Genmab A/S Recruitment Completed in Ofatumumab NHL Front Line Study Summary
COPENHAGEN, September 22 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 previously untreated follicular non-Hodgkin's lymphoma (NHL) patients in the Phase II study of ofatumumab (HuMax-CD20(R)) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP).
"We are happy to finish enrolment in this first study with ofatumumab in front line follicular NHL patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer at Genmab. "We look forward to seeing the results of this trial."
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 open label study were randomized into two dose groups of 28 patients each and receive a total of 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 every 3 weeks, in combination with 6 cycles of CHOP. Disease status will be assessed at 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 administration of ofatumumab assessed according to the standardized response 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 futher 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.
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