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

    Company Achieves Important Milestone in Development of Next Generation
    Cardiovascular Drug

    CALGARY, June 5 /CNW/ - 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
    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 $34 billion global market in

    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

    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 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:

For further information: SemBioSys Genetics Inc., Andrew Baum, President
and Chief Executive Officer, Phone: (403) 717-8767, E-mail:; The Trout Group, Ian Clements, Senior Vice President,
Phone: (415) 392-3385, E-mail:

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