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SemBioSys Updates Apo AI Development Program
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.
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For further information: SemBioSys Genetics Inc., Mr. Andrew Baum,
Presidentand Chief Executive Officer, Phone: +1-403-717-8767, Fax:
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