Canadian biotech firm SemBioSys has begun UK-based phase I/II trials of its insulin which it produces from genetically-engineered safflower plants.
It represents the first time that the plant-produced insulin has been used on humans with up to 30 healthy volunteers taking part. The trial will compare the efficacy of SemBioSys’ insulin with two commercially-available forms of insulin. SemBioSys says its version is physically, structurally and functionally indistinguishable from ordinary pharmaceutical-grade insulin.
"This sophisticated trial is designed to show bioequivalence with respect to insulin concentrations as well as insulin action on blood glucose,” says SemBioSys acting chief medical officer Bruce Given.
The results of the trial are expected in the first half of 2009.
SemBioSys announced on 24 December 2008 that Mannkind Corporation has bought an option to licence rights for the plant-produced insulin for $2.5m. The deal was expected to close on 5 January 2009. The option period will end on 31 March 2009.
Copyright 2009 Institution of Chemical Engineers
