COPENHAGEN, Denmark, June 10 /PRNewswire-FirstCall/ -- 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.
About Genmab A/S Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using cutting-edge antibody technology, Genmab's world class discovery, development and manufacturing teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit http://www.genmab.com.
This press release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30, M: +45-25-27-47-13, E: email@example.com
Stock Exchange Release no. 30/2008
|SOURCE Genmab A/S|
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