SemBioSys begins phase I/II trial of insulin produced in plant seeds
SemBioSys Genetics Inc. announced that it has initiated a phase I/II clinical trial of its plant-produced insulin with the first injection of its drug in humans. The trial, taking place in the United Kingdom (UK), will include up to 30 healthy volunteers in a three-arm study (SBS-1000 insulin and two commercial standards) to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products. Full results are expected to be available during the first half of 2009.
"We have commenced the planned phase I/II clinical trial with plant-made insulin. This is the largest volume biopharmaceutical ever produced in plants," stated Bruce Given, M.D., acting chief medical officer at SemBioSys. "This sophisticated trial is designed to show bioequivalence with respect to insulin concentrations as well as insulin action on blood glucose. Bioequivalence is being measured by comparing SBS-1000 to commercially available insulin currently used to treat diabetes."
SemBioSys prepared the clinical material in its Current Good Manufacturing Practice (cGMP) compliant manufacturing plant, which underwent a successful cGMP inspection as required by European Union (EU) regulations. Successful completion of this clinical trial in Europe should contribute to the satisfaction of regulatory requirements in Europe and North America. Both the United States and European regulatory authorities have confirmed that SBS-1000 insulin is eligible to receive approval through an abbreviated regulatory path.
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