Genmab Initiates HuMax(R)-CD20 Phase II Study In Rheumatoid Arthritis
Posted on: Tuesday, 16 August 2005, 09:00 CDT
COPENHAGEN, Denmark, Aug. 16 /PRNewswire-FirstCall/ -- Genmab A/S announced today it has initiated a Phase II study with HuMax-CD20 to treat patients with active rheumatoid arthritis (RA) who have failed one treatment with one or more disease modifying anti-rheumatic drugs (DMARDs). Genmab has completed treatment of 33 patients in a Phase I/II dose escalation trial and expanded the study into a Phase II trial, which will include 200 additional patients.
In the Phase II trial, a total of 200 patients will be randomized into four treatment groups. In each group, 50 patients will receive two infusions of either 300, 700, or 1000 mg doses of HuMax-CD20 or placebo. The doses will be given two weeks apart. Patients receiving a stable dose of methotrexate between 7.5 and 25 mg per week at the time of screening will continue with it. Patients will be followed for 24 weeks to evaluate safety and efficacy and then every 12 weeks until B-cell counts return to baseline levels.
About HuMax-CD20
HuMax-CD20 is a human antibody which is effective at binding to the CD20 molecule on B-cells. In June 2005, Genmab presented positive data from a Phase I/II trial with patients with relapsed or refractory follicular lymphoma showing response rates up to 63% in patients treated with HuMax-CD20. Further details can be found in the press release from June 10, 2005 on the press center site at http://www.genmab.com/.
A Phase I/II trial to treat patients with chronic lymphocytic leukemia is ongoing.
About CD20
The CD20 antigen is a transmembrane protein on pre-B and mature B lymphocytes. CD20 appears to act as a calcium ion channel, and to regulate early steps in B lymphocyte activation. The molecule is not shed from the cell surface, and is not internalized upon antibody binding. CD20 is found on over 90% of B-cell lymphomas, as well as other lymphoid tumors of B-cell origin. B-cells are crucial pathogenic elements in the induction and pathogenesis of RA. As B-cells are involved in various cellular interactions with immune cells, B-cell depletion after HuMax-CD20 treatment can be expected to affect RA disease activity.
About RA
Rheumatoid arthritis (RA) is a systemic inflammatory disease which affects 0.8-1.0% of all populations.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions, and intends to continue assembling a broad portfolio of new therapeutic products. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche and Amgen. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb(R) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New Jersey in the US. For more information about Genmab, 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 update 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.
UltiMAb(R) is a trademark of Medarex, Inc.
Genmab(R); HuMax(R); HuMax-CD4(TM) and the Y-shaped Genmab logo are all trademarks of Genmab A/S.
Genmab A/S
CONTACT: Helle Husted, Director, Investor Relations, Genmab,T: +45 33 44 77 30 or M: +45 25 27 47 13
Web site: http://www.genmab.com/
Source: PRNewswire-FirstCall
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