Calgary, Alberta, Canada
December 3, 2008
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. |
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