Copenhagen, Denmark; May 29,
2008 - Genmab A/S (OMX: GEN) reports today 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®) 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™) 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®) in refractory cutaneous T-cell lymphoma
patients.