Genmab A/S (OMX: GEN) reports that the last patient to be included
in the planned interim analysis (N=132 patients) in the pivotal Phase III
clinical trial of ofatumumab (HuMax-CD20(R)) in refractory chronic
lymphocytic leukemia (CLL) has now received the last scheduled treatment.
In order to complete the database and allow for assessment of the
responses by an independent committee, the final data will now be collected
and analysed with the results expected in early August 2008. Pending a
positive outcome, a Biologics License application in this indication is
expected to be filed before the end of 2008.
Ofatumumab is an investigational drug being developed to treat CLL,
follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma and
rheumatoid arthritis under a co-development and commercialization agreement
between Genmab and GlaxoSmithKline. It is not yet approved in any country.
Genmab also reported that to date, 132 patients have been dosed in the
pivotal Phase III study of zalutumumab (HuMax-EGFr(TM)) to treat head and
neck cancer patients considered incurable with standard therapy. As
survival is the primary endpoint of this study, a planned interim analysis
will take place based on the survival data for patients participating in the
study. At present, the Company expects this analysis to occur in 2008, but
the exact timing cannot be predicted.
In addition, Genmab announced that based on current recruitment rates,
despite broadening the inclusion criteria, the Company does not expect the
data to be available this year from the ongoing pivotal Phase III study with
zanolimumab (HuMax-CD4(R)) in refractory cutaneous T-cell lymphoma patients.
About Genmab A/S
Genmab is a leading international biotechnology company focused on
developing fully human antibody therapeutics for unmet medical needs. Using
cutting-edge antibody technology, Genmab's world class discovery, development
and manufacturing 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
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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,
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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.
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