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Phase III trials (ASCLEPIOS I and II) with the subcutaneous formulation of ofatumumab in Relapsing Multiple Sclerosis
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Studies expected to begin enrolling in September 2016
COPENHAGEN, Denmark I June 2, 2016 I Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its collaboration partner Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrolment of patients expected to start in September 2016. The studies will compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS. Details of the studies will shortly become available on clinicaltrials.gov.
“Ofatumumab has the potential to be a best-in-class anti B-cell therapy for relapsing MS,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to swift execution and outcome of these trials and to further development of ofatumumab in this disease area.”
About the ASCLEPIOS I and II studies
The Phase III trials are randomized, double-blind, double-dummy studies comparing the efficacy and safety of subcutaneous ofatumumab versus teriflunomide, a standard treatment in MS, in approximately 900 patients with relapsing MS per study. Patients will be randomized to receive either subcutaneous injections of ofatumumab every four weeks or of teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo). The primary endpoint of the studies is annualized relapse rate (ARR), which is the number of confirmed relapses in a 12 month period. The studies will be conducted by Novartis.
About Multiple Sclerosis
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system that affects approximately 2.5 million people worldwide.1 MS is twice as common in females as in males, occurring with a peak incidence at the age of 30 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. Relapsing MS is characterized by unpredictable recurrent attacks and accounts for 80% of MS cases.2
About Ofatumumab
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes.
Ofatumumab is approved and marketed for intravenous use in certain chronic lymphocytic leukemia indications under the trade name Arzerra(r). Please see full Prescribing Information, including Boxed WARNING for Arzerra.
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis also has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.
Ofatumumab is not approved anywhere in the world as a treatment for relapsing MS.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, Arzerra(r) (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX(r) (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin’s lymphoma. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies – the DuoBody(r) platform for generation of bispecific antibodies, and the HexaBody(r) platform which creates effector function enhanced antibodies. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
SOURCE: Genmab
Post Views: 112
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Phase III trials (ASCLEPIOS I and II) with the subcutaneous formulation of ofatumumab in Relapsing Multiple Sclerosis
-
Studies expected to begin enrolling in September 2016
COPENHAGEN, Denmark I June 2, 2016 I Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its collaboration partner Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrolment of patients expected to start in September 2016. The studies will compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS. Details of the studies will shortly become available on clinicaltrials.gov.
“Ofatumumab has the potential to be a best-in-class anti B-cell therapy for relapsing MS,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to swift execution and outcome of these trials and to further development of ofatumumab in this disease area.”
About the ASCLEPIOS I and II studies
The Phase III trials are randomized, double-blind, double-dummy studies comparing the efficacy and safety of subcutaneous ofatumumab versus teriflunomide, a standard treatment in MS, in approximately 900 patients with relapsing MS per study. Patients will be randomized to receive either subcutaneous injections of ofatumumab every four weeks or of teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo). The primary endpoint of the studies is annualized relapse rate (ARR), which is the number of confirmed relapses in a 12 month period. The studies will be conducted by Novartis.
About Multiple Sclerosis
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system that affects approximately 2.5 million people worldwide.1 MS is twice as common in females as in males, occurring with a peak incidence at the age of 30 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. Relapsing MS is characterized by unpredictable recurrent attacks and accounts for 80% of MS cases.2
About Ofatumumab
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes.
Ofatumumab is approved and marketed for intravenous use in certain chronic lymphocytic leukemia indications under the trade name Arzerra(r). Please see full Prescribing Information, including Boxed WARNING for Arzerra.
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis also has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.
Ofatumumab is not approved anywhere in the world as a treatment for relapsing MS.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, Arzerra(r) (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX(r) (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin’s lymphoma. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies – the DuoBody(r) platform for generation of bispecific antibodies, and the HexaBody(r) platform which creates effector function enhanced antibodies. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
SOURCE: Genmab
Post Views: 112
