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SemBioSys Confirms Commercially Viable Levels of Native APO AI in Safflower
Calgary, Canada (ots/PRNewswire) -
- Canadian Biotechnology Company has now Established Commercial Levels of Both Native Apo AI and Apo AI(Milano) variant in Safflower Seed Lines
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. WhileSemBioSys 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 an 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.
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 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 www.sedar.com. 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
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