SemBioSys submits IND for safflower-produced insulin to U.S. FDAn

July 29, 2008 - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it has submitted an Investigational New Drug (IND) application for safflower-produced recombinant human insulin to the United States Food and Drug Administration (FDA). The IND application contains a physical, chemical and structural analysis of safflower-produced insulin to a reference standard, results from 28-day sub-chronic toxicology studies in two species of mammals, demonstration of pharmacodynamic function in animals and describes a cGMP process for the production of safflower-produced insulin. SemBioSys plans to initiate a Phase I/II clinical study of its safflower-produced insulin in the fourth quarter of 2008... SemBioSys Genetics' Press Release -

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 -

SemBioSys, insulin data

Oct. 26, 2007 - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it will be presenting a scientific poster and abstract at the Seventh Annual Diabetes Technology Meeting in San Francisco hosted by the Diabetes Technology Society. The poster will disclose SemBioSys' recent accomplishments in the development of a highly-scalable, low-cost source of recombinant human insulin... SemBioSys' Press Release -