Summary: Genmab has announced details of a planned Phase II study of ofatumumab
to treat relapsing remitting multiple sclerosis.
Copenhagen, Denmark; December 13, 2007 - Genmab A/S (OMX: GEN) announced today
details of a planned Phase II study of ofatumumab (HuMax-CD20(R)) for the
treatment of relapsing remitting multiple sclerosis (RRMS). Approximately 324
patients will be enrolled in the study which will be conducted under Genmab's
collaboration with GlaxoSmithKline (GSK). The study is expected to begin in the
first quarter of 2008.
Ofatumumab is an investigational, fully human, next generation monoclonal
antibody that targets a unique epitope of the CD20 receptor on the surface of
B-cells. Other anti-CD20 antibodies currently available or in development bind
to a different epitope on the CD20 receptor. Ofatumumab is being developed
under a co-development and commercialization agreement between Genmab and
GlaxoSmithKline.
“Multiple sclerosis is a debilitating disease for which there are currently few
treatments,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
“We hope our fully human antibody, ofatumumab, may offer another potential
treatment option for patients suffering from this incapacitating disease.”
About the trial
The double blind randomized trial will consist of two parts. Part A will
include approximately 36 patients in one of three increasing dose cohorts (100
mg, 300 mg or 700 mg of ofatumumab) randomized to receive ofatumumab or placebo.
An independent data monitoring committee (IDMC) will evaluate the safety of each
sequential cohort prior to progression to the next cohort. When all patients in
Part A have had their week 4 MRI scan, the IDMC will evaluate the data before
Part B of the study begins.
Part B will consist of a 48 week treatment period of approximately 288 patients.
Patients will be randomized to treatment with 100 mg, 300 mg, or 700 mg of
ofatumumab or placebo. After week 24, patients on an active dose will receive
re-treatment with the same dose of ofatumumab or placebo. Patients on placebo
will receive ofatumumab at the highest tolerated dose from Part A.
The objective of the study is to determine the safety and tolerability of three
doses of ofatumumab and the dose response of ofatumumab on disease activity on
MRI in patients with RRMS. The primary endpoints are safety and cumulative
number of new Gd-enhanced lesions from week 8 to week 24.
About Relapsing Remitting Multiple Sclerosis
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 Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for unmet medical needs. Using unique,
cutting-edge antibody technology, Genmab's world class discovery and development
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 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);
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. 60/2007
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Genmab Announces Details of Planned Ofatumumab Phase II Study in Multiple Sclerosis
| Source: Genmab A/S
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