Sirtex Cover.proof 11 - School of Educators

5Section
16
Overview of Sirtex Medical
(ASCO) on 16 May, 1999 and caused great
interest. Sirtex Medical’s presentation at
ASCO was one of a small group of new
studies that was selected out of more than
2000 presentations by the ASCO Committee
for a news conference on ‘New Technologies
for the Future’.
Photograph of a cancer containing SIR-Spheres®. The SIR-
Spheres® have been injected into the blood stream and have
lodged in the small blood vessels of the cancer inside the liver.
Percentage
100
80
60
40
20
0 20 40 60 80
Day post treatment
Alpha-fetoprotein levels in the blood are routinely used as a
guide to the success of treatment in patients with primary
liver cancer. This graph shows the change in alpha-fetoprotein
levels in a group of 46 consecutive patients with primary liver
cancer who were treated with SIR-Spheres® by the Prince of
Wales Hospital in Hong Kong. A fall in the blood alphafetoprotein
level in patients with primary liver cancer is widely
used to determine whether patients have responded favourably
to treatment.
In Hong Kong most patients have been
treated outside of trials as SIR-Spheres ® are
now considered a standard treatment for
primary liver cancer. As well as being highly
effective, treatment with SIR-Spheres ® also
has been reported to have considerably
fewer side effects than alternate treatments
and therefore may well be the preferred
treatment option for many patients.
An important observation from both
Asian and Australian trials is that some
patients with very advanced liver cancer can
be down-staged to the point where their
tumours can be surgically removed and even
cured after treatment with SIR-Spheres ® . In
New Zealand patients are now also treated
with SIR-Spheres ® outside of trials as the
treatment is considered standard therapy
there also.
Manufacturing
SIR-Spheres ® are manufactured under an
agreement with Australian Radioisotopes
(‘ARI’) which is the commercial arm of the
Australian Nuclear Science & Technology
Organisation (‘ANSTO’). ANSTO is an
Australian Government agency that operates
Australia’s only nuclear reactor. ARI is the
major supplier of radiopharmaceutical
agents in Australia and is approved by
the TGA for the manufacture of
radiopharmaceuticals. ARI is actively
expanding its presence in Asia where it
currently markets a range of products.
Regulatory Approval
The marketing of medical products requires
regulatory approval in each country. Sirtex
Medical has obtained regulatory approval for
marketing SIR-Spheres ® in Australia, New
Zealand, Hong Kong and Singapore. Sirtex
Medical’s application to the FDA in the USA
was submitted in October 1999 and is
currently being evaluated. The Company
proposes to submit an application for
marketing approval in the European Union
in the near future.