Advertisement
"The addition of a subcutaneous method of administrating ofatumumab is agreat addition to the ofatumumab development program. We hope this will infuture prove to be an advantage to RA patients, who would potentially be ableto administer ofatumumab on an outpatient basis," said Lisa N. Drakeman,Ph.D., Chief Executive Officer of Genmab.
Advertisement
Ofatumumab is an investigational drug being developed to treat chroniclymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse large B-celllymphoma and rheumatoid arthritis under a co-development andcommercialization agreement between Genmab and GlaxoSmithKline. It is not yetapproved in any country.
About the trial This is a two part study. The objective of Part A of thestudy is to characterize the safety and tolerability of ofatumumab whenadministered subcutaneously. The primary endpoint is safety and tolerability.The primary endpoint for Part B is to characterize thepharmacokinetics/pharmacodynamics of subcutaneous dosing. Patients in bothPart A and Part B are allowed to continue a stable dose methotrexate therapy.
Part A will be a randomized, single-blind, placebo controlled, repeatdose, parallel group, dose-range finding study of approximately 40 patients.Administration of ofatumumab for Part A will occur in a hospital based unitin order to ensure safety.
Part B will be a blinded, randomized, placebo controlled study. On thebasis of findings in Part A of the study selected doses will be taken forwardfor administration in Part B. Dosing for Part B is planned to be conducted onan outpatient basis.
About RA RA is a chronic systemic inflammatory disease which affects0.8-1.0% of all populations. RA patients suffer from damage and disruption ofjoints beginning early in the course of their disease. For most patients boneerosion progress will lead to joint deformities. Unless the inflammatoryprocesses are halted or controlled, the disease will lead to disability,co-morbidities, and in many cases also premature death.
About Genmab A/S Genmab is a leading international biotechnology companyfocused on developing fully human antibody therapeutics for unmet medicalneeds. Using cutting-edge antibody technology, Genmab's world classdiscovery, development and manufacturing teams have created and developed anextensive pipeline of products for potential treatment of a variety ofdiseases including cancer and autoimmune disorders. As Genmab advancestowards a commercial future, we remain committed to our primary goal ofimproving the lives of patients who are in urgent need of new treatmentoptions. For more information on Genmab's products and technology, visithttp://www.genmab.com.
This press release contains forward looking statements. The words"believe", "expect", "anticipate", "intend" and "plan" and similarexpressions identify forward looking statements. Actual results orperformance may differ materially from any future results or performanceexpressed or implied by such statements. The important factors that couldcause our actual results or performance to differ materially include, amongothers, risks associated with product discovery and development,uncertainties related to the outcome and conduct of clinical trials includingunforeseen safety issues, uncertainties related to product manufacturing, thelack of market acceptance of our products, our inability to manage growth,the competitive environment in relation to our business area and markets, ourinability to attract and retain suitably qualified personnel, the
