Genmab A/S (OMX:
GEN) announced it has completed recruitment of 56 previously
untreated follicular non-Hodgkin's lymphoma (NHL) patients in the Phase II
study of ofatumumab (HuMax-CD20(R)) in combination with cyclophosphamide,
doxorubicin, vincristine and prednisone (CHOP).
"We are happy to finish enrolment in this first study with ofatumumab
in front line follicular NHL patients," said Lisa N. Drakeman, Ph.D., Chief
Executive Officer at Genmab. "We look forward to seeing the results of this
trial."
Ofatumumab is an investigational, new generation, human monoclonal
antibody that targets a distinct membrane proximal, small loop epitope
(specific binding site) of the CD20 molecule on the surface of B-cells.
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 for
sale in any country.
About the trial
Patients in this open label study were randomized into two dose groups
of 28 patients each and receive a total of 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 administration of ofatumumab
assessed according to the standardized response criteria for NHL.
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
genmab.
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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.
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