COPENHAGEN, Denmark, Oct. 26, 2010 (GLOBE NEWSWIRE) -- Genmab announces the start of a Phase III head to head study of ofatumumab versus rituximab in follicular NHL.
Genmab A/S (Copenhagen:GEN) announced today the start of a Phase III study of single agent ofatumumab compared to single agent rituximab in patients with follicular non-Hodgkin's lymphoma (NHL) that has relapsed at least 6 months after completion of treatment with a rituximab-containing regimen to which they responded.
Approximately 516 patients in this open-label study will be randomized to receive ofatumumab (1000 mg) or rituximab (375 mg/m2) by intravenous infusion for four weekly doses. Patients who have stable or responsive disease will then receive single infusions of ofatumumab or rituximab every two months for four additional doses for a total of eight doses over nine months. The primary endpoint of the study is progression free survival.
About ofatumumab
Ofatumumab is a novel human monoclonal antibody. It targets a part of the CD20 molecule on B-cells encompassing an epitope on the small and large loops. Ofatumumab is not approved in any country for indolent B-cell non-Hodgkin's lymphoma (B-NHL).
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab's world class discovery and development teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit www.genmab.com.
Contact: Helle Husted, Vice President, Investor Relations T: +45 33 44 77 30, M: +45 25 27 47 13, E: h.husted@genmab.com
This Stock Exchange 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. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's Annual Report, which is available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Stock Exchange Release nor to confirm such statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-TF(TM); HuMax-Her2(TM); HuMax-Wnt(TM); HuMax-cMet(TM) and UniBody(R) are all trademarks of Genmab A/S. Arzerra(R) is a trademark of GlaxoSmithKline.
Stock Exchange Release no. 43