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 -
Monday, August 11, 2008
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 -
