SemBioSys Begins Phase I/II Clinical Trial of Plant-Produced Insulin

Genetically enhanced safflower producing insulin? That’s what Canada-based biotechnology company SemBioSys Genetics Inc. is developing. The company announced that it has initiated a phase I/II clinical trial of its safflower-derived insulin with the first injection of its drug in humans. The trial will take place in the United Kingdom and will include up to 30 volunteers in a three-arm study. The study aims to demonstrate the bioequivalence of plant-produced insulin to commercially available insulin products. The company expects that results will be available as early as first quarter of 2009.

“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 CEO of SemBioSys. "This trial verifies the viability of plant-made insulin and defines the regulatory path for plant-made biopharmaceuticals.” SemBioSys estimates the world market value for insulin to be in excess of US$7.1 billion today. Demand for insulin is projected to increase due to the growing incidence of diabetes in addition to the expanded use of insulin therapy.

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