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Insulin Produced by SafflowerCALGARY - Jul 19/06 - SNS -- Commercially viable levels of insulin were produced by a safflower plant genetically modified by the biotechnology firm, SemBioSys Genetics Inc., to produce the human form of the protein. The latest trials saw insulin production in the seed reach 1.2% of total seed protein, slightly better than the company's target of 1%. "These results demonstrate that we have produced an authentic insulin molecule in safflower at commercially viable levels. Achieving our goal of one percent insulin accumulation in safflower confirms that SemBioSys has the potential to dramatically impact the economics of insulin manufacturing," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "At these levels we can produce over one kilogram of insulin per acre of safflower production, which is enough to supply 2,500 patients for one year of treatment. We believe that we could meet the world's total projected insulin demand in 2010 with less than 16,000 acres of crop production. Our plan is to continue to scale-up production for sufficient material to initiate clinical trials and file an Investigational New Drug (IND) application in the second half of 2007." SemBioSys intends to continue its preclinical program with safflower-derived insulin and assemble the components of its IND application including toxicology, immunology profiles and demonstration of efficacy in animal models. The Company expects to be in a position to submit an IND to the U.S. Food and Drug Administration in the second half of 2007 in preparation for a clinical trial in late 2007 or early 2008. The company asserts safflower-produced insulin can reduce capital costs compared to existing insulin manufacturing by 70% and product costs by 40%. It estimates it would cost $80 million to produce 1,000 kilograms of insulin from genetically modified safflower, versus $250 million with the fermentation process now in use.
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