Genmab A/S (CSE:
GEN) announced today it has initiated a Phase II study of HuMax-CD20(TM)
(ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to
treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
A total of 56 patients will be enrolled in the study.
"Disease progression in patients with advanced CLL is usually rapid and
we hope using HuMax-CD20 in combination with FC as first line therapy will
result in significant disease improvement for these patients," said Lisa N.
Drakeman, Ph.D., Chief Executive Officer of Genmab.
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 HuMax-CD20 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 in the study is to determine the efficacy of HuMax-CD20
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 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 and Amgen. 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. In addition, Genmab has developed
UniBody(TM), a new proprietary technology that creates a stable, smaller
antibody format. Genmab has operations in Copenhagen, Denmark, Utrecht, the
Netherlands, Princeton, New Jersey, US and Hertfordshire in the United
Kingdom. 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);
HuMax-CD38(TM); and UniBody(TM) are all trademarks of Genmab A/S.
UltiMAb(R) is a trademark of Medarex, Inc.
Genmab A/S
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