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Genmab A/S announced today that study centers have been initiated and are ready to enroll patients in a Phase II study of ofatumumab (HuMax-CD20®) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant
COPENHAGEN, Denmark | December 13, 2007 | Genmab A/S (OMX:GEN) announced today that study centers have been initiated and are ready to enroll patients in a Phase II study of ofatumumab (HuMax-CD20®) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant. Approximately 75 patients will be enrolled in the study which is being conducted under Genmab’s collaboration with GlaxoSmithKline (GSK). Genmab will receive a milestone payment of approximately DKK 87.2 million from GSK upon treatment of the first patient in the study, expected in the near future.
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. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
“We have now expanded the ofatumumab clinical development program into a fourth disease area,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We hope ofatumumab will offer a new and effective treatment option for patients suffering from DLBCL.”
About the trial
In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of 24 months after treatment start according to the “Revised response criteria for malignant lymphoma.” After 24 months, patients will be followed until initiation of alternative DLBCL treatment or month 60. The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a 6 month period from start of treatment.
About Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma is a cancer of the B-lymphocytes and represents 30% of non-Hodgkin’s lymphomas in adults and is the most common lymphoid malignancy in the western world. There are an estimated 63,000 new cases of DLBCL diagnosed in the per year. The median age at diagnosis is about 65 years.
SOURCE: Genmab |
