July 2007
LCT awarded world-first IANZ accreditation for xenotransplantation laboratory
Living Cell Technologies Ltd, funded in part by CWDF with a $50,000 investment, today announced it has been awarded
the world's first xenotransplantation lab accreditation from the International
Accreditation New Zealand (IANZ) body, in a major step towards commencing
clinical trials of DiabeCell in New Zealand this year.
LCT is the first Company world-wide to receive IANZ accreditation for a
xenotransplantation laboratory and this accreditation will ensure that LCT's
laboratory test reports are accepted in forty-nine countries, including the US,
Canada, United Kingdom, Australia and New Zealand.
This formal certification milestone along with recent regulatory approval
for its clinical trial program, moves LCT towards starting a NZ human clinical trial later this calendar year - with regional ethics approval the final
requirement.
LCT's accredited laboratory will use specific diagnostic and monitoring
tests to eliminate the risk of animal viruses passing to humans when
transplanting animal cell products such as DiabeCell into human patients. The accredited
laboratory will have the capability of testing for potential infections in
recipients and to test for a range of appropriate viruses. This is a unique
capability that has been developed by the Company over many years and is fully
owned by LCT.
Although there has not been a single case of pig to human viral infection
after hundreds of treatments and decades of use, the IANZ accreditation is a
requirement before regulatory approval is provided for human clinical trial.
"As far as we know, there is no other single lab in the world that can do
the testing for the full panel of viruses relevant to xeno based cell
products," said Dr Paul Tan, LCT's CEO. "The IANZ accreditation ensures LCT now
possesses the first laboratory that can test for all these viruses in one
internationally approved location."
The IANZ accreditation was granted after detailed and stringent audit of the
competence of the Company and its staff against defined technical and
management system criteria. The assessment was conducted by IANZ staff in
conjunction with experts in molecular diagnostics.
"The IANZ accreditation ensures LCT is conducting its diagnosis and
monitoring of patients in line with international standards and is a necessary
requirement to begin clinical trials with pig cells. It is a strong international
vote of confidence in LCT and supports the potential and safety of LCT's
products to significantly address the global diabetes epidemic," said Dr Tan.
LCT is the first and only company in the world to have established the
necessary current requirements for animal cell transplants - through a
biocertified pig herd, GMP cell processing facilities and now the accredited diagnostic
monitoring laboratory.
LCT is particularly grateful for the support of a Growth Services Fund grant
from New Zealand Trade & Enterprise, which assisted in attaining this
certification.
DiabeCell is a porcine islet cell transplant therapy for the treatment of
insulin-dependent diabetes. The pig cells produce insulin and help regulate
blood glucose levels appropriate to the amount of glucose detected in the blood
stream of the diabetic recipient.
Paul Tan CEO
Paris Brooke General Manager - LCT
Note: Xeno-based cell products: The use of natural living animal cells for
human treatment.
About Living Cell Technologies: _http://www.lctglobal.com/_
(http://www.lctglobal.com/)
Living Cell Technologies Ltd (ASX: LCT) develops live cell therapy products
to treat life threatening human diseases. The ASX listed, vertically
integrated company focuses on developing treatments where healthy living cells are
injected into patients to replace or repair damaged tissue, without requiring
the use of toxic drugs to prevent rejection.
About International Accreditation New Zealand:
International Accreditation New Zealand (IANZ) is a crown entity established
under the Testing Laboratory Registration Act, 1972. It is the national
authority for the accreditation of testing and calibration of laboratories,
inspection bodies and radiology services. IANZ represents New Zealand in the
International Laboratory Testing Cooperation (ILAC), which groups nationally
recognised accreditation authorities worldwide. Accreditation by IANZ ensures that
the laboratory test reports and certificates are accepted in forty-nine
economies, including the US, Canada, United Kingdom, Australia and New Zealand.
Mutual Recognition Arrangements link sixty-one accreditation authorities
within these economies to provide an international network of accredited
laboratories and inspection services.
Contact: Paris Brooke
Kureczka/Martin Associates
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