Genmab A/S - Company Announcement Ofatumumab in Subcutaneous Study in Rheumatoid Arthritis Summary: Subcutaneous Administration of Ofatumumab Investigated in Phase I/II Study
10/06/2008 21:36
PR Newswire
COPENHAGEN, Denmark, June 10 /PRNewswire/ -- 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: hth@genmab.com
Stock Exchange Release no. 30/2008
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30, M: +45-25-27-47-13, E: hth@genmab.com
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