BioInvent International AB announced today that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of BI-204, a potential treatment for cardiovascular conditions brought on by atherosclerosis
LUND, Sweden | January 15, 2008 | BioInvent International AB (OMXS: BINV) announced today that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of BI-204, a potential treatment for cardiovascular conditions brought on by atherosclerosis. The trial will be managed by BioInvent and carried out in Denmark, with the first subject expected to be recruited in the study imminently. BioInvent and Genentech, Inc. co-develop BI-204 under an agreement signed in January 2007.
BI-204 is an antibody that targets oxidized forms of the harmful LDL cholesterol (oxLDL) a key component thought to drive the inflammatory processes associated with atherosclerotic plaques. It is being developed as a drug for the secondary prevention of cardiac events, such as heart attack or stroke, in high-risk patients.
The Phase I study is a double-blind, within-group randomised dose-escalation trial testing both single and multiple doses of BI-204 administered either intravenously or subcutaneously. In total, 80 healthy male or female subjects with elevated levels of LDL cholesterol are planned to be included in the trial.
In addition to monitoring the tolerability and safety of BI-204, the study will evaluate pharmacokinetic and pharmacodynamic parameters in order to help set the dosage of BI-204 administered to patients in future Phase II trials.
There are strong links between the levels of the oxidized forms of certain lipoproteins and the inflammatory processes that lead to atherosclerotic plaque formation in blood vessel walls. In preclinical studies, BI-204 was shown to affect inflammatory processes and significantly reduce plaque formation and even cause plaque regression. Plaque regression i.e. reversal of the atherosclerotic process, is at the cutting edge of research in this indication area. The preclinical results suggest that BI-204 may act by modulating inflammatory processes, reducing the number of pro-inflammatory cells in treated plaques. This in turn is thought to lead to a reduction in new plaque formation and the regression of existing plaques.
Svein Mathisen, CEO of BioInvent said: "We are delighted that our collaboration with Genentech, Inc. is progressing well and that as a first sign of this we have received approval from the Danish Medicine´s Agency to take BI-204 into clinical trials. It is good to see BI-204, another n-CoDeR® antibody, enter the clinic as I hope that success in development will offer a unique and significant treatment choice for the clinician and outcomes for the patient."
Legal disclaimer
This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Notes to editors:
BioInvent International AB, listed on The Nordic Exchange (OMXS:BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects within the areas of thrombosis, cancer, atherosclerosis and ophthalmic diseases. In January 2007 the Company announced a major strategic alliance with American-based Genentech, Inc. in the cardiovascular field.
These projects are based on a competitive and in substance patented technology platform. The scope and strength of this platform is also utilised by partners, such as ALK-Abelló, ImmunoGen, OrbusNeich, Sanofi-Aventis, UCB and XOMA.
The Company, which currently has 96 employees, is located at Ideon in Lund.
SOURCE: BIOINVENT
Post Views: 137
BioInvent International AB announced today that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of BI-204, a potential treatment for cardiovascular conditions brought on by atherosclerosis
LUND, Sweden | January 15, 2008 | BioInvent International AB (OMXS: BINV) announced today that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of BI-204, a potential treatment for cardiovascular conditions brought on by atherosclerosis. The trial will be managed by BioInvent and carried out in Denmark, with the first subject expected to be recruited in the study imminently. BioInvent and Genentech, Inc. co-develop BI-204 under an agreement signed in January 2007.
BI-204 is an antibody that targets oxidized forms of the harmful LDL cholesterol (oxLDL) a key component thought to drive the inflammatory processes associated with atherosclerotic plaques. It is being developed as a drug for the secondary prevention of cardiac events, such as heart attack or stroke, in high-risk patients.
The Phase I study is a double-blind, within-group randomised dose-escalation trial testing both single and multiple doses of BI-204 administered either intravenously or subcutaneously. In total, 80 healthy male or female subjects with elevated levels of LDL cholesterol are planned to be included in the trial.
In addition to monitoring the tolerability and safety of BI-204, the study will evaluate pharmacokinetic and pharmacodynamic parameters in order to help set the dosage of BI-204 administered to patients in future Phase II trials.
There are strong links between the levels of the oxidized forms of certain lipoproteins and the inflammatory processes that lead to atherosclerotic plaque formation in blood vessel walls. In preclinical studies, BI-204 was shown to affect inflammatory processes and significantly reduce plaque formation and even cause plaque regression. Plaque regression i.e. reversal of the atherosclerotic process, is at the cutting edge of research in this indication area. The preclinical results suggest that BI-204 may act by modulating inflammatory processes, reducing the number of pro-inflammatory cells in treated plaques. This in turn is thought to lead to a reduction in new plaque formation and the regression of existing plaques.
Svein Mathisen, CEO of BioInvent said: "We are delighted that our collaboration with Genentech, Inc. is progressing well and that as a first sign of this we have received approval from the Danish Medicine´s Agency to take BI-204 into clinical trials. It is good to see BI-204, another n-CoDeR® antibody, enter the clinic as I hope that success in development will offer a unique and significant treatment choice for the clinician and outcomes for the patient."
Legal disclaimer
This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Notes to editors:
BioInvent International AB, listed on The Nordic Exchange (OMXS:BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects within the areas of thrombosis, cancer, atherosclerosis and ophthalmic diseases. In January 2007 the Company announced a major strategic alliance with American-based Genentech, Inc. in the cardiovascular field.
These projects are based on a competitive and in substance patented technology platform. The scope and strength of this platform is also utilised by partners, such as ALK-Abelló, ImmunoGen, OrbusNeich, Sanofi-Aventis, UCB and XOMA.
The Company, which currently has 96 employees, is located at Ideon in Lund.
SOURCE: BIOINVENT
Post Views: 137
