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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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