until month 24.
The objective of the study is to determine the efficacy and safety of
two dose regimens of HuMax-CD20. The primary endpoint of the study is
objective response as measured over a 6 month period from start of
treatment assessed by an Independent endpoints Review Committee (IRC)
according to the standardized response criteria for non-Hodgkin's
lymphomas.
Conference Call
Genmab will hold a conference call to discuss the news today, Monday,
July 10, 2006 at:
8.30 am CEST
7.30 am BST
2.30 am EDT
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, Amgen and Serono. A broad alliance provides Genmab with access
to Medarex, Inc.'s array of proprietary technologies, including the
UltiMAb(R) platform for the rapid creation and development of human
antibodies to virtually any disease target. Genmab has operations in
Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New Jersey in
the US. For more information about Genmab, visit genmab.
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-
EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM)
and HuMax-CD38(TM) are all trademarks of Genmab A/S.
UltiMAb(R) is a trademark of Medarex, Inc.
Genmab A/S
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