Genmab A/S announced that Amgen, Inc. released positive interim data from the ongoing HuMax-IL15/AMG 714 Phase II study in rheumatoid arthritis (RA).

The interim analysis covered 110 patients and showed a significant difference between treated patients and those in the placebo group. Patients in the study received HuMax-IL15/AMG 714 or placebo every other week for 12 weeks. Dose levels included placebo, 40 mg, 80 mg, 160 mg or 280 mg with the primary endpoint at week 14. Responses were measured at weeks 4, 8, 12, and 14 and the analysis was pooled so that data from patients in all dose groups was presented together.

Amgen also discussed previously disclosed pre-clinical data covering psoriasis and the possibility that HuMax-IL15/AMG 714 may be useful in other indications than RA and may also be useful in combination therapies.

HuMax-IL15 has been safe and well tolerated in clinical trials to date with no dose limiting toxicities. In addition, currently available pharmacokinetic data supports dosing every other week.

Amgen is adding patients to the study with a goal of finishing the Phase II study in 2004.

"This positive Phase II data helps confirm the potential of HuMax-IL15 in rheumatoid arthritis," said Lisa Drakeman, CEO of Genmab.