Plant-Produced Insulin Equivalent to Commercial Insulin
January 12, 2007| |
The safflower-produced insulin by the biotech company SemBioSys Genetics, Inc. has been confirmed through analytical, in vitro and in vivo assays to be chemically, structurally and functionally equivalent to U.S. pharma grade human insulin. The results from the equivalence testing are the most recent achievement for the insulin program.
"As a result of these achievements we expect that we will be able to submit an Investigational New Drug Application (IND) later this year and initiate a Pharmacokinetic/ Pharmacodynamic study of safflower-produced insulin late in the fourth quarter of 2007 or early in the first quarter of 2008, leading to an end of Phase II meeting with the FDA in 2008", said Andrew Baum, President and CEO of the company. Insulin is used for the treatment of diabetes, and demand for high quality insulin is projected to increase to 16,000 kilograms by 2012.
The news article is available at http://www.sembiosys.com/news2.aspx?id=5295&secId=7.
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