SemBioSys begins phase I/II trial of insulin produced in plant seeds

    TSX symbol: SBS

    CALGARY, Dec. 3 /CNW/ - SemBioSys Genetics Inc. (TSX:SBS), a
biotechnology company developing protein pharmaceuticals in crop plants, today
announced that it has initiated a phase I/II clinical trial of its
plant-produced insulin with the first injection of its drug in humans. The
trial, taking place in the United Kingdom (UK), will include up to 30 healthy
volunteers in a three-arm study (SBS-1000 insulin and two commercial
standards) to demonstrate the bioequivalence of safflower-produced insulin to
comparator insulin products. Full results are expected to be available during
the first half of 2009.
    "We have commenced the planned phase I/II clinical trial with plant-made
insulin. This is the largest volume biopharmaceutical ever produced in
plants," stated Bruce Given, M.D., acting chief medical officer at SemBioSys.
"This sophisticated trial is designed to show bioequivalence with respect to
insulin concentrations as well as insulin action on blood glucose.
Bioequivalence is being measured by comparing SBS-1000 to commercially
available insulin currently used to treat diabetes."
    "The initiation of the phase I/II clinical trial for plant-produced
insulin is a major milestone for SemBioSys. The trial is the first in which
plant-produced insulin has been injected into humans and supports the exciting
potential for the establishment of plant-produced drugs in the pharmaceutical
sector," said Andrew Baum, president and chief executive officer of SemBioSys.
"This trial verifies the viability of plant made insulin and defines the
regulatory path for plant-made biopharmaceuticals. This trial also represents
significant risk reduction for potential large pharmaceutical partners for our
insulin and Apo AI Milano programs."
    SemBioSys prepared the clinical material in its Current Good
Manufacturing Practice (cGMP) compliant manufacturing plant, which underwent a
successful cGMP inspection as required by European Union (EU) regulations.
Successful completion of this clinical trial in Europe should contribute to
the satisfaction of regulatory requirements in Europe and North America. Both
the United States and European regulatory authorities have confirmed that
SBS-1000 insulin is eligible to receive approval through an abbreviated
regulatory path.

    About SBS-1000

    SBS-1000 is human insulin produced from genetically enhanced safflower.
SemBioSys has demonstrated that SBS-1000 insulin is physically, structurally
and functionally indistinguishable from pharmaceutical-grade human insulin
through analytical testing and pre-clinical sub-chronic toxicology studies in
rodents and primates.

    About SemBioSys Genetics Inc.

    Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company
developing protein-based pharmaceuticals using its proprietary protein
production technology. This technology enables the production of therapeutic
proteins in plant seeds by genetically enhancing the safflower plant. The
Company's lead pharmaceutical candidates are recombinant human insulin, which
intends to serve the rapidly expanding global diabetes market, and Apo AI
Milano. Apo AI Milano is a variant of Apo AI, the major protein associated
with high density lipoprotein (HDL), or "good cholesterol", whose function is
to remove excess cholesterol from arteries. In addition to its pharmaceutical
products, SemBioSys' subsidiary, Botaneco Specialty Ingredients Inc., is
selling oleosome-based all natural products in the global personal care
ingredient market. More information is available and can be accessed 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 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.: Andrew Baum, President
and Chief Executive Officer, Phone: [phone], E-mail:
[e-mail]; The Trout Group: Christine Labaree, Managing Director,
Phone: [phone], E-mail: [e-mail]