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SemBioSys, Genetics Inc

SemBioSys Demonstrates Functionality of its Safflower Produced Apo AI(Milano)

Calgary, Canada (ots/PRNewswire)

- Company Achieves Important Milestone in Development of Next
Generation Cardiovascular Drug
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company
dedicated to developing a portfolio of therapeutic proteins for
metabolic and cardiovascular diseases, today announced that it has
demonstrated that its safflower-produced Apo AI(Milano) (safflower
Apo AI(Milano)) is functional in a widely accepted animal model.
Working with the laboratory of Dr. Jean Claude Tardif at the Montreal
Heart Institute (MHI), the company demonstrated that safflower Apo
AI(Milano) increased cholesterol mobilization substantially in mice
which, in conjunction with analytical and in vitro assays, indicates
that safflower Apo AI(Milano) is physiologically and pharmaceutically
comparable to microbially-produced Apo AI. In human trials,
microbially-produced Apo AI(Milano) has been demonstrated to remove
plaque from arteries (plaque regression), and holds potential for
addressing one of the greatest unmet medical needs today - the
reversal of atherosclerosis.
Dr. Maurice Moloney, founder and chief scientific officer of
SemBioSys commented, "Scientists at SemBioSys and our academic
collaborators have conducted extensive work on safflower Apo
AI(Milano) and have established that safflower Apo AI(Milano) is
comparable to Apo AI derived from other sources, as described in the
literature. Its identity and functionality was confirmed through use
of mass spectrometry, and lipid clearance, cellular cholesterol
efflux and whole-animal cholesterol mobilization assays."
Dr. Jean-Claude Tardif, director of the Montreal Heart Institute
Research Centre, who is a world leader in the study of HDLs and the
physiological role of Apo AI noted, "Apo AI and Apo AI(Milano) hold
the potential to be a useful therapy for the treatment of
cardiovascular disease through the unique mechanism of plaque
regression. Our research at the MHI fully supports the idea that
HDL-based therapies are potentially the next frontier in the battle
against cardiovascular disease."
"Apo AI(Milano) is a drug candidate with outstanding clinical and
commercial potential," said Andrew Baum, president and chief
executive officer of SemBioSys. "Manufacturing challenges have been a
major impediment to drug development efforts. We have now shown that
safflower Apo AI(Milano), which we believe can be produced in a cost
effective manner, has the potential to allow for the full development
and commercialization of this drug candidate. We expect that the data
we have previously generated, together with the latest animal model
data, will greatly facilitate and accelerate our partnership efforts
for this program."
About Apo AI/Apo AI(Milano)
Apo AI is a naturally occurring human protein being developed as
a cardiovascular therapy to stabilize and reverse atherosclerotic
plaque deposition for the prevention and treatment of cardiovascular
disease. Apo AI is believed by many clinicians to be the archetype
for a new generation of cardiovascular drugs (HDL therapies). Apo AI
is the major apolipoprotein associated with HDL, commonly referred to
as "good cholesterol", which naturally removes plaque from arteries.
Published studies have shown that Apo AI(Milano), which is a variant
of Apo AI, in a phospholipid formulation could reduce plaque volume
at a level and speed unattainable with any current drug therapy. If
successfully commercialized, predicted high dosing (multiple grams
per course of patient treatment) coupled with a large patient
population would be expected to drive volume demand of several tons
of Apo AI(Milano) per year, underscoring the value of a highly
scalable, plant manufacturing solution. SemBioSys' proprietary
safflower derived Apo AI(Milano) is a des I, 2 variant of Apo
AI(Milano) as previously described in the literature.
About Cardiovascular Disease
Atherosclerotic cardiovascular diseases are the leading cause of
mortality in developed nations and by 2010 are projected to become
the leading cause of mortality worldwide. In the United States,
coronary heart disease and stroke account for 70% of
cardiovascular-related deaths, which claims more lives each year than
the next four leading causes of death combined (cancer, respiratory
disease, accidents and diabetes). Cardiovascular drugs targeting
cholesterol and lipid regulation represented a CAD$34 billion global
market in 2007.
About SemBioSys Genetics Inc.
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology
company developing protein-based pharmaceuticals for metabolic and
cardiovascular diseases. The Company's technology platform allows for
the production of pharmaceutical proteins in an easily scalable, very
low cost (in terms of both capital and COGS) manner. The Company's
lead pharmaceutical candidates, produced in the plant host safflower,
are recombinant human insulin to serve the rapidly expanding global
diabetes market and Apo AI(Milano), a next generation cardiovascular
drug. SemBioSys also owns Botaneco Specialty Ingredients Inc., a
supplier of specialty ingredients to the personal care and topical
OTC and Rx markets. More information on the company can be found at
http://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 Canadian 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 and
the successful and timely 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
http://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: +1-403-717-8767,
E-mail:  bauma@sembiosys.com; The Trout Group, Ian Clements, Senior
Vice President, Phone: +1-415-392-3385, E-mail: 
iclements@troutgroup.com

Contact:

For further information: SemBioSys Genetics Inc., Andrew Baum,
President and Chief Executive Officer, Phone: +1-403-717-8767,
E-mail: bauma@sembiosys.com; The Trout Group, Ian Clements, Senior
Vice President, Phone: +1-415-392-3385, E-mail:
iclements@troutgroup.com

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