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Initiation of study puts company on track for Phase I/II trial
CALGARY, Canada | March 26, 2008 | SemBioSys Genetics Inc. (TSX: SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it has initiated a toxicology study in animals to demonstrate the safety and comparability of its safflower-produced insulin to pharmaceutical grade human insulin. This study
is a final key step in the Company's preparations to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter in order to initiate a Phase I/II human clinical trial this year. The 28-day repeat dose study in monkeys and rats is the only toxicology study required before submission of the IND application to the FDA. The study is also a required component for the abbreviated 505(b)(2) application process that SemBioSys is eligible to follow, based on the well-characterized nature of insulin. The study aims to establish that the toxicology profile of insulin produced from SemBioSys' plant system is appropriate to begin human trials.
"Insulin is currently one of the largest volume recombinant biopharmaceutical products on the market and demand is projected to increase dramatically in the coming years. The scalability of our safflower-produced insulin has the potential to provide a cost-effective source of insulin to
meet this growing demand," said Andrew Baum, President and CEO of SemBioSys. "In order to start the toxicology study we had to demonstrate that our safflower-produced insulin is chemically, physically and structurally equivalent to human insulin using a broad array of assays. The toxicology
study is an important milestone for our insulin program and demonstrates that we are on track to begin human clinical trials in the second half of 2008."
SemBioSys has already established that safflower-produced insulin is physically, structurally and physiologically indistinguishable from pharmaceutical-grade human recombinant insulin in laboratory testing. In a standard quantitative blood sugar assay performed in rabbits (insulin
tolerance test), SemBioSys has demonstrated the pharmacodynamic equivalence of safflower-produced insulin to pharmaceutical-grade insulin. Thus the completion of this toxicology study fulfills the pre-requisite for filing the IND.
The world market for insulin is US$7.1 billion today and the demand for insulin is projected to increase due to two factors. Demographic and dietary choices in the western world are causing an increase in the incidence of diabetes. At the same time, countries in the rest of the world, that are
currently underserved in the insulin market, are demanding greater access to insulin at an affordable price. By 2012, independent estimates predict a US$15 billion insulin market. SemBioSys' plant-made insulin will offer dramatic capital and operating cost reductions with the potential to enter the market as a low-cost source of insulin to meet this exploding demand.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company's lead pharmaceutical candidates, produced in the plant host safflower, are recombinant human insulin to serve the rapidly expanding global diabetes market and Apo AI, a next generation cardiovascular drug. In addition to its pharmaceutical products, SemBioSys is developing a series of non-pharmaceutical products addressing human topical, nutritional oils and agricultural biotechnology markets.
SOURCE: SemiBioSys Genetics Inc.
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