Genmab A/S (OMX:
GEN) announced it has completed recruitment of patients in the
pivotal Phase III study of ofatumumab (HuMax-CD20(R)) in rituximab
refractory follicular non-Hodgkin's lymphoma (NHL). Eighty-one patients
receiving treatment at the 1000 mg dose level of ofatumumab have been
recruited in the study. Data from these patients will be included in the
primary efficacy analysis. An additional 31 patients were recruited at a
500 mg dose level prior to amending the study design to include only one
dose. Data from these patients will be evaluated for safety and supportive
efficacy analysis.
"We have now recruited the last patient into the study and keenly await
the results which we hope will show a benefit for follicular NHL patients
who need a new treatment option," said Lisa N. Drakeman, Ph.D., Chief
Executive Officer of Genmab.
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 study will receive one infusion of 300 mg of
ofatumumab followed by 7 weekly infusions of 1000 mg of ofatumumab. Disease
status will be assessed every 3 months until month 24.
The objective of the study is to determine the efficacy and safety of
ofatumumab in rituximab refractory follicular NHL. 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 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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"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
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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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