Summary: Genmab has initiated a Phase I/II study of zalutumumab in combination
with irinotecan chemotherapy to treat refractory colorectal cancer patients.
Copenhagen, Denmark; May 30, 2008 - Genmab A/S (OMX: GEN) announced today it has
initiated a Phase I/II study of zalutumumab (HuMax-EGFr(TM)) in combination with
irinotecan chemotherapy to treat colorectal cancer (CRC). The study will
include a maximum of 97 patients who have failed standard chemotherapy and
progressed during or within three months of stopping cetuximab-based therapy.
“We are glad to expand the zalutumumab program with this new indication,” said
Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the trial
This open label study consists of two parts. In both parts of the study,
patients will receive weekly doses until disease progression. Part 1 will
include 3 to 15 patients who will receive weekly doses of first 8mg/kg of
zalutumumab in combination with bi-weekly irinotecan and if safe patients will
subsequently receive 16 mg/kg zalutumumab in combination with irinotecan.
Part 2 will be an open label randomized parallel group enrolling 14 to 82
patients pending the number of treatment arms and early termination from part 1.
Patients in part 2 will receive weekly doses of zalutumumab with or without
bi-weekly irinotecan administration until disease progression. In total a
maximum of 97 patients will be enrolled into the study.
Safety data from Part 1 of the trial will be evaluated by an independent data
monitoring committee who will determine if it is safe to begin Part 2. The
objective of the study is to evaluate the safety and efficacy of zalutumumab in
combination with irinotecan. The primary endpoint of the study is adverse
events.
About Colorectal Cancer
CRC is a public health problem in developed countries. Although potentially
curable in early stages, a proportion of patients will present with or
eventually develop metastatic, incurable disease.
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 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. 25/2008
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