Genmab announced today it has completed recruitment of 56 patients in the Phase II study of ofatumumab (HuMax-CD20(R)) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients
Copenhagen, Denmark | July 9, 2008 | Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 patients in the Phase II study of ofatumumab (HuMax-CD20(R)) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
"We are pleased to complete patient enrollment in the first front line study of ofatumumab and hope to see a positive outcome for the CLL patients in this trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is an investigational fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 molecule on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 molecule. Ofatumumab is being developed to treat CLL, follicular non-Hodgkin’s lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
About the trial
Patients in this open label study will be randomized into two treatment groups of 28 patients each. Each patient will receive 6 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status will be measured every 4 weeks until week 24 according to National Cancer Institute Working Group Guidelines and every 3 months thereafter until disease progression or 24 months. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 48 months.
The objective of the study is to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary endpoint is complete remission measured at any time during the treatment period.
SOURCE: Genmab A/S
Post Views: 92
Genmab announced today it has completed recruitment of 56 patients in the Phase II study of ofatumumab (HuMax-CD20(R)) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients
Copenhagen, Denmark | July 9, 2008 | Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 patients in the Phase II study of ofatumumab (HuMax-CD20(R)) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
"We are pleased to complete patient enrollment in the first front line study of ofatumumab and hope to see a positive outcome for the CLL patients in this trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is an investigational fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 molecule on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 molecule. Ofatumumab is being developed to treat CLL, follicular non-Hodgkin’s lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
About the trial
Patients in this open label study will be randomized into two treatment groups of 28 patients each. Each patient will receive 6 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status will be measured every 4 weeks until week 24 according to National Cancer Institute Working Group Guidelines and every 3 months thereafter until disease progression or 24 months. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 48 months.
The objective of the study is to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary endpoint is complete remission measured at any time during the treatment period.
SOURCE: Genmab A/S
Post Views: 92
