SemBioSys submits IND for safflower-produced insulin to U.S. FDA

    - Submission demonstrates progress of plant-derived insulin program
    scheduled to enter the clinic later this year -

    TSX symbol: SBS

    CALGARY, July 29 /CNW/ - SemBioSys Genetics Inc. (TSX:SBS), a
biotechnology company developing a portfolio of therapeutic proteins for
metabolic and cardiovascular diseases, today announced that it has submitted
an Investigational New Drug (IND) application for safflower-produced
recombinant human insulin to the United States Food and Drug Administration
(FDA). The IND application contains a physical, chemical and structural
analysis of safflower-produced insulin to a reference standard, results from
28-day sub-chronic toxicology studies in two species of mammals, demonstration
of pharmacodynamic function in animals and describes a cGMP process for the
production of safflower-produced insulin. SemBioSys plans to initiate a
Phase I/II clinical study of its safflower-produced insulin in the
fourth quarter of 2008.
    "The submission of the IND is a critical step toward the initiation of a
Phase I/II clinical trial with our recombinant human insulin produced from
safflower. All of our studies to date confirm that our safflower-produced
insulin is equivalent to pharmaceutical-grade human insulin. We met our
internal schedule to submit the IND and we are on track to begin human
clinical trials in the fourth quarter of 2008 as planned," said Andrew Baum,
president and chief executive officer of SemBioSys. "While we intend to
initiate our first clinical trial for insulin in the UK, a successful
IND application will provide us with the opportunity to consult the FDA on
later stage clinical development. We believe this will allow us to apply for
European and U.S. approvals for our safflower-produced insulin
    SemBioSys also intends to submit a Clinical Trial Application (CTA) to
the appropriate European authorities later this quarter. Assuming approval of
the CTA, SemBioSys intends to conduct a Phase I/II trial in the UK. The CTA
requests approval to initiate a Phase I/II human clinical trial designed to
enroll up to 30 healthy volunteers to demonstrate the bioequivalence of
safflower-produced insulin to comparator insulin products. After discussions
with the FDA in late 2006, SemBioSys was informed that safflower-produced
insulin is eligible to receive approval through an abbreviated 505(b)(2)
regulatory path. The European authorities have already published guidance
documents concerning the approval of human insulin which are consistent with
this approach.
    The world market 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: demographic and dietary choices in the western world are
causing an increase in the incidence of diabetes; and at the same time,
countries in the rest of the world that are currently underserved in the
insulin market, are demanding greater access to insulin at an affordable
price. By 2012, independent estimates predict a US$15 billion insulin market.
SemBioSys' plant-made insulin is expected to offer capital and operating cost
reductions with the potential to enter the market as a low-cost, easily
expandable source of insulin to meet this exploding 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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