Genmab A/S (OMX:
GEN) announced it has amended the design of an ongoing pivotal study
of ofatumumab (HuMax-CD20(R)) in rituximab refractory follicular
non Hodgkin's lymphoma (NHL) to a single arm trial that will now include
approximately 81 patients. All patients will receive one infusion of 300 mg
of ofatumumab followed by 7 weekly infusions of 1000 mg of ofatumumab. The
original study design included 162 patients, who would have received one
infusion of 300 mg of ofatumumab followed by 7 weekly infusions of either
500 or 1000 mg of ofatumumab. This is the first study of ofatumumab
dedicated to patients with rituximab-refractory follicular lymphoma.
In order to establish that ofatumumab is efficacious in this refractory
setting, reducing the number of patients in the trial will help to expedite
a result. The lower dose (500 mg) was dropped to reduce the total number of
patients to be accrued and ensure that these very sick patients receive the
maximum dose. Data from patients who were already treated in the 500 mg
dose group will be analyzed for safety and included in the secondary
efficacy analysis, but will not be included in the primary efficacy
analysis.
"This change to the pivotal study design will allow us to treat all the
refractory patients with a higher dose level of ofatumumab, allowing the
maximum opportunity for response and longer lasting effects in this patient
population," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab. Ofatumumab is an investigational drug being developed under a
co-development and commercialization agreement between Genmab and
GlaxoSmithKline. It is not yet approved in any market.
About Genmab A/S
Genmab is a leading international biotechnology company focused on
developing fully human antibody therapeutics for unmet medical needs. Using
unique, cutting-edge antibody technology, Genmab's world class discovery
and development 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-Inflam(TM); HuMax-TAC(TM);
HuMax-HepC(TM); HuMax-CD38(TM); HuMax-ZP3(TM); and UniBody(TM) are all
trademarks of Genmab A/S.
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