Summary: Genmab and GlaxoSmithKline have completed recruitment of 66 CLL
patients respectively to both study groups in a pivotal study of ofatumumab.
Copenhagen, Denmark; November 28, 2007 - Genmab A/S (OMX: GEN) announced today
recruitment of 132 patients has been completed in a pivotal study of ofatumumab
(HuMax-CD20(R)) for the treatment of refractory chronic lymphocytic leukemia
(CLL). This cohort comprises 66 patients who are refractory to both fludarabine
and alemtuzumab and 66 fludarabine refractory patients who are considered
inappropriate candidates for alemtuzumab due to bulky tumor in their lymph
nodes. An interim analysis will be conducted on this cohort when 24 week
efficacy data are available. The study will remain open for recruitment in
order to collect additional safety and efficacy data.
Ofatumumab is an investigational, fully human, next generation monoclonal
antibody that targets a unique epitope of the CD20 receptor on the surface of
b-cells. This epitope is different to the other anti-CD20 antibodies currently
available or in development. Ofatumumab is being developed under a
co-development and commercialization agreement between Genmab and
GlaxoSmithKline.
“We look forward to seeing the study results of the interim analysis from both
patient groups. It is our hope, due to the high unmet need amongst these
patients, that registration may be possible in each indication, depending on the
data generated and ongoing discussions with the regulatory authorities.
Recruitment will continue to the trial,” said Lisa N. Drakeman, Ph.D., Chief
Executive Officer of Genmab.
About the study
The study includes CLL patients who are refractory to both fludarabine and
alemtuzumab and patients who are refractory to fludarabine who are considered
inappropriate candidates for alemtuzumab due to bulky tumor in their lymph
nodes. Each group will be analyzed separately and it is hoped that,
registration of ofatumumab may be possible in each indication, depending on the
data generated from this study and the ongoing discussions with the regulatory
authorities.
All patients in the study will receive 8 weekly infusions of ofatumumab,
followed by 4 monthly infusions of ofatumumab. Patients will receive 300 mg of
ofatumumab at the first infusion and 2,000 mg of ofatumumab 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.
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. 56/2007
###
Genmab Announces Update on Recruitment of Patients in Ofatumumab CLL Pivotal Study
| Source: Genmab A/S
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