SemBioSys completes pre-IND meeting with U.S. FDA for Apo AI(Milano)

    TSX symbol: SBS

    CALGARY, Aug. 11 /CNW/ - 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 AI(Milano), a next-generation cardiovascular drug. The meeting
focused on the development plans for Apo AI(Milano), during which the FDA
confirmed SemBioSys' development strategy necessary to file an IND application
and addressed the proposed design of clinical trials for Apo AI(Milano).
    "We are encouraged by the feedback we have received from the FDA,
particularly in regard to our development plan required to advance Apo
AI(Milano) 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
AI(Milano) 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
AI(Milano) in seven preclinical models. The Company has demonstrated the
anti-atherosclerotic effects of Apo AI(Milano) based on cholesterol
mobilization from the arterial wall, lipid content of atherosclerotic plaques,
and the reduction of overall volume of atherosclerotic plaque after multiple

    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' proprietary
safflower-derived Apo AI(Milano) is a des-1,2- variant of Apo AI(Milano) as
previously described in the literature. SemBioSys is listed on the Toronto
Stock Exchange under the ticker SBS. More information is available at

    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 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.

For further information:

For further information: SemBioSys Genetics Inc., Abby Garfunkel,
Investor Relations, Phone: (403) 717-4185, E-mail:;
The Trout Group, Christine Labaree, Managing Director, Phone: (617) 583-1307,
E-mail:; The Equicom Group Inc., Ross Marshall, Vice
President, Phone: (416) 815-0700 ext. 238, E-mail:

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