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Genmab Reports ACR50 And ACR70 Results In HuMax-CD20 Study To Treat RA |
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22 Mar 2006 |
Announced additional data from the HuMax-CD20™
COPENHAGEN, Denmark | Mar 21, 2006 | Genmab A/S (CSE: GEN) announced today additional data from the HuMax-CD20™ 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
o 25% (2/8) of patients achieved ACR50
o 13% (1/8) achieved ACR70
* In the 700 mg dose group
o 44% (4/9) achieved ACR50
o 22% (2/9) achieved ACR70
* In the 1000 mg dose group
o 44% (4/9) achieved ACR50
o 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 Møller, 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 Østergaard, Professor of Rheumatology at Hvidovre Hospital.
SOURCE: Genmab |
