COPENHAGEN, Denmark, March 21 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) announced today additional data from the HuMax-CD20(TM) Phase I/II study to treat patients with active rheumatoid arthritis (RA). In patients who received two doses of HuMax-CD20, 38% (10/26) achieved ACR50 and 15% (4/26) achieved ACR70.
There were three dose levels in the study with results as follows: -- In the 300 mg dose group -- 25% (2/8) of patients achieved ACR50 -- 13% (1/8) achieved ACR70 -- In the 700 mg dose group -- 44% (4/9) achieved ACR50 -- 22% (2/9) achieved ACR70 -- In the 1000 mg dose group -- 44% (4/9) achieved ACR50 -- 11% (1/9) achieved ACR70
After re-examination of the previously reported ACR20 data, it appears one of the responders in the 300 mg dose group had received only one dose of HuMax-CD20, thus 73% (19/26) of patients treated with two doses of HuMax-CD20 achieved ACR20. The intent to treat analysis remains the same, with 63% of patients achieving ACR20.
"During the conduct of this Phase I/II study and the ongoing Phase II study in RA we have reduced the side effects associated with the infusion by intensifying the pre-medication. We believe that the safety profile of HuMax- CD20 in this patient population looks favorable compared to other therapies and that only very few patients will have problems tolerating the full dose planned," said Claus Moller, M.D., Ph.D., Chief Operating Officer of Genmab. "This is supported by the ongoing enrolment in the Phase II study where 101 patients have received treatment with HuMax-CD20."
"These ACR50 and ACR70 results look very promising," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab, "and we are looking forward to future development of the product."
These data were presented today at the 10th Anniversary Inflammation and Immune Diseases, Drug Discovery and Development Summit in New Brunswick, New Jersey by Dr. Mikkel Ostergaard, Professor of Rheumatology at Hvidovre Hospital.
For more background information on the study, please see the press release dated March 8, 2006.
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, Amgen and Serono. 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.
Genmab(R); HuMax(R); HuMax-CD4(R); HuMax-EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM) and the Y-shaped Genmab logo are all trademarks of Genmab A/S.
UltiMAb(R) is a trademark of Medarex, Inc.
Genmab A/SCONTACT: Helle Husted, Director, Investor Relations, Genmab, +45 33 44 7730, or Mobile: +45 25 27 47 13, or Email: hth@genmab.com
Web site: http://www.genmab.com/
