- LCT awarded world-first IANZ accreditation for xenotransplantation laboratory
- Major step toward commencing DiabeCell® clinical trials in New Zealand in 2007
- Xenotransplant laboratory is accredited to test and monitor for a range of animal & human viruses and its lab reports will be accepted by forty-nine countries including: the US, UK. and Canada.
Living Cell Technologies Ltd (ASX:LCT) 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.
Further Information: Images available on request to firstname.lastname@example.org
Paul TanCEOTel: +64 9 270 7941Mobile: +61 402 716 984 Paris Brooke General Manager - LCT Tel: +61 3 9813 5501 Mobile: + 61 407 715 574
Note: Xeno-based cell products: The use of natural living animal cells for human treatment.
About Living Cell Technologies: 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.