SBS-1000 shown to be bioequivalent to Humulin(R) R (recombinant human insulin)
CALGARY, March 19 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), specializing in the manufacture of high-value proteins and oils in plant seeds, today announced preliminary results of its first "in-man" clinical study of SBS-1000, a recombinant human insulin manufactured using its proprietary platform. The trial demonstrated that SBS-1000 was bioequivalent to a recombinant human insulin with the expected safety profile.
Highlights from the preliminary analysis were: - SBS-1000 was bioequivalent to Eli Lilly's Humulin(R) R, a widely-used human insulin in North America, meeting all four of the endpoints outlined below. - SBS-1000 in humans showed pharmacokinetics and pharmacodynamics indistinguishable from Eli Lilly's Humulin(R) R, as SemBioSys had previously shown in animals. - SBS-1000 was well tolerated at pharmacologically active dosages.
In this single administration, double blind trial, 23 healthy volunteers were administered the same dose of SBS-1000, Humulin(R) R (recombinant human insulin marketed in the US by Eli Lilly) and Humulin(R) S (recombinant human insulin marketed in the UK by Eli Lilly) in a three way cross-over study. This euglycemic clamp study coupled insulin administration with glucose infusion to maintain the volunteers' blood sugars at baseline levels.
Preliminary data are available for the primary endpoints of 1) total insulin exposure, calculated from the measured blood levels for insulin for eight hours post-injection (AUC(insulin0to8hrs)); 2) maximum concentration of insulin (Cmax(insulin)); 3) total glucose infused over eight hours (AUC(GIR0to8hrs)); and 4) maximum glucose infusion rate (GIR(max)). Bioequivalence is declared when the comparisons between two products indicate that statistically the
|SOURCE SemBioSys Genetics Inc.|
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