CALGARY, June 5 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), specializing in the manufacture of high-value proteins and oils in plant seeds, today announced that it will present the recent results of the Phase I/II study with its biosimilar human insulin in a late-breaking scientific poster at the American Diabetes Association's (ADA) 69th Scientific Sessions in New Orleans. The poster presentation will take place at the Morial Convention Center Poster Hall E on Sunday, June 7th and is entitled: "Analytical Characterization, Safety and Clinical Bioequivalence of Recombinant Human Insulin from Transgenic Plants," by Joseph Boothe and colleagues. The abstract for the presentation is available via the ADA website at http://ww2.aievolution.com/ada0901/index.cfm?do=abs.viewAbs&abs=7845.
The poster presentation details the clinical trial results of SemBioSys' first "in-man" clinical study of SBS-1000, a recombinant human insulin manufactured using the Company's proprietary platform, which allows for highly scalable, low cost production. The trial demonstrated that SBS-1000 was bioequivalent to Eli Lilly's Humulin(R) R, a widely-used human insulin in North America, with the expected safety profile. Additionally, SBS-1000 in humans showed pharmacokinetics and pharmacodynamics indistinguishable from Humulin(R) R and was well tolerated at pharmacologically active dosages. SemBioSys plans to publish the complete clinical trial results in a scientific journal in the near future.
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 AIMilano, 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 AIMilano 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.
|SOURCE SemBioSys Genetics Inc.|
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