Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 previously untreated follicular non-Hodgkin’s lymphoma (NHL) patients in the Phase II study of ofatumumab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)
Copenhagen, Denmark | September 22, 2008 | Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 previously untreated follicular non-Hodgkin’s lymphoma (NHL) patients in the Phase II study of ofatumumab (HuMax-CD20®) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP).
"We are happy to finish enrolment in this first study with ofatumumab in front line follicular NHL patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer at Genmab. "We look forward to seeing the results of this trial."
Ofatumumab is an investigational, new generation, human monoclonal antibody that targets a distinct membrane proximal, small loop epitope (specific binding site) of the CD20 molecule on the surface of B-cells. 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 for sale in any country.
About the trial
Patients in this open label study were randomized into two dose groups of 28 patients each and receive a total of 6 infusions of ofatumumab in combination with CHOP. Each patient will receive 300 mg of ofatumumab at the first infusion, followed by 5 subsequent infusions of either 500 or 1000 mg of ofatumumab every 3 weeks, in combination with 6 cycles of CHOP. Disease status will be assessed at three months following the last treatment and then every three months until month 24, and every 6 months thereafter until 60 months or initiation of alternative treatment.
The objective of the study is to determine the efficacy of two dose regimens of ofatumumab in combination with CHOP in previously untreated follicular NHL patients. The primary endpoint in the study is objective response from start of treatment until 3 months after last administration of ofatumumab assessed according to the standardized response criteria for NHL.
SOURCE: Genmab
Post Views: 95
Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 previously untreated follicular non-Hodgkin’s lymphoma (NHL) patients in the Phase II study of ofatumumab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)
Copenhagen, Denmark | September 22, 2008 | Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 previously untreated follicular non-Hodgkin’s lymphoma (NHL) patients in the Phase II study of ofatumumab (HuMax-CD20®) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP).
"We are happy to finish enrolment in this first study with ofatumumab in front line follicular NHL patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer at Genmab. "We look forward to seeing the results of this trial."
Ofatumumab is an investigational, new generation, human monoclonal antibody that targets a distinct membrane proximal, small loop epitope (specific binding site) of the CD20 molecule on the surface of B-cells. 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 for sale in any country.
About the trial
Patients in this open label study were randomized into two dose groups of 28 patients each and receive a total of 6 infusions of ofatumumab in combination with CHOP. Each patient will receive 300 mg of ofatumumab at the first infusion, followed by 5 subsequent infusions of either 500 or 1000 mg of ofatumumab every 3 weeks, in combination with 6 cycles of CHOP. Disease status will be assessed at three months following the last treatment and then every three months until month 24, and every 6 months thereafter until 60 months or initiation of alternative treatment.
The objective of the study is to determine the efficacy of two dose regimens of ofatumumab in combination with CHOP in previously untreated follicular NHL patients. The primary endpoint in the study is objective response from start of treatment until 3 months after last administration of ofatumumab assessed according to the standardized response criteria for NHL.
SOURCE: Genmab
Post Views: 95
