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 /PRNewswire-FirstCall/ -- 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 ofatum
|SOURCE Genmab A/S|
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