Trial start triggers US$ 15 million milestone from Genentech
LUND, Sweden | March 14, 2011 | BioInvent International AB (STO:BINV) announces today the dosing of the first patient in the phase II study of the Company’s antibody, BI-204. The product candidate is being developed for secondary prevention of cardiovascular events in patients with acute coronary syndrome.
The Phase II study is a multicenter, randomized, double-blind, placebo-controlled study of BI-204, delivered intravenously to patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. The trial will enrol 120 patients at approximately 20 centres in the United States and Canada. It is designed to demonstrate a reduction in plaque inflammation following treatment as quantified by FDG-PET imaging (18F 2-deoxyglucose positron emission tomography).
The antibody is being developed in collaboration with Genentech, a member of the Roche Group (SIX:RO)(SIX:ROG)(OTCQX:RHHBY). BioInvent will receive a milestone payment of US$ 15 million from Genentech upon dosing of the first patient.
Svein Mathisen, CEO of BioInvent, commented: “BI-204 originates from BioInvent’s proprietary n-CoDeR® library and it represents an innovative approach to potentially reducing cardiac events in patients with coronary heart disease. The results from this phase II clinical trial will provide further insights into BI-204’s ability to reduce plaque inflammation and how it potentially can add to current treatment of coronary heart disease.”
About BI-204
BI-204 (anti-oxLDL, MLDL1278A, RG7418) is a human antibody derived from BioInvent’s proprietary antibody library n-CoDeR®.The antibody targets oxidised forms of a lipoprotein (apoB100), which is a component of the LDL particle. LDL is known as “bad cholesterol”. Research in recent years has shown strong links between these oxidised particles and harmful inflammatory processes in the vessel walls. Such inflammation results in the formation of atherosclerotic plaque that may fragment and cause blood clots. Results support that the mechanism behind BI-204 is a modulation of the inflammatory process, resulting in a reduction of pro-inflammatory cells in treated plaques, which in turn leads to a reduction in new plaque formation and the regression of existing plaques. It is being developed as a drug for the secondary prevention of cardiovascular events, such as heart attack or stroke in patients with acute coronary syndrome. BI-204 is being developed in collaboration with Genentech, Inc., a member of the Roche Group.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances to strengthen the product pipeline and increase the likelihood of success. These partners include Genentech, Human Genome Sciences, Roche and ThromboGenics.
The company’s competitive position is underpinned by an in substance patented antibody development platform. The scope and strength of this platform is also utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe, UCB and XOMA.
More information is available at www.bioinvent.com.
SOURCE: BioInvent International AB
Post Views: 55
Trial start triggers US$ 15 million milestone from Genentech
LUND, Sweden | March 14, 2011 | BioInvent International AB (STO:BINV) announces today the dosing of the first patient in the phase II study of the Company’s antibody, BI-204. The product candidate is being developed for secondary prevention of cardiovascular events in patients with acute coronary syndrome.
The Phase II study is a multicenter, randomized, double-blind, placebo-controlled study of BI-204, delivered intravenously to patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. The trial will enrol 120 patients at approximately 20 centres in the United States and Canada. It is designed to demonstrate a reduction in plaque inflammation following treatment as quantified by FDG-PET imaging (18F 2-deoxyglucose positron emission tomography).
The antibody is being developed in collaboration with Genentech, a member of the Roche Group (SIX:RO)(SIX:ROG)(OTCQX:RHHBY). BioInvent will receive a milestone payment of US$ 15 million from Genentech upon dosing of the first patient.
Svein Mathisen, CEO of BioInvent, commented: “BI-204 originates from BioInvent’s proprietary n-CoDeR® library and it represents an innovative approach to potentially reducing cardiac events in patients with coronary heart disease. The results from this phase II clinical trial will provide further insights into BI-204’s ability to reduce plaque inflammation and how it potentially can add to current treatment of coronary heart disease.”
About BI-204
BI-204 (anti-oxLDL, MLDL1278A, RG7418) is a human antibody derived from BioInvent’s proprietary antibody library n-CoDeR®.The antibody targets oxidised forms of a lipoprotein (apoB100), which is a component of the LDL particle. LDL is known as “bad cholesterol”. Research in recent years has shown strong links between these oxidised particles and harmful inflammatory processes in the vessel walls. Such inflammation results in the formation of atherosclerotic plaque that may fragment and cause blood clots. Results support that the mechanism behind BI-204 is a modulation of the inflammatory process, resulting in a reduction of pro-inflammatory cells in treated plaques, which in turn leads to a reduction in new plaque formation and the regression of existing plaques. It is being developed as a drug for the secondary prevention of cardiovascular events, such as heart attack or stroke in patients with acute coronary syndrome. BI-204 is being developed in collaboration with Genentech, Inc., a member of the Roche Group.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances to strengthen the product pipeline and increase the likelihood of success. These partners include Genentech, Human Genome Sciences, Roche and ThromboGenics.
The company’s competitive position is underpinned by an in substance patented antibody development platform. The scope and strength of this platform is also utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe, UCB and XOMA.
More information is available at www.bioinvent.com.
SOURCE: BioInvent International AB
Post Views: 55
