Summary: Genmab has amended the design of the ofatumumab pivotal study in
rituximab refractory follicular non-Hodgkin's lymphoma and reduced the number of
patients to approximately 81.
Copenhagen, Denmark; September 27, 2007 - Genmab A/S (OMX: GEN) announced today
it has amended the design of an ongoing pivotal study of ofatumumab
(HuMax-CD20(R)) in rituximab refractory follicular non-Hodgkin's lymphoma (NHL)
to a single arm trial that will now include approximately 81 patients. All
patients will receive one infusion of 300 mg of ofatumumab followed by 7 weekly
infusions of 1000 mg of ofatumumab.
The original study design included 162 patients, who would have received one
infusion of 300 mg of ofatumumab followed by 7 weekly infusions of either 500 or
1000 mg of ofatumumab. This is the first study of ofatumumab dedicated to
patients with rituximab-refractory follicular lymphoma.
In order to establish that ofatumumab is efficacious in this refractory setting,
reducing the number of patients in the trial will help to expedite a result.
The lower dose (500 mg) was dropped to reduce the total number of patients to be
accrued and ensure that these very sick patients receive the maximum dose. Data
from patients who were already treated in the 500 mg dose group will be analyzed
for safety and included in the secondary efficacy analysis, but will not be
included in the primary efficacy analysis.
“This change to the pivotal study design will allow us to treat all the
refractory patients with a higher dose level of ofatumumab, allowing the maximum
opportunity for response and longer lasting effects in this patient population,”
said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is an investigational drug being developed under a co-development and
commercialization agreement between Genmab and GlaxoSmithKline. It is not yet
approved in any market.
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-Inflam(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
HuMax-ZP3(TM); and UniBody(TM) 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. 42/2007
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