SemBioSys Eligible to Proceed With Phase I/II Plant-Produced Insulin Trial After Submission of IND

Calgary, Canada (ots/PRNewswire) -

- TSX symbol: SBS

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 US$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 http://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 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.

For further information: SemBioSys Genetics Inc.: Andrew Baum,
President and Chief Executive Officer, Phone: +1-403-717-8767,
E-mail: bauma@sembiosys.com; The Trout Group: Ian Clements, Senior
Vice President, Phone: +1-415-392-3385, E-mail:
iclements@troutgroup.com

ots Originaltext: SemBioSys, Genetics Inc
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information: SemBioSys Genetics Inc.: Andrew Baum,
President and Chief Executive Officer, Phone: +1-403-717-8767,
E-mail: bauma@sembiosys.com; The Trout Group: Ian Clements, Senior
Vice President, Phone: +1-415-392-3385, E-mail:
iclements@troutgroup.com