Genmab has completed treatment of 33 patients in a phase I/II dose escalation trial and expanded the study into a phase II trial, which will include 200 additional patients.
In the phase II trial, the patients will be split into four treatment groups. In each group of 50, patients will receive two infusions of 300, 700, or 1000mg doses of HuMax-CD20 or placebo. Patients will be followed for 24 weeks to evaluate safety and efficacy and then every 12 weeks until B-cell counts return to baseline levels.
HuMax-CD20 is a human antibody which is effective at binding to the CD20 molecule on B-cells. In June 2005, Genmab presented positive data from a phase I/II trial with patients with relapsed or refractory follicular lymphoma showing response rates up to 63% in patients treated with HuMax-CD20. A phase I/II trial to treat patients with chronic lymphocytic leukemia is ongoing.