In this study, both SBS-1000 and Humulin(R) R were bioequivalent to Humulin(R) S with respect to total insulin exposure, maximum concentration of insulin and total glucose infused. The only anomalous result from this trial relates to some of the Humulin(R) S data. Neither SBS-1000 nor Humulin(R) R was bioequivalent to Humulin(R) S with respect to the maximum glucose infusion rate. This difference between the two reference standards (Humulin(R) R and Humulin(R) S) was not expected in such a trial and relates, at least in part, to random outliers that occurred in the Humulin(R) S arm and higher overall variability for this endpoint in the trial.
While final analyses regarding safety data are not yet available, the adverse events observed were typical for a study involving recombinant human insulins. The most common events were insulin injection site reactions, pain at the site of glucose infusion, headache and dizziness, with all similar rates of occurrence for both Humulins and SBS-1000. There were no serious adverse events and there were no events indicative of a systemic allergic response to any of the insulins.
"This is the first time one of our plant-derived recombinant proteins has been studied in humans and we were gratified to see that SBS-1000 performed in an equivalent manner to marketed recombinant human insulin with respect to pharmacologic activity and tolerability," said Dr. Maurice Moloney, Chief Scientific Officer and founder of SemBioSys. "We would anticipate that full results of this trial will be submitted to a future scientific conference once all data have been analyzed."
"These results represent a significant milestone for SemBioSys. We have now demonstrated that we can consistently obtain regulatory approval to grow our insulin safflower crops. We have shown that we can extract, purify and formulate insulin from
|SOURCE SemBioSys Genetics Inc.|
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