SemBioSys Genetics Inc. Announces Clinical Results with Plant-Produced Insulin

SBS-1000 shown to be bioequivalent to Humulin(R) R (recombinant human
    insulin)CALGARY, March 19 /CNW/ - 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 there is confidence that the two products fall within a
range of 80-125% of one another for each variable.
    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 plant seeds to USP and EP standards and finally, we
have obtained regulatory approval in the US and Europe to administer SBS 1000
in a phase I/II clinical trial, where our insulin was been found to be
biologically active without any unexpected adverse reactions," commented James
Szarko, Chief Executive Officer at SemBioSys. "We are continuing optimization
work targeted at streamlining the production process to further improve cost
of goods."

    About SemBioSys

    Calgary, Alberta-based SemBioSys is a world leader in manufacturing
high-value proteins and oils in plant seeds. With its unique, proprietary
platform, SemBioSys provides partners with product enablement, exceptionally
low cost and unprecedented scalability. The Company applies this platform with
high selectivity to opportunities where it has a unique competitive advantage.
Since its inception, SemBioSys has produced more than 50 non-native proteins
and oils using its patented seed technology, demonstrating applicability
across a broad range of industries such as pharmaceuticals, personal care and
industrial products. The Company's current pharmaceutical development programs
include insulin (SBS-1000, regulated as a biosimilar in Europe) and Apo
AI(Milano), a next-generation cardiovascular therapy. SemBioSys is listed on
the Toronto Stock Exchange under the ticker SBS. More information is available
at www.sembiosys.com.

    This press release contains certain forward-looking statements,
including, without limitation, statements containing the words "believe",
"may", "plan", "will", "estimate", "continue", "anticipate", "intend",
"expect" and other similar expressions which constitute "forward-looking
information" within the meaning of applicable securities laws. Forward-looking
statements reflect the Company's current expectation and assumptions, and are
subject to a number of risks and uncertainties that could cause actual results
to differ materially from those anticipated. These forward-looking statements
involve risks and uncertainties including, but not limited to, changing market
conditions and market size, the acceptance of an IND by the FDA in respect of
clinical studies, the submission of a CTA to the appropriate European
authorities, the successful initiation and timely and successful completion of
clinical studies, the fact that Apo AI(Milano) is currently a development
stage drug, the establishment of corporate alliances, the impact of
competitive products and pricing, new product development, uncertainties
related to the regulatory approval process and other risks detailed from
time-to-time in the Company's ongoing filings with the Canadian securities
regulatory authorities which filings can be found at www.sedar.com. Given
these risks and uncertainties, readers are cautioned not to place undue
reliance on such forward-looking statements. The Company undertakes no
obligation to publicly update or revise any forward-looking statements either
as a result of new information, future events or otherwise, except as required
by applicable Canadian securities laws.

For further information: SemBioSys Genetics Inc.: Abby Garfunkel,
Investor Relations, Phone: [phone], E-mail: [e-mail];
The Trout Group: Christine Labaree, Managing Director, Phone: [phone],
E-mail: [e-mail]; The Equicom Group Inc.: Ross Marshall, Vice
President, Phone: [phone] ext. 238, E-mail: [e-mail]