Genmab's phase 3 pivotal study will evaluate HuMax-CD20 in treatment of common leukemia

By Lisa Kerner

Erie, Pa., May 23 - Genmab A/S said it began a phase 3 pivotal study to evaluate the efficacy and safety of HuMax-CD20 (ofatumumab) in the treatment of refractory B-cell chronic lymphocytic leukemia, the most common leukemia in U.S. adults.

The company received a fast track designation from the Food and Drug Administration for HuMax-CD20 for the same indication in December 2004.

The study will involve approximately 100 chronic lymphocytic leukemia patients who have failed treatment with fludarabine and alemtuzumab or who have failed fludarabine and are intolerant to or ineligible for alemtuzumab, according to a company news release.

Patients in the single arm trial will receive eight weekly infusions of HuMax- CD20, followed by four monthly infusions of HuMax-CD20, Genmab said. At the first infusion, patients will receive 300 mg of HuMax-CD20, and 2,000 mg of HuMax-CD20 at each subsequent infusion.

Genmab will assess disease status at four-week intervals until week 28 and then every three months until disease progression or month 24.

Located in Copenhagen, Genmab creates and develops human antibodies for the treatment of disease.

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