Genmab A/S: Ofatumumab Pivotal CLL Data to be Presented at ASH
Responses Significantly Correlated to Overall Survival
COPENHAGEN, November 10, 2008 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today that three ofatumumab (HuMax-CD20(R)) abstracts have been accepted for presentation at the 50th American Society of Hematology Annual Meeting and Exposition (ASH) December 6-9, 2008. Updated interim efficacy data from the pivotal study evaluating ofatumumab to treat two groups of chronic lymphocytic leukemia (CLL) patients with an unmet medical need will be presented in an oral session. Headline interim data from the study was announced in July 2008.
In addition, two abstracts on pre-clinical ofatumumab data have been accepted for presentation at poster sessions. All three ofatumumab abstracts are available on the ASH website at http://www.hematology.org.
Oral Presentation December 8 at 11:45AM PST - Ofatumumab (HuMax-CD20), a Novel CD20 Monoclonal Antibody, Is An Active Treatment for Patients with CLL Refractory to Both Fludarabine and Alemtuzumab or Bulky Fludarabine-Refractory Disease: Results from the Planned Interim Analysis of An International Pivotal Trial.
Poster I-682 - Complement (C) Activation Followed by Penetration of the Membrane Attack Complex (MAC) on B Cells Opsonized with CD20 Mabs Allows for Calcium Influx Which Induces Streamers.
Poster I-683 - Binding of Submaximal C1q to B Cells Opsonized with Anti-CD20 Mabs Ofatumumab (OFA) or Rituximab (RTX) Promotes Complement Dependent Cytotoxicity (CDC), and Considerably Higher Levels of CDC Are Induced by OFA Than by RTX.
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 chronic lymphocytic leukemia, 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 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, development and manufacturing 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 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.
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Stock Exchange Release no. 53/2008
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Posted: November 2008