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"We are happy to finish enrolment in this first study with ofatumumab infront line follicular NHL patients," said Lisa N. Drakeman, Ph.D., ChiefExecutive Officer at Genmab. "We look forward to seeing the results of thistrial."
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Ofatumumab is an investigational, new generation, human monoclonalantibody 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'slymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsingremitting multiple sclerosis under a co-development and commercializationagreement between Genmab and GlaxoSmithKline. It is not yet approved for salein any country.
About the trial
Patients in this open label study were randomized into two dose groups of28 patients each and receive a total of 6 infusions of ofatumumab incombination with CHOP. Each patient will receive 300 mg of ofatumumab at thefirst infusion, followed by 5 subsequent infusions of either 500 or 1000 mgof ofatumumab every 3 weeks, in combination with 6 cycles of CHOP. Diseasestatus will be assessed at three months following the last treatment and thenevery three months until month 24, and every 6 months thereafter until 60months or initiation of alternative treatment. The objective of the study isto determine the efficacy of two dose regimens of ofatumumab in combinationwith CHOP in previously untreated follicular NHL patients. The primaryendpoint in the study is objective response from start of treatment until 3months after last administration of ofatumumab assessed according to thestandardized response criteria for NHL.
About Genmab A/S
Genmab is a leading international biotechnology company focused ondeveloping fully human antibody therapeutics for unmet medical needs. Usingcutting-edge antibody technology, Genmab's world class discovery, developmentand manufacturing teams have created and developed an extensive pipeline ofproducts for potential treatment of a variety of diseases including cancerand autoimmune disorders. As Genmab advances towards a commercial future, weremain committed to our primary goal of improving the lives of patients whoare in urgent need of new treatment options. For more information on Genmab'sproducts and technology, visit http://www.genmab.com.
This press release contains forward looking statements. The words"believe", "expect", "anticipate", "intend" and "plan" and similarexpressions identify forward looking statements. Actual results orperformance may differ materially from any future results or performanceexpressed or implied by such statements. The important factors that couldcause our actual results or performance to differ materially include, amongothers, risks associated with product discovery and development,uncertainties related to the outcome and conduct of clinical trials includingunforeseen safety issues, uncertainties related to product manufacturing, thelack of market acceptance of our products, our inability to manage growth,the competitive environment in relation to our business area and markets, ourinability to attract and retain suitably qualified personnel, theunenforceability or lack of protection of our patents and proprietary rights,our relationships with affiliated entities, changes and developments intechnology which may render our products obsolete, and other factors. For afuther discussion of these risks, please refer to the section "RiskManagement" in Genmab's Annual Report, which is available onhttp://www.genmab.com. Gen
