Copenhagen, Denmark; October 18, 2004 – Genmab A/S (CSE:
GEN) announced today that additional data is being presented at the
American College of Rheumatology Annual Scientific Meeting with respect to
the first 110 patients treated with AMG 714 (formerly HuMax™-IL15) in a
Phase II rheumatoid arthritis (RA) study. The data showed that at week 14,
the primary endpoint, those taking the higher doses of AMG 714 had the
greatest reduction in disease activity and the lowest frequency of disease
flare up, while those on placebo often worsened.
Patients were assessed according to the recognized ACR score which measures
a reduction in the disease. 57% of patients in the 280 mg group
demonstrated an ACR 20 score, with 24% of patients in this dose group
achieving an ACR 50 score. In the placebo arm, 35% of patients recorded an
ACR 20 score, with 4% gaining an ACR 50 score. In the second highest
dose group of 160 mg, 59% of patients recorded an ACR 20 score and 18% of
patients reached ACR 50 score. In the 80 mg group, 48% of patients reached
ACR 20 score and 30% achieved an ACR 50 score. In the 40 mg dose
group, 43% achieved an ACR 20 score and 19% gained an ACR 50 score.
Although the data at week 14 are not statistically significant versus
placebo, this is an interim analysis of an ongoing pilot study reporting on
the first 110 patients from a total of 180 patients.
AMG 714 was well tolerated, and generated adverse events similar to that of
placebo.
“We are encouraged by the results we have seen so far using AMG 714 to
treat RA,” said Lisa N. Drakeman, Ph.D. Chief Executive Officer of Genmab.
“We look forward to the data from the additional patients enrolled by Amgen
in this trial.”
About the trial
Patients who had previously failed treatment with disease modifying agents
were randomized into five groups. The groups received either placebo, 40, 80, 160 or 280 mg of AMG 714 by
subcutaneous injection every two weeks for 12 weeks. The trial
endpoint was week 14 and clinical and safety assessments were performed at
2-week intervals for 16 weeks and monthly over the following 8 weeks. Amgen
plans to enroll an additional 70 patients in this study.
The data are being presented today at the Annual Scientific Meeting of the
American College of Rheumatology (ACR) at 11.40 am (local time) by Dr. Iain
McInnes of the University of Glasgow.
In July 2003, Genmab announced that Amgen exercised its commercial option
to AMG 714 and would be responsible for all further development costs for
the antibody.
About AMG 714
AMG 714 is a high-affinity human monoclonal IgG1 antibody that binds to
Interleukin-15 (IL-15) and is being developed by Amgen under a license from
Genmab. IL-15 is a cytokine, an immune system signaling molecule.
Laboratory studies have shown that IL-15 appears early in the cascade of
events that ultimately leads to inflammatory disease and IL-15 is a
particularly interesting disease target because it is believed to be
involved in several steps of the inflammation cycle. Pre-clinical studies
have shown that IL-15 induces both the production of TNF-alpha, another
cytokine that has been shown to play a pivotal role in inflammation, as
well as the recruitment of inflammatory T-cells. These T-cells in turn
promote the production of more IL-15 and the cycle escalates.