Download genmab initiates humax-cd20 cll pivotal study

Genmab A/S
Toldbodgade 33
1253 Copenhagen K
Denmark
Tel + 45 7020 2728
Fax + 45 7020 2729
CVR no. 2102 3884
Contact:
Helle Husted
Director, Investor Relations
T: +45 33 44 77 30
M: +45 25 27 47 13
E: [email protected]
GENMAB INITIATES HUMAX-CD20 CLL PIVOTAL STUDY
Summary: Genmab has initiated a Phase III pivotal study in HuMax-CD20 to treat CLL
patients failing available therapies.
Copenhagen, Denmark; May 23, 2006 – Genmab A/S (CSE: GEN) announced today it
has initiated a Phase III pivotal study with HuMax-CD20™ (ofatumumab) to treat
patients with refractory B-cell Chronic Lymphocytic Leukemia (CLL). HuMax-CD20
received a Fast Track designation from the FDA in December 2004 for this indication.
The study will include approximately 100 CLL patients who have failed treatment with
fludarabine and alemtuzumab or who have failed fludarabine and are intolerant to or
ineligible for alemtuzumab.
“We are excited to begin the pivotal study for HuMax-CD20 in Chronic Lymphocytic
Leukemia,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We
hope HuMax-CD20 will become a new alternative to CLL patients who do not respond to
currently available therapies.”
About the trial
Patients in the single arm trial will receive 8 weekly infusions of HuMax-CD20, followed
by 4 monthly infusions of HuMax-CD20. Patients will receive 300 mg of HuMax-CD20
at the first infusion and 2,000 mg of HuMax-CD20 at each subsequent infusion. Disease
status will be assessed every 4 weeks until week 28 and then every 3 months until disease
progression or month 24.
The objective of the study is to evaluate the efficacy and safety of HuMax-CD20 and the
primary endpoint is objective response over a 24 weeks period from start of treatment.
The responses will be assessed by an Independent Endpoints Review Committee
according to the National Cancer Institute Working Group guidelines.
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About CLL
CLL is the most common leukemia in adults in the US and most of Western Europe. The
incidence is 8,100 to 12,500 new cases in the US per year and 85-95% of the cases are of
B-cell origin. CLL is a subgroup of non-Hodgkin’s lymphoma (NHL) and together with
small lymphocytic lymphoma (SLL) corresponds to around 20% of all NHL cases.
Conference Call
Genmab will hold a conference call to discuss the news tomorrow, Wednesday, May 24,
2006 at:
3.30 pm CEST
2.30 pm BST
9.30 am EDT
The dial in numbers are as follows:
+1 800 406 5356 (in the US) and ask for the Genmab conference call
+1 913 981 5572 (outside the US) and ask for the Genmab conference call
The conference call will be held in English.
International Non-proprietary Name (INN)
Ofatumumab has reached the status of recommended INN, which is the international nonproprietary name (generic name) for HuMax-CD20, as adopted by WHO.
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,
Amgen and Serono. A broad alliance provides Genmab with access to Medarex, Inc.'s
array of proprietary technologies, including the UltiMAb® platform for the rapid creation
and development of human antibodies to virtually any disease target. Genmab has
operations in Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New
Jersey in 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
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GENMAB INITIATES HUMAX-CD20 CLL PIVOTAL STUDY
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®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD4®; HuMax-EGFr™; HuMax-Inflam™;
HuMax-CD20™; HuMax-TAC™; HuMax-HepC™ and HuMax-CD38™ are all trademarks of Genmab
A/S.
UltiMAb® is a trademark of Medarex, Inc.
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