SemBioSys eligible to proceed with Phase I/II plant-produced insulin trial after submission of IND

    TSX symbol: SBS

    CALGARY, Sept. 16 /CNW/ - SemBioSys Genetics Inc. (TSX:SBS), a
biotechnology company developing a portfolio of therapeutic proteins for
metabolic and cardiovascular diseases, today announced that it is eligible to
proceed with its planned Phase I/II human clinical trial of plant-produced
insulin now that the 30-day review period of its Investigational New Drug
(IND) application has passed. SemBioSys submitted the application in July to
the U.S. Food and Drug Administration (FDA), which has now completed its
review of the file. As previously announced, SemBioSys intends to conduct the
Phase I/II insulin trial in Europe. Prior to proceeding with the planned trial
in the United Kingdom, the company's Clinical Trial Application (CTA) must be
reviewed by the appropriate European regulatory authorities.
    "The company continues to achieve its insulin development milestones on
time. Our recent accomplishments confirm our confidence in our regulatory and
development strategy using plants as a low-cost production host for insulin.
Plant-produced human recombinant insulin represents a major step forward in
insulin production. We believe, furthermore, that these upcoming studies could
prove to be the greatest achievement in insulin production since the advent of
recombinant human insulin in the early 80's," said Andrew Baum, president and
chief executive officer of SemBioSys. "The purpose of filing an IND in the
U.S., even though we intend to conduct the trial in Europe, is to ensure that
we can pursue U.S. and European regulatory approval of our plant-produced
insulin contemporaneously. Conducting the planned insulin trial in Europe
allows us to establish the bioequivalence of our safflower-produced insulin to
commercially available insulin products from both the U.S. and Europe in a
single trial."
    SemBioSys plans to initiate a Phase I/II human trial of its
safflower-produced insulin in the United Kingdom during the fourth quarter of
2008. Prior to proceeding with the trial the company must await clearance from
the Medicines and Healthcare products Regulatory Agency (MHRA) in the United
Kingdom. SemBioSys' planned Phase I/II human clinical trial is designed to
enroll up to 30 healthy volunteers in a three-arm study to demonstrate the
bioequivalence of safflower-produced insulin to comparator insulin products.
The European authorities are the first major healthcare regulators to have
published guidance documents that ensure insulin is eligible to receive
approval through an abbreviated regulatory path. Separately, the U.S. FDA has
advised SemBioSys that safflower-produced insulin is eligible to receive
approval through an abbreviated 505(b)(2) approval process.
    The world market value for insulin is estimated to be in excess of
US$7.1 billion today and the demand for insulin is projected to increase due
to two factors. The growing incidence of diabetes combined with the expanded
use of insulin therapy is expected to almost double insulin demand over the
next five years and increase the global insulin market to over $15 billion by
2012. SemBioSys' plant-made insulin is expected to offer substantial capital
and cost-of-goods reductions with the potential to enter the market as a
low-cost, easily expandable source of insulin to meet exploding global demand.

    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 lead pharmaceutical candidates, produced in the plant
host safflower, are recombinant human insulin to serve the rapidly expanding
global diabetes market and Apo AIMilano, a next generation cardiovascular
drug. In addition to its pharmaceutical products, SemBioSys and its
subsidiary, Botaneco Specialty Ingredients Inc., are developing a series of
non-pharmaceutical products addressing human topical, nutritional oils and
agricultural biotechnology markets. More information is available and can be
accessed 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 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

For further information:

For further information: SemBioSys Genetics Inc.: Andrew Baum, President
and Chief Executive Officer, Phone: (403) 717-8767, E-mail:; The Trout Group: Ian Clements, Senior Vice President,
Phone: (415) 392-3385, E-mail:

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