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SemBioSys Updates Apo AI Development Program

Geschrieben am 22.08.2007 - [Nächster Artikel]

Calgary, Canada (ots/PRNewswire) -

- Canadian Biotechnology Company Confirms Commercial Expression
Levels of Apo AI Milano Variant and Clarifies Status of Native Apo AI

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 seedlines to allow us to initiate animal trials with this
material as soon as possible."

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 available.

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 2006.

About SemBioSys Genetics Inc. (http://www .sembiosys.com)

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 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
noobligation 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.

ots Originaltext: SemBioSys, Genetics Inc
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information: SemBioSys Genetics Inc., Mr. Andrew Baum,
Presidentand Chief Executive Officer, Phone: +1-403-717-8767, Fax:
+1-403-250-3886, E-mail: bauma@sembiosys.com; Investor Relations,
Ross Marshall, The Equicom Group Inc., Phone: +1-416-815-0700
(Ext.238), Fax: +1-416-815-0080, E-mail: rmarshall@equicomgroup.com/
(SBS.)
 
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