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Safflower-based insulin OK for human trials

A Calgary biotech company using modified safflowers to make insulin for diabetes treatments has clearance from U.S. regulators to take its product to human clinical trials.

SemBioSys Genetics announced Tuesday that it’s now eligible to go ahead with its planned Phase I/II human clinical trial of plant-produced insulin, since the 30-day review period of its investigational new drug (IND) application before the U.S. Food and Drug Administration (FDA) has passed.

SemBioSys said it plans to conduct the Phase I/II insulin trial in Europe, but filed an IND in the U.S. to make sure it could pursue U.S. and European approvals at the same time.

“Conducting the planned insulin trial in Europe
allows us to establish the bioequivalence of our safflower-produced insulin to commercially available insulin products from both the U.S. and Europe in a single trial,” SemBioSys CEO Andrew Baum said in a release.

However, before it goes ahead with a planned trial in the U.K., the company’s clinical trial application (CTA) must be reviewed by European regulatory authorities.

Pending that approval, the company plans to go ahead with trials in the fourth quarter of this year. The trial is designed to enroll up to 30 healthy volunteers in a three-arm study to show the equivalence of safflower-produced insulin to products now on the market.

The company said both European and U.S. regulators have indicated that the product, if successful in trials, would then be eligible for approval through an “abbreviated” process.

“Our recent accomplishments confirm our confidence in our regulatory and
development strategy using plants as a low-cost production host for insulin,” Baum said.

“Plant-produced human recombinant insulin represents a major step forward in insulin production. We believe, furthermore, that these upcoming studies could prove to be the greatest achievement in insulin production since the advent of recombinant human insulin in the early ’80s.”

The global insulin market is currently worth over US$7.1 billion, the company said, and the demand for insulin is projected to increase, due to both the growing incidence of diabetes and the expanded
use of insulin therapy. As a result, insulin demand is expected to nearly double over the next five years and boost the global insulin market to over US$15 billion by 2012.

SemBioSys is also using its safflower lines as a factory to make what it hopes will be commercial levels of “Apo AI,” a major protein in HDL (“good” cholesterol). The company has said it hopes to have that product in clinical trials next year.

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