CALGARY, June 5 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , a biotechnology company dedicated to developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it has demonstrated that its safflower-produced Apo AI(Milano) (safflower Apo AI(Milano)) is functional in a widely accepted animal model. Working with the laboratory of Dr. Jean Claude Tardif at the Montreal Heart Institute (MHI), the company demonstrated that safflower Apo AI(Milano) increased cholesterol mobilization substantially in mice which, in conjunction with analytical and in vitro assays, indicates that safflower Apo AI(Milano) is physiologically and pharmaceutically comparable to microbially-produced Apo AI. In human trials, microbially-produced Apo AI(Milano) has been demonstrated to remove plaque from arteries (plaque regression), and holds potential for addressing one of the greatest unmet medical needs today - the reversal of atherosclerosis.
Dr. Maurice Moloney, founder and chief scientific officer of SemBioSys commented, “Scientists at SemBioSys and our academic collaborators have conducted extensive work on safflower Apo AI(Milano) and have established that safflower Apo AI(Milano) is comparable to Apo AI derived from other sources, as described in the literature. Its identity and functionality was confirmed through use of mass spectrometry, and lipid clearance, cellular cholesterol efflux and whole-animal cholesterol mobilization assays.”
Dr. Jean-Claude Tardif, director of the Montreal Heart Institute Research Centre, who is a world leader in the study of HDLs and the physiological role of Apo AI noted, “Apo AI and Apo AI(Milano) hold the potential to be a useful therapy for the treatment of cardiovascular disease through the unique mechanism of plaque regression. Our research at the MHI fully supports the idea that HDL-based therapies are potentially the next frontier in the battle against cardiovascular disease”.
“Apo AI(Milano) is a drug candidate with outstanding clinical and commercial potential,” said Andrew Baum, president and chief executive officer of SemBioSys. “Manufacturing challenges have been a major impediment to drug development efforts. We have now shown that safflower Apo AI(Milano), which we believe can be produced in a cost effective manner, has the potential to allow for the full development and commercialization of this drug candidate. We expect that the data we have previously generated, together with the latest animal model data, will greatly facilitate and accelerate our partnership efforts for this program.”
About Apo AI/Apo AI(Milano)
Apo 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 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). Cardiovascular drugs targeting cholesterol and lipid regulation represented a $34 billion global market in 2007.
About SemBioSys Genetics Inc.
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company’s technology platform allows for the production of pharmaceutical proteins in an easily scalable, very low cost (in terms of both capital and COGS) manner. 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(Milano), a next generation cardiovascular drug. SemBioSys also owns Botaneco Specialty Ingredients Inc., a supplier of specialty ingredients to the personal care and topical OTC and Rx markets. More information on the company can be found at www.sembiosys.com.
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.
CONTACT: SemBioSys Genetics Inc., Andrew Baum, President and Chief
Executive Officer, Phone: (403) 717-8767, E-mail: bauma@sembiosys.com; The
Trout Group, Ian Clements, Senior Vice President, Phone: (415) 392-3385,
E-mail: iclements@troutgroup.com
