COPENHAGEN, Denmark, June 14 /PRNewswire-FirstCall/ -- Genmab A/S announced today it has initiated a Phase II study of ofatumumab (HuMax-CD20(R)) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in patients with previously untreated follicular non-Hodgkin's lymphoma (NHL). A total of 56 patients will be enrolled in the study which is being conducted under Genmab's collaboration with GlaxoSmithKline.
"We are pleased to begin this study of ofatumumab for front line treatment offollicular NHL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab, "which we hope may be more effective than currently available treatment."
About the trial
Patients in this open label study will be randomized into two dose groups of 28patients each and will receive 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 every3 weeks, in combination with 6 cycles of CHOP. Disease status will be assessedat 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 treatment assessed according to the standardized response criteria for NHL at 30 weeks.
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. In addition, Genmab has developed UniBody(TM), a new proprietary technology that creates astable, smaller antibody format. Genmab has operations in Europe and the US.For more information about Genmab, visit http://www.genmab.com/.
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-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 GenmabA/S.
Contact:
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