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news.SemBioSys Genetics has submitted an investigational new drug application for safflower-produced recombinant human insulin to the FDA.
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The investigational new drug (IND) application contains a physical, chemical and structural analysis of safflower-produced insulin to a reference standard, results from 28-day sub-chronic toxicology studies in two species of mammals, demonstration of pharmacodynamic function in animals and describes a cGMP process for the production of safflower-produced insulin.
SemBioSys plans to initiate a Phase I/II clinical study of its safflower-produced insulin in the fourth quarter of 2008.
SemBioSys also intends to submit a clinical trial application (CTA) to the appropriate European authorities later this quarter. Assuming approval of the CTA, SemBioSys intends to conduct a Phase I/II trial in the UK.
The CTA requests approval to initiate a Phase I/II human clinical trial designed to enroll up to 30 healthy volunteers to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products.
Andrew Baum, president and CEO of SemBioSys, said: “All of our studies to date confirm that our safflower-produced insulin is equivalent to pharmaceutical-grade human insulin. We met our internal schedule to submit the IND and we are on track to begin human clinical trials in the fourth quarter of 2008 as planned.”