COPENHAGEN, Denmark, July 9 /PRNewswire/ -- Summary: Genmab has completed recruitment of patients in the Phase II study of ofatumumab in combination with fludarabine and cyclophosphamide to treat front line CLL.
Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 patients in the Phase II study of ofatumumab (HuMax-CD20 (R)) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
"We are pleased to complete patient enrollment in the first front line study of ofatumumab and hope to see a positive outcome for the CLL patients in this trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is an investigational fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 molecule on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 molecule. 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 in any country.
About the trial
Patients in this open label study will be randomized into two treatment groups of 28 patients each. Each patient will receive 6 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status will be measured every 4 weeks until week 24 according to National Cancer Institute Working Group Guidelines and every 3 months thereafter until disease progression or 24 months. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 48 months.
The objective of the study is to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary endpoint is complete remission measured at any time during the treatment period.
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. 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-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30, E: hth@genmab.com
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30, E: hth@genmab.com
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