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SemBioSys, Genetics Inc

SemBioSys Initiates Toxicology Study for Safflower-Produced Insulin

Calgary, Canada (ots/PRNewswire)

- Initiation of Study Puts Company on Track for Phase I/II Trial
SemBioSys Genetics Inc. (TSX: SBS), a biotechnology company
developing a portfolio of therapeutic proteins for metabolic and
cardiovascular diseases, today announced that it has initiated a
toxicology study in animals to demonstrate the safety and
comparability of its safflower-produced insulin to pharmaceutical
grade human insulin. This study is a final key step in the Company's
preparations to submit an Investigational New Drug (IND) application
to the U.S. Food and Drug Administration (FDA) in the third quarter
in order to initiate a Phase I/II human clinical trial this year. The
28-day repeat dose study in monkeys and rats is the only toxicology
study required before submission of the IND application to the FDA.
The study is also a required component for the abbreviated 505(b)(2)
application process that SemBioSys is eligible to follow, based on
the well-characterized nature of insulin. The study aims to establish
that the toxicology profile of insulin produced from SemBioSys' plant
system is appropriate to begin human trials.
"Insulin is currently one of the largest volume recombinant
biopharmaceutical products on the market and demand is projected to
increase dramatically in the coming years. The scalability of our
safflower-produced insulin has the potential to provide a
cost-effective source of insulin to meet this growing demand," said
Andrew Baum, President and CEO of SemBioSys. "In order to start the
toxicology study we had to demonstrate that our safflower-produced
insulin is chemically, physically and structurally equivalent to
human insulin using a broad array of assays. The toxicology study is
an important milestone for our insulin program and demonstrates that
we are on track to begin human clinical trials in the second half of
2008."
SemBioSys has already established that safflower-produced insulin
is physically, structurally and physiologically indistinguishable
from pharmaceutical-grade human recombinant insulin in laboratory
testing. In a standard quantitative blood sugar assay performed in
rabbits (insulin tolerance test), SemBioSys has demonstrated the
pharmacodynamic equivalence of safflower-produced insulin to
pharmaceutical-grade insulin. Thus the completion of this toxicology
study fulfills the pre-requisite for filing the IND.
The world market for insulin is 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. 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 will offer dramatic capital and
operating cost reductions with the potential to enter the market as a
low-cost source of insulin to meet this exploding demand.
About SemBioSys Genetics Inc. (http://www.sembiosys.com)
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 AI, a next generation cardiovascular drug. In addition to its
pharmaceutical products, SemBioSys is developing a series of
non-pharmaceutical products addressing human topical, nutritional
oils and agricultural biotechnology markets.
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 Canadian 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, the successful and
timely completion of clinical studies, 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 http://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.
For further information:
    SemBioSys Genetics Inc.,
    Mr. Andrew Baum, President and Chief Executive Officer,
    Phone: +1(403)-717-8767,
    Fax: +1(403)-250-3886,
    E-mail:  bauma@sembiosys.com,
    Internet: http://www.sembiosys.com;
    Investor Relations,
    Ross Marshall, The Equicom Group Inc.,
    Phone: +1(416)-815-0700 (Ext. 238),
    Fax: +1(416)-815-0080,
    E-mail:  rmarshall@equicomgroup.com

Contact:

For further information: SemBioSys Genetics Inc., Mr. Andrew Baum,
President and Chief Executive Officer, Phone: +1(403)-717-8767, Fax:
+1(403)-250-3886, E-mail: bauma@sembiosys.com; Investor Relations,
Ross Marshall, The Equicom Group Inc., Phone: +1(416)-815-0700 (Ext.
238), Fax: +1(416)-815-0080, E-mail: rmarshall@equicomgroup.com

Plus de actualités: SemBioSys, Genetics Inc
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