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SemBioSys Genetics Inc. Announces Clinical Results with Plant-Produced Insulin
Date:3/19/2009

    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
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SOURCE SemBioSys Genetics Inc.
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Related biology technology :

1. SemBioSys announces senior management changes
2. SemBioSys receives US$2.5 million from option agreement with MannKind for plant-produced insulin
3. SemBioSys begins phase I/II trial of insulin produced in plant seeds
4. SemBioSys eligible to proceed with Phase I/II plant-produced insulin trial after submission of IND
5. SemBioSys announces second quarter 2008 financial and operational results
6. SemBioSys submits IND for safflower-produced insulin to U.S. FDA
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10. SemBioSys announces first quarter 2008 financial and operational results
11. SemBioSys receives milestone payments from AVAC Ltd.
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