- Submission demonstrates progress of plant-derived insulin program

scheduled to enter the clinic later this year -

TSX symbol: SBS

CALGARY, July 29 /CNW/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it has submitted an Investigational New Drug (IND) application for safflower-produced recombinant human insulin to the United States Food and Drug Administration (FDA). The 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.

"The submission of the IND is a critical step toward the initiation of a Phase I/II clinical trial with our recombinant human insulin produced from safflower. 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," said Andrew Baum, president and chief executive officer of SemBioSys. "While we intend to initiate our first clinical trial for insulin in the UK, a successful IND application will provide us with the opportunity to consult the FDA on later stage clinical development. We believe this will allow us to apply for European and U.S. approvals for our safflower-produced insulin simultaneously."

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. After discussions with the FDA in late 2006, SemBioSys was informed that safflower-produced insulin is eligible to receive approval through an abbreviated 505(b)(2) regulatory path.