SemBioSys Genetics Inc. Completes Pre-IND Meeting With U.S. FDA For APO AI(milano)
CALGARY, Aug. 11– SemBioSys Genetics Inc. (TSX:SBS) announced that it has received the minutes of a successful and productive pre-investigational new drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding Apo AIMilano, a next-generation cardiovascular drug. The meeting focused on the development plans for Apo AIMilano, during which the FDA confirmed SemBioSys’ development strategy necessary to file an IND application and addressed the proposed design of clinical trials for Apo AIMilano.
“We are encouraged by the feedback we have received from the FDA, particularly in regard to our development plan required to advance Apo AIMilano to clinical trials. This will be the second pharmaceutical candidate to be studied in human clinical trials produced using SemBioSys’ plant-based production system,” said James Szarko, Chief Executive Officer of SemBioSys. “Because of its unique ability to promote plaque regression, Apo AIMilano has the potential to revolutionize clinical practice and significantly improve outcomes in patients with cardiovascular disease.”
In collaboration with leading cardiologists and cardiovascular researchers, SemBioSys has confirmed the activity of plant-derived Apo AIMilano in seven preclinical models. The Company has demonstrated the anti-atherosclerotic effects of Apo AIMilano based on cholesterol mobilization from the arterial wall, lipid content of atherosclerotic plaques, and the reduction of overall volume of atherosclerotic plaque after multiple injections.
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 AIMilano, a next-generation cardiovascular therapy. SemBioSys' proprietary safflower-derived Apo AIMilano is a des-1,2- variant of Apo AIMilano as previously described in the literature. 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.
“We are encouraged by the feedback we have received from the FDA, particularly in regard to our development plan required to advance Apo AIMilano to clinical trials. This will be the second pharmaceutical candidate to be studied in human clinical trials produced using SemBioSys’ plant-based production system,” said James Szarko, Chief Executive Officer of SemBioSys. “Because of its unique ability to promote plaque regression, Apo AIMilano has the potential to revolutionize clinical practice and significantly improve outcomes in patients with cardiovascular disease.”
In collaboration with leading cardiologists and cardiovascular researchers, SemBioSys has confirmed the activity of plant-derived Apo AIMilano in seven preclinical models. The Company has demonstrated the anti-atherosclerotic effects of Apo AIMilano based on cholesterol mobilization from the arterial wall, lipid content of atherosclerotic plaques, and the reduction of overall volume of atherosclerotic plaque after multiple injections.
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 AIMilano, a next-generation cardiovascular therapy. SemBioSys' proprietary safflower-derived Apo AIMilano is a des-1,2- variant of Apo AIMilano as previously described in the literature. 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.