Calgary, Alberta
July 29, 2008
Submission demonstrates
progress of plant-derived insulin program scheduled to enter the
clinic later this year
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
simultaneously."
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.
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 www.sembiosys.com.
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