CALGARY, May 19 - SemBioSys Genetics Inc. (TSX:SBS), specializing in the manufacture of high-value proteins and oils in plant seeds, today reported encouraging data from the Company’s Apo AI(Milano) development program. Results from recent preclinical studies show that SemBioSys’ plant-derived Apo AI(Milano) has exhibited the appropriate biological activity, including the ability to reduce overall plaque volume.
New data from two of the largest and most detailed studies, of the seven completed to date, have just been reported from a collaboration between SemBioSys and Prediman K. Shah, MD and colleagues at Cedars-Sinai Heart Institute in Los Angeles, CA. Shah, a cardiologist and cardiovascular researcher, is a leading authority on apolipoproteins and cardiovascular health and the first researcher to demonstrate the effects of Apo AI(Milano) in whole animal models.
In Dr. Shah’s laboratory, two types of whole animal model experiments were performed using hypercholesterolemic mice (mice with high levels of atherosclerosis resulting from a high fat diet) in order to determine the effects of SemBioSys’ plant-made Apo AI(Milano). Single injection, short-term studies on cholesterol mobilization and plaque lipid content were conducted, as well as, longer-term, multiple injection studies on the extent of atherosclerotic lesion accumulation. Both experiments confirmed anti-atherosclerotic effects of plant-derived Apo AI(Milano) in the regulation of cholesterol mobilization from the arterial wall, in the lipid content of atherosclerotic plaques, and in the reduction of overall volume of atherosclerotic plaque after multiple injections. Full results of the studies will be submitted to an upcoming scientific conference.
Additional in vitro cellular assays have also demonstrated the desired ability of SemBioSys’ Apo AI(Milano) to remove cholesterol from various cell types. In all, seven different types of experiments have been performed at four outside laboratories and each one has shown the molecule to be biologically active.
Dr. Shah noted, “These results are promising and demonstrate that plant-derived Apo AI(Milano) functions in a manner consistent with its known effects in test animals. The use of plants as an inexpensive, abundant source of Apo AI(Milano) opens up many possibilities for the therapeutic use of Apo AI(Milano) and we are very enthusiastic to continue our research with this new source of the molecule.”
Dr Maurice Moloney, Chief Scientific Officer at SemBioSys, commented, “Dr. Shah’s work, along with studies conducted by additional academic and commercial parties, has helped demonstrate the viability of our plant-made Apo AI(Milano) as a therapeutic candidate. Given the very high prevalence and human toll of atherosclerosis, such as heart attack and stroke, we are very encouraged by this progress.”
About SemBioSys’ Apo AI(Milano)
Apo AI (also known as apolipoprotein 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 SemBioSys
Calgary, Alberta-based SemBioSys is a world leader in manufacturing high-value proteins and oils in plant seeds. With its unique proprietary platform, SemBioSys provides partners with product enablement, exceptionally low cost and unprecedented scalability. The Company applies this platform with high selectivity to opportunities where it has a unique competitive advantage. Since its inception, SemBioSys has produced more than 50 non-native proteins and oils using its patented seed technology, demonstrating applicability across a broad range of industries such as pharmaceuticals, personal care and industrial products. The Company’s current pharmaceutical development programs include insulin (SBS-1000, regulated as a biosimilar in Europe) and Apo AI(Milano), a next-generation cardiovascular therapy. SemBioSys is listed on the Toronto Stock Exchange under the ticker SBS. More information is available 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 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, the submission of a CTA to the appropriate European authorities, the successful initiation and timely and successful completion of clinical studies, the fact that Apo AI(Milano) 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.
