Summary: Genmab has initiated a Phase I/II safety and dose finding study of
HuMax-CD38 for the treatment of multiple myeloma.
Copenhagen, Denmark; December 7, 2007 - Genmab A/S (OMX: GEN) announced today 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 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);
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. 58/2007
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