Initiation of study puts company on track for Phase I/II trial
TSX symbol: SBS
CALGARY, March 26 /PRNewswire-FirstCall/ - 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
|SOURCE SemBioSys Genetics Inc.|
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