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news.SemBioSys Genetics has started a toxicology study in animals to demonstrate the safety and comparability of its safflower-produced insulin to pharmaceutical grade human insulin.
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This study is a final key step in the company’s preparations to submit an investigational new drug (IND) application to the 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’s plant system is appropriate to begin human trials.
Andrew Baum, president and CEO of SemBioSys, said: “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.”