SemBioSys says plant-produced insulin studies show promise

By E. Janene Geiss

Philadelphia, Nov. 28 - SemBioSys Genetics Inc. said Monday that preclinical results of plant-produced insulin from the company's proprietary Stratosome Biologics System show bio-equivalence of purified insulin from arabidopsis seeds when compared with commercial insulin products in an animal model.

Company officials said in a news release they expect that the demand for insulin will continue to increase as the incidence of diabetes increases worldwide and new delivery technologies, like inhaled insulin product Exubera, replace traditional injection methods. Exubera was recently recommended for approval by a U.S. Food and Drug Administration advisory committee.

New delivery methods such as inhaled products use more insulin, officials said.

"We believe that our plant-produced insulin will allow us to supply this expanding market and reduce capital costs by 70% and cost-of-goods by more than 40% compared with current production methods," president and chief executive officer Andrew Baum said in the release.

"Our team has already made substantial progress on the next development objective in this program, which is to achieve commercial levels of insulin expression in safflower, our commercial plant system," he added.

Details of the proof-of-concept study will be published in the January 2006 edition of the Plant Biotechnology Journal.

Using the Stratosome Biologics System, recombinant human insulin was expressed and accumulated in transgenic seed. The system also simplifies the recovery and purification processes, creating significant cost reductions in large-scale production. Insulin tolerance tests demonstrated that the plant-produced insulin was equivalent to commercial sources of human insulin, officials said.

The company has protected its methods for producing insulin in plants through patent applications with the U.S. Patent and Trademark Office and the World Intellectual Property Organization.

Calgary, Alta.-based SemBioSys is a biotechnology company focused on the development, commercialization and production of protein-based pharmaceuticals and non-pharmaceutical products based on its plant genetic engineering skills and proprietary Stratosome Biologics System oilbody-oleosin technology platform.

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