Calgary, Alberta
October 18, 2007
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company
developing a portfolio of therapeutic proteins for
metabolic and cardiovascular diseases, today announced that it
has achieved the commercial threshold of apolipoprotein AI
(native Apo AI) accumulation in safflower seed. While SemBioSys
confirmed in a press release dated August 22, 2007 that it had
achieved commercially viable levels of the Apo AI(Milano)
variant, it has now also attained commercial levels of native
Apo AI in safflower.
"These results confirm that we have successfully achieved our
commercial threshold for native Apo AI accumulation in
safflower, in addition to achieving the Apo AI(Milano) variant
threshold, which together represent a key milestone in our
cardiovascular drug development program and which open further
opportunities for partnerships. We believe that plant-produced
Apo AI will overcome the cost and capacity challenges of
manufacturing Apo AI with traditional fermentation-based
production systems, making it an attractive candidate for any
pharmaceutical company with a presence, or desire to create a
presence, in the cardiovascular market," said Andrew Baum,
President and CEO of SemBioSys Genetics Inc. "We intend to
perform the necessary preclinical work during the remainder of
2007 and 2008, and anticipate initiating clinical trials in 2009
of safflower-produced Apo AI. In the meantime, during the fourth
quarter of 2007 we intend to perform the necessary work to
confirm that Apo AI produced in our model plant system,
Arabidopsis, is functionally equivalent to natural Apo AI in
mammals."
The Company currently intends to partner one, or both, of the
native Apo AI and Apo AI(Milano) variant 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-based therapies.
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
believed by many clinicians to be the basis for the next
generation of cardiovascular drugs, which represented a $35
billion market in 2006. Apo AI is the major apolipoprotein
associated with HDL, commonly referred to as "good cholesterol",
which naturally removes plaque from arteries.
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.
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. |
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