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Genmab announced today a Phase I/II study to evaluate a subcutaneous route of administration of ofatumumab (HuMax-CD20(R)) in rheumatoid arthritis (RA) patients, stable on methotrexate will be initiated soon
Copenhagen, Denmark | June 10, 2008 | Genmab A/S (OMX: GEN) announced today a Phase I/II study to evaluate a subcutaneous route of administration of ofatumumab (HuMax-CD20(R)) in rheumatoid arthritis (RA) patients, stable on methotrexate will be initiated soon. The study, which will consist of two parts and include approximately 70 patients, will be conducted by GlaxoSmithKline.
“The addition of a subcutaneous method of administrating ofatumumab is a great addition to the ofatumumab development program. We hope this will in future prove to be an advantage to RA patients, who would potentially be able to administer ofatumumab on an outpatient basis,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is an investigational drug being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin’s lymphoma, diffuse large B-cell lymphoma and rheumatoid arthritis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
About the trial
This is a two part study. The objective of Part A of the study is to characterize the safety and tolerability of ofatumumab when administered subcutaneously. The primary endpoint is safety and tolerability. The primary endpoint for Part B is to characterize the pharmacokinetics/pharmacodynamics of subcutaneous dosing. Patients in both Part A and Part B are allowed to continue a stable dose methotrexate therapy.
Part A will be a randomized, single-blind, placebo controlled, repeat dose, parallel group, dose-range finding study of approximately 40 patients. Administration of ofatumumab for Part A will occur in a hospital based unit in order to ensure safety.
Part B will be a blinded, randomized, placebo controlled study. On the basis of findings in Part A of the study selected doses will be taken forward for administration in Part B. Dosing for Part B is planned to be conducted on an outpatient basis.
About RA
RA is a chronic systemic inflammatory disease which affects 0.8-1.0% of all populations. RA patients suffer from damage and disruption of joints beginning early in the course of their disease. For most patients bone erosion progress will lead to joint deformities. Unless the inflammatory processes are halted or controlled, the disease will lead to disability, co-morbidities, and in many cases also premature death.
SOURCE: Genmab A/S |
