LUND, Sweden I 8 November 2016 I BioInvent International (OMXS: BINV) has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma.
BioInvent has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA informed BioInvent that the clinical hold is due to an adverse cardiopulmonary event in the clinical study.
The clinical study is being conducted by BioInvent in collaboration with investigators at the University of Pennsylvania in the United States and aims to document the ability of BI-505 to deepen therapeutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan.
BioInvent will analyse the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report.
Notes to editors:
About BioInvent
BioInvent International AB (OMXS: BINV) is focused on developing a first-in-class and best-in-class pipeline of antibody immunotherapeutics against cancer. The company’s two lead clinical programmes are BI-505, in Phase II development for multiple myeloma, and BI-1206, in Phase I/II for non-Hodgkin’s lymphoma and chronic lymphatic leukaemia. BioInvent also has its own manufacturing facility for the production of antibodies for research through to late-stage clinical trials. The Company has research collaborations with leading academic institutions including Penn Medicine, Cancer Research UK, and the University of Southampton. BioInvent generates revenues from its eight global partnerships, including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma.
SOURCE: BioInvent
Post Views: 166
LUND, Sweden I 8 November 2016 I BioInvent International (OMXS: BINV) has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma.
BioInvent has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA informed BioInvent that the clinical hold is due to an adverse cardiopulmonary event in the clinical study.
The clinical study is being conducted by BioInvent in collaboration with investigators at the University of Pennsylvania in the United States and aims to document the ability of BI-505 to deepen therapeutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan.
BioInvent will analyse the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report.
Notes to editors:
About BioInvent
BioInvent International AB (OMXS: BINV) is focused on developing a first-in-class and best-in-class pipeline of antibody immunotherapeutics against cancer. The company’s two lead clinical programmes are BI-505, in Phase II development for multiple myeloma, and BI-1206, in Phase I/II for non-Hodgkin’s lymphoma and chronic lymphatic leukaemia. BioInvent also has its own manufacturing facility for the production of antibodies for research through to late-stage clinical trials. The Company has research collaborations with leading academic institutions including Penn Medicine, Cancer Research UK, and the University of Southampton. BioInvent generates revenues from its eight global partnerships, including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma.
SOURCE: BioInvent
Post Views: 166
