Updates on Phase III Studies With Ofatumumab, Zalutumumab and Zanolimumab
COPENHAGEN, Denmark, May 29 /PRNewswire-FirstCall/ -- 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(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 un
|SOURCE Genmab A/S|
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