SemBioSys' plant-derived Apo AI(Milano) demonstrates encouraging biologic activity in seven preclinical models

    CALGARY, May 19 /CNW/ - SemBioSys Genetics Inc. (TSX:SBS), specializing
in the manufacture of high-value proteins and oils in plant seeds, today
reported encouraging data from the Company's Apo AI(Milano) development
program. Results from recent preclinical studies show that SemBioSys'
plant-derived Apo AI(Milano) has exhibited the appropriate biological
activity, including the ability to reduce overall plaque volume.
    New data from two of the largest and most detailed studies, of the seven
completed to date, have just been reported from a collaboration between
SemBioSys and Prediman K. Shah, MD and colleagues at Cedars-Sinai Heart
Institute in Los Angeles, CA. Shah, a cardiologist and cardiovascular
researcher, is a leading authority on apolipoproteins and cardiovascular
health and the first researcher to demonstrate the effects of Apo AI(Milano)
in whole animal models.
    In Dr. Shah's laboratory, two types of whole animal model experiments
were performed using hypercholesterolemic mice (mice with high levels of
atherosclerosis resulting from a high fat diet) in order to determine the
effects of SemBioSys' plant-made Apo AI(Milano). Single injection, short-term
studies on cholesterol mobilization and plaque lipid content were conducted,
as well as, longer-term, multiple injection studies on the extent of
atherosclerotic lesion accumulation. Both experiments confirmed
anti-atherosclerotic effects of plant-derived Apo AI(Milano) in the regulation
of cholesterol mobilization from the arterial wall, in the lipid content of
atherosclerotic plaques, and in the reduction of overall volume of
atherosclerotic plaque after multiple injections. Full results of the studies
will be submitted to an upcoming scientific conference.
    Additional in vitro cellular assays have also demonstrated the desired
ability of SemBioSys' Apo AI(Milano) to remove cholesterol from various cell
types. In all, seven different types of experiments have been performed at
four outside laboratories and each one has shown the molecule to be
biologically active.
    Dr. Shah noted, "These results are promising and demonstrate that
plant-derived Apo AI(Milano) functions in a manner consistent with its known
effects in test animals. The use of plants as an inexpensive, abundant source
of Apo AI(Milano) opens up many possibilities for the therapeutic use of Apo
AI(Milano) and we are very enthusiastic to continue our research with this new
source of the molecule."
    Dr Maurice Moloney, Chief Scientific Officer at SemBioSys, commented,
"Dr. Shah's work, along with studies conducted by additional academic and
commercial parties, has helped demonstrate the viability of our plant-made Apo
AI(Milano) as a therapeutic candidate. Given the very high prevalence and
human toll of atherosclerosis, such as heart attack and stroke, we are very
encouraged by this progress."

    About SemBioSys' Apo AI(Milano)

    Apo AI (also known as apolipoprotein 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 SemBioSys

    Calgary, Alberta-based SemBioSys is a world leader in manufacturing
high-value proteins and oils in plant seeds. With its unique proprietary
platform, SemBioSys provides partners with product enablement, exceptionally
low cost and unprecedented scalability. The Company applies this platform with
high selectivity to opportunities where it has a unique competitive advantage.
Since its inception, SemBioSys has produced more than 50 non-native proteins
and oils using its patented seed technology, demonstrating applicability
across a broad range of industries such as pharmaceuticals, personal care and
industrial products. The Company's current pharmaceutical development programs
include insulin (SBS-1000, regulated as a biosimilar in Europe) and Apo
AI(Milano), a next-generation cardiovascular therapy. SemBioSys is listed on
the Toronto Stock Exchange under the ticker SBS. More information is available

    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 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, the submission of a CTA to the appropriate European
authorities, the successful initiation and timely and successful completion of
clinical studies, the fact that Apo AI(Milano) 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.: Abby Garfunkel,
Investor Relations, Phone: (403) 717-4185, E-mail:;
The Trout Group: Christine Labaree, Managing Director, Phone: (617) 583-1307,
E-mail:; The Equicom Group Inc.: Ross Marshall, Vice
President, Phone: (416) 815-0700 ext. 238, E-mail:

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