Genmab's HuMax-CD38 Enters Phase I/II Clinical Trial For Multiple Myeloma

Genmab A/S
(OMX: GEN) announced it has initiated a Phase I/II safety and dose
finding study of HuMax-CD38(TM) for the treatment of multiple myeloma (MM).
The study will include a maximum of 122 patients with MM who are relapsed
or refractory to at least two different prior treatments and are without
further established treatment options.


"HuMax-CD38 is the ninth Genmab antibody to enter clinical
development," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab. "We are looking forward to the results of this safety study and
hope that HuMax-CD38 may one day offer a new potential treatment for
multiple myeloma patients who have run out of treatment options."



About the trial



This open label dose escalation safety study will consist of two parts.
In Part 1, 26 to 62 patients will be enrolled depending on the number of
dose levels reached during escalation. Patients in Part 1 will be divided
into cohorts at various doses of HuMax-CD38, with each patient receiving 7
infusions. The first infusion will be followed by a 3 week period of safety
monitoring with the following 6 doses to be given at weekly intervals.



In Part 2, 60 patients will be enrolled with 20 patients in each of
three dose levels. The highest dose in Part 2 will be the highest safe dose
in Part 1 and two dose levels below. Patients in Part 2 will receive 6
infusions of HuMax-CD38 at weekly intervals.



In each part of the study, patients will attend 12 follow up visits at
2 to 4 week intervals to assess safety and efficacy and will be followed
every 12 weeks thereafter until disease progression, initiation of
alternative treatment for MM or death for a maximum total of 2 years from
study start.



About HuMax-CD38



HuMax-CD38 is a fully human antibody that targets the CD38 molecule
which is highly expressed on the surface of multiple myeloma tumor cells.
In preclinical studies, HuMax-CD38 was more effective in triggering the
immune system killing mechanisms Antibody-Dependent Cellular Cytotoxicity
(ADCC) and Complement Dependent Cytotoxicity (CDC), than other human CD38
antibodies when tested on multiple myeloma tumors. HuMax-CD38 also potently
killed tumor cells from a patient with a CD38/138 positive plasma cell
leukemia which was refractory to chemotherapy at the time of analysis.
Furthermore, treatment with HuMax-CD38 slowed tumor growth in both
preventive and therapeutic settings in SCID mice in animal models.
HuMax-CD38 is the first antibody known to block the ecto-enzymatic activity
of CD38.



About Multiple Myeloma



Multiple Myeloma is a plasma cell disorder, characterized by
uncontrolled and progressive proliferation of a plasma cell clone. The
proliferation of myeloma cells causes displacement of the normal bone
marrow. MM accounts for approximately 1% of all malignancies and 10% of all
hematologic malignancies with a higher frequency in African Americans where
MM accounts for 20% of all hematologic malignancies. In the US,
approximately 11,000 deaths each year are related to MM and the estimated
number of new cases is rising. At present, no cure is available, and the
mean survival is approximately 3-5 years.
















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 genmab.



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.


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