Genmab announced positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS)
Copenhagen, Denmark | July 6, 2010 | Genmab A/S (OMX: GEN) announced today positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS).
A total of 38 patients were included in the trial, of which 12 patients received placebo and 26 patients received ofatumumab intravenously. Patients were treated with ofatumumab at the dose levels of 100 mg, 300 mg or 700 mg and followed for 24 weeks. There were no dose limiting toxicities, no unexpected safety findings and the rates of infection were comparable between the groups. Efficacy was assessed as a secondary endpoint. Although the study included a small number of patients, statistically significant reductions in the number of brain lesions (gadolinium-enhancing T1 lesions and new/enlarging T2 lesions) as measured on serial MRI scans from week 8 to week 24 were seen on ofatumumab as compared to placebo and the reductions were seen in all dose groups.
“We are encouraged by the first results from this initial Phase II study of ofatumumab in RRMS, and are looking forward to seeing the full study results later this year,” said Prof. Jan G.J. van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study
This double blind, randomized, dose-escalation trial includes patients with RRMS with demonstrated disease activity as evidenced by recent occurrence of relapses and/or MRI activity. Patients are randomized to receive two infusions of 100 mg, 300 mg or 700 mg of ofatumumab or placebo. After 24 weeks, the patients randomized to placebo will be treated with ofatumumab and patients who received ofatumumab will receive placebo. Thus, each patient will receive two administrations of ofatumumab with 24 weeks follow-up, resulting in a total treatment period of 48 weeks duration.
The objective of the study is to evaluate the safety of three doses of ofatumumab in patients with RRMS. The primary endpoints of the study were safety and pharmacokinetics.
About RRMS
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system. MS is twice as common in females as in males, occurs with a peak incidence at the age of 35 years and incidence varies widely in different populations and ethnic groups. The etiology of MS remains unknown, but the geographic variation points towards possible environmental and genetic factors. The most common form of MS is relapsing-remitting MS characterized by unpredictable recurrent attacks where the symptoms usually evolve over days and are followed by either complete, partial or no neurological recovery. No progression of neurological impairment is experienced between attacks.
About ofatumumab
Ofatumumab is a novel human monoclonal antibody. It targets a part of the CD20 molecule on B-cells encompassing an epitope in the small loop.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in any country for RRMS.
SOURCE: Genmab
Post Views: 33
Genmab announced positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS)
Copenhagen, Denmark | July 6, 2010 | Genmab A/S (OMX: GEN) announced today positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS).
A total of 38 patients were included in the trial, of which 12 patients received placebo and 26 patients received ofatumumab intravenously. Patients were treated with ofatumumab at the dose levels of 100 mg, 300 mg or 700 mg and followed for 24 weeks. There were no dose limiting toxicities, no unexpected safety findings and the rates of infection were comparable between the groups. Efficacy was assessed as a secondary endpoint. Although the study included a small number of patients, statistically significant reductions in the number of brain lesions (gadolinium-enhancing T1 lesions and new/enlarging T2 lesions) as measured on serial MRI scans from week 8 to week 24 were seen on ofatumumab as compared to placebo and the reductions were seen in all dose groups.
“We are encouraged by the first results from this initial Phase II study of ofatumumab in RRMS, and are looking forward to seeing the full study results later this year,” said Prof. Jan G.J. van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study
This double blind, randomized, dose-escalation trial includes patients with RRMS with demonstrated disease activity as evidenced by recent occurrence of relapses and/or MRI activity. Patients are randomized to receive two infusions of 100 mg, 300 mg or 700 mg of ofatumumab or placebo. After 24 weeks, the patients randomized to placebo will be treated with ofatumumab and patients who received ofatumumab will receive placebo. Thus, each patient will receive two administrations of ofatumumab with 24 weeks follow-up, resulting in a total treatment period of 48 weeks duration.
The objective of the study is to evaluate the safety of three doses of ofatumumab in patients with RRMS. The primary endpoints of the study were safety and pharmacokinetics.
About RRMS
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system. MS is twice as common in females as in males, occurs with a peak incidence at the age of 35 years and incidence varies widely in different populations and ethnic groups. The etiology of MS remains unknown, but the geographic variation points towards possible environmental and genetic factors. The most common form of MS is relapsing-remitting MS characterized by unpredictable recurrent attacks where the symptoms usually evolve over days and are followed by either complete, partial or no neurological recovery. No progression of neurological impairment is experienced between attacks.
About ofatumumab
Ofatumumab is a novel human monoclonal antibody. It targets a part of the CD20 molecule on B-cells encompassing an epitope in the small loop.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in any country for RRMS.
SOURCE: Genmab
Post Views: 33
