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SemBioSys begins phase I/II trial of insulin produced in plant seeds
Posted by: Prof. Dr. M. Raupp (IP Logged)
Date: December 06, 2008 07:44PM

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.
www.checkbiotech.org



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