SemBioSys Genetics Inc., a biotechnology company developing protein pharmaceuticals in crop plants, has 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."
"The initiation of the phase I/II clinical trial for plant-produced insulin is a major milestone for SemBioSys. The trial is the first in which plant-produced insulin has been injected into humans and supports the exciting potential for the establishment of plant-produced drugs in the pharmaceutical sector," said Andrew Baum, president and chief executive officer of SemBioSys. "This trial verifies the viability of plant made insulin and defines the regulatory path for plant-made biopharmaceuticals. This trial also represents significant risk reduction for potential large pharmaceutical partners for our insulin and Apo AI Milano programs."
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.
SBS-1000 is human insulin produced from genetically enhanced safflower. SemBioSys has demonstrated that SBS-1000 insulin is physically, structurally and functionally indistinguishable from pharmaceutical-grade human insulin through analytical testing and pre-clinical sub-chronic toxicology studies in rodents and primates.