March 26, 2008 - SemBioSys Genetics Inc. (TSX: SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it has initiated a toxicology study in animals to demonstrate the safety and comparability of its safflower-produced insulin to pharmaceutical grade human insulin. This study is a final key step in the Company's preparations to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter in order to initiate a Phase I/II human clinical trial this year. The 28-day repeat dose study in monkeys and rats is the only toxicology study required before submission of the IND application to the FDA. The study is also a required component for the abbreviated 505(b)(2) application process that SemBioSys is eligible to follow, based on the well-characterized nature of insulin. The study aims to establish that the toxicology profile of insulin produced from SemBioSys' plant system is appropriate to begin human trials... SemBioSys Genetics' Press Release -
Friday, March 28, 2008
SemBioSys : toxicology study for safflower-produced insulin
March 26, 2008 - SemBioSys Genetics Inc. (TSX: SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it has initiated a toxicology study in animals to demonstrate the safety and comparability of its safflower-produced insulin to pharmaceutical grade human insulin. This study is a final key step in the Company's preparations to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter in order to initiate a Phase I/II human clinical trial this year. The 28-day repeat dose study in monkeys and rats is the only toxicology study required before submission of the IND application to the FDA. The study is also a required component for the abbreviated 505(b)(2) application process that SemBioSys is eligible to follow, based on the well-characterized nature of insulin. The study aims to establish that the toxicology profile of insulin produced from SemBioSys' plant system is appropriate to begin human trials... SemBioSys Genetics' Press Release -
