Ad-hoc | 6 July 2010 20:08
Genmab A/S /
06.07.2010 20:08
Dissemination of a Adhoc News, transmitted by
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The issuer is solely responsible for the content of this announcement.
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Summary: Genmab announces interim results from a Phase II study of ofatumumab
in RRMS.
Copenhagen, Denmark; July 6, 2010 - Genmab A/S (OMX: GEN) announced today
positive interim results from an ofatumumab Phase II safety and pharmacokinetics
study in patients with relapsing-remitting multiple sclerosis (RRMS).
A total of 38 patients were included in the trial, of which 12 patients received
placebo and 26 patients received ofatumumab intravenously. Patients were treated
with ofatumumab at the dose levels of 100 mg, 300 mg or 700 mg and followed for
24 weeks. There were no dose limiting toxicities, no unexpected safety findings
and the rates of infection were comparable between the groups. Efficacy was
assessed as a secondary endpoint. Although the study included a small number of
patients, statistically significant reductions in the number of brain lesions
(gadolinium-enhancing T1 lesions and new/enlarging T2 lesions) as measured on
serial MRI scans from week 8 to week 24 were seen on ofatumumab as compared to
placebo and the reductions were seen in all dose groups.
'We are encouraged by the first results from this initial Phase II study of
ofatumumab in RRMS, and are looking forward to seeing the full study results
later this year,' said Prof. Jan G.J. van de Winkel, Ph.D., Chief Executive
Officer of Genmab.
About the study
This double blind, randomized, dose-escalation trial includes patients with RRMS
with demonstrated disease activity as evidenced by recent occurrence of relapses
and/or MRI activity. Patients are randomized to receive two infusions of 100
mg, 300 mg or 700 mg of ofatumumab or placebo. After 24 weeks, the patients
randomized to placebo will be treated with ofatumumab and patients who received
ofatumumab will receive placebo. Thus, each patient will receive two
administrations of ofatumumab with 24 weeks follow-up, resulting in a total
treatment period of 48 weeks duration.
The objective of the study is to evaluate the safety of three doses of
ofatumumab in patients with RRMS. The primary endpoints of the study were safety
and pharmacokinetics.
About RRMS
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous
system. MS is twice as common in females as in males, occurs with a peak
incidence at the age of 35 years and incidence varies widely in different
populations and ethnic groups. The etiology of MS remains unknown, but the
geographic variation points towards possible environmental and genetic factors.
The most common form of MS is relapsing-remitting MS characterized by
unpredictable recurrent attacks where the symptoms usually evolve over days and
are followed by either complete, partial or no neurological recovery. No
progression of neurological impairment is experienced between attacks.
About ofatumumab
Ofatumumab is a novel human monoclonal antibody. It targets a part of the CD20
molecule on B-cells encompassing an epitope in the small loop.
Ofatumumab is being developed under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in
any country for RRMS.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery and development teams are using cutting-edge
technology to create and develop products to address unmet medical needs. Our
primary goal is to improve the lives of patients who are in urgent need of new
treatment options. For more information on Genmab's products and technology,
visit www.genmab.com.
This Stock Exchange 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. For a further discussion of these risks, please refer to the section
'Risk Management' in Genmab's Annual Report, which is available on
www.genmab.com. Genmab does not undertake any obligation to update or revise
forward looking statements in this Stock Exchange Release nor to confirm such
statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM);
HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM);
HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM); HuMax-Wnt; HuMax-cMet(TM) and
UniBody(R) are all trademarks of Genmab A/S. Arzerra(R) is a trademark of
GlaxoSmithKline.
Contact: Julia Phillips, Financial Dynamics, T: +44 2072697187; M: +44
7770827263; E: Julia.Phillips@fd.com
Stock Exchange Release no. 25/2010
###
News Source: NASDAQ OMX
06.07.2010 Ad hoc announcement, Financial News and Media Release distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Genmab A/S
Denmark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
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