SemBioSys updates Apo AI development program

    TSX symbol: SBS

    - Canadian Biotechnology Company confirms commercial expression levels of
    Apo AI Milano variant and clarifies status of native Apo AI -

    CALGARY, Aug. 22 /CNW/ - SemBioSys Genetics Inc. (TSX:SBS), a
biotechnology company developing a portfolio of therapeutic proteins for
metabolic and cardiovascular diseases, today updated a release issued on
July 12, 2007 announcing that the Company had achieved commercial levels of
apolipoprotein AI (native Apo AI) and apolipoprotein AI(Milano) (Apo AI
Milano) accumulation in safflower seed lines. SemBioSys has confirmed in
multiple assays that it has developed commercial levels of Apo AI Milano in
safflower seed lines. Based on further evaluation of the existing data from
native Apo AI safflower seed lines, the Company must clarify that, to date, it
has not proven it has achieved commercial levels of native Apo AI accumulation
in safflower.
    While the assays demonstrate that native Apo AI accumulates in safflower,
the commercial level threshold set by SemBioSys of 1% total seed protein
expression has not yet been attained. Over the coming months SemBioSys will
continue to analyze the additional safflower seed lines it currently has in
development. The Company expects that the analysis of these seed lines will be
complete by the end of the fourth quarter of 2007.
    "While this is a setback to our native Apo AI program, we believe it is
temporary in nature. Our success with the Milano variant has given us
confidence that similar accumulation levels will be found among the remaining
native Apo AI plant lines we have created. We successfully achieved the
commercial threshold for Apo AI Milano early in our current series of seed
lines. We initially believed we had achieved a similar outcome in an early
seed line from the native Apo AI series. We are currently, and will continue,
analyzing new seed lines between now and the end of 2007 as they become
available," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "In
the meantime, we will continue to scale-up the successful Apo AI Milano seed
lines to allow us to initiate animal trials with this material as soon as
    SemBioSys expects to receive in vivo efficacy results from animal trials
for Apo AI produced in its model plant system, Arabidopsis, before the end of
2007. The Company is currently scaling up safflower-produced Apo AI Milano in
order to initiate preclinical animal trials as soon as sufficient material is
    The Company currently intends to partner one, or both, of the native Apo
AI and Apo AI Milano programs prior to or shortly after Phase I clinical
trials in 2009. SemBioSys believes its proprietary oilbody-oleosin production
system offers the potential to overcome the manufacturing cost and capacity
challenges of traditional fermentation-based technologies that have impeded
the commercial development of Apo AI.

    About Apo AI

    Apo AI is a developmental-stage cardiovascular therapy, designed to
rapidly stabilize and diminish atherosclerotic plaque for the prevention and
treatment of cardiovascular disease. Apo AI is the major apolipoprotein
associated with HDL, commonly referred to as "good cholesterol", which
naturally removes plaque from arteries. Apo AI Milano is a natural variant of
native human Apo AI characterized by a single amino acid substitution in its
primary structure. In an epidemiological study, Apo AI Milano appears to
confer enhanced resistance to atherosclerosis, suggesting that it may offer
clinical advantages in the treatment of cardiovascular disease.
    In a six week clinical trial, Esperion Therapeutics (acquired by Pfizer
in 2003) demonstrated that its Apo AI Milano variant/phospholipid formulation
could reduce plaque volume at a level and speed of atherosclerotic regression
unattainable with any current drug therapy. Similarly, both CSL Limited and
Borean Pharma A/S have more recently confirmed the strong therapeutic
potential of their respective Apo AI-based drug candidates (CSL-111 and
Trimeric Apo A-I) in clinical and preclinical trials.
    High dosing (up to 20 grams per course of patient treatment) coupled with
a large patient population is expected to drive volume demand of several
tonnes of Apo AI per year, underscoring the value of a highly scalable plant
manufacturing solution.

    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). Drugs positioned in the
cholesterol and triglyceride management market are the single largest class of
prescription pharmaceuticals, with global sales exceeding US$35 billion 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 lead pharmaceutical candidates, produced in the plant
host safflower, are recombinant human insulin to serve the rapidly expanding
global diabetes market and Apo AI, a next generation cardiovascular drug. In
addition to its pharmaceutical products, SemBioSys is developing a series of
non-pharmaceutical products addressing human topical, nutritional oils and
animal health markets.

    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, the successful and timely completion
of clinical studies, 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., Mr. Andrew Baum,
President and Chief Executive Officer, Phone: (403) 717-8767, Fax: (403)
250-3886, E-mail:, Internet:; Investor
Relations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail:

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