Recruitment Completed In Ofatumumab NHL Pivotal Study

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 24 Sep 2008 - 0:00 PDT

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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 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. For a further discussion of these risks, please refer to the section "Risk Management"in Genmab's Annual Report, which is available on http://www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this press 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-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.

Genmab A/S
http://www.genmab.com