Genmab Amends Ofatumumab Pivotal Study In NHL To Single Arm Study

Main Category: Lymphoma / Leukemia
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 28 Sep 2007 - 2:00 PDT

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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 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 Genmab A/S.

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