Summary: Genmab has initiated a Phase II study of HuMax-EGFr in combination
with chemo-radiation to treat non small cell lung cancer.
Copenhagen, Denmark; April 12, 2007 - Genmab A/S (CSE: GEN) announced today it
has initiated a Phase II study of HuMax-EGFr(TM) (zalutumumab) in combination
with chemo-radiation to treat non small cell lung cancer (NSCLC). The study
will include a maximum of 270 previously untreated patients with advanced NSCLC.
“We are excited to expand the HuMax-EGFr program into this new indication and
hope that it may some day prove to be an effective treatment for lung cancer
patients,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the trial
This open label study consists of two parts. Part 1 will include at least 24
patients divided into two sequential treatment groups. Patients in Group A will
receive 2 cycles of induction chemotherapy in combination with weekly fixed
doses of 8 mg/kg of HuMax-EGFr followed by 7 weekly 8 mg/kg doses of HuMax-EGFr
in combination with radiotherapy. Pending satisfactory evaluation of safety
data from Group A, patients in Group B will receive 2 cycles of induction
chemotherapy in combination with HuMax-EGFr at individually titrated doses up to
16 mg/kg, based on the degree of skin rash the patient develops.
This will be followed by 7 weekly doses of HuMax-EGFr in combination with
chemo-radiation.
Safety data from Part 1 of the trial will be evaluated to determine if it is
safe to begin Part 2. There will be two treatment groups in Part 2 of the
study. Patients will receive either 2 cycles of induction chemotherapy in
combination with weekly doses of up to 16 mg/kg of HuMax-EGFr followed by 7
weekly doses of HuMax-EGFr in combination with chemo-radiation or 2 cycles of
induction chemotherapy followed by chemo-radiation alone.
In both parts of the study, patients will be evaluated every 3 months until
disease progression and every 4 weeks thereafter until death in accordance with
the general methodology of trials in cancer patients.
The objective of the study is to evaluate the safety and efficacy of HuMax-EGFr
in combination with chemo-radiation versus chemo-radiation alone in the
treatment of advanced NSCLC. The primary endpoint of the study is progression
free survival from randomization until disease progression or death.
About Non Small Cell Lung Cancer
NSCLC is the leading cause of cancer deaths in both men and women, with
approximately 172,000 patients being diagnosed annually in the US. Almost 25%
of newly diagnosed patients will have advanced (stage IIIA or IIIB) disease for
which effective treatment options are few.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies
for the treatment of life-threatening and debilitating diseases. Genmab has
numerous products in development to treat cancer, infectious disease, rheumatoid
arthritis and other inflammatory conditions, and intends to continue assembling
a broad portfolio of new therapeutic products. At present, Genmab has multiple
partnerships to gain access to disease targets and develop novel human
antibodies including agreements with Roche and Amgen. A broad alliance provides
Genmab with access to Medarex, Inc.'s array of proprietary technologies,
including the UltiMAb(R) platform for the rapid creation and development of
human antibodies to virtually any disease target. In addition, Genmab has
developed UniBody(TM), a new proprietary technology that creates a stable,
smaller antibody format. Genmab has operations in Europe and the US. For more
information about Genmab, 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-EGFr(TM);
HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM), HuMax-CD38(TM);
HuMax-ZP3(TM); and UniBody(TM) are all trademarks of Genmab A/S.
UltiMAb(R) is a trademark of Medarex, Inc.
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. 14/2007
