[ASC-media] LCT approval manufacture xeno products
pbrooke at lctglobal.com
Tue Dec 19 00:33:14 CET 2006
LCT granted approval to manufacture xeno products for human use
Melbourne, December 19, 2006/ MediaNet International/ -
Living Cell Technologies Ltd (ASX:LCT) today announced it has received a
licence from the New Zealand Government to manufacture a novel animal cell
product for humans under Good Manufacturing Practice (GMP).
The NZ regulator MedSafe issued a formal letter to LCT recommending a
Licence to Manufacture Medicines be issued which will allow the use of its
xenotransplant products in human patients. The facility will be used to
manufacture cell therapy products including DiabeCellR.
The scope of the GMP accreditation includes the company's proprietary
micro-encapsulation process and also the manufacture and preparation of free
islets from neo-natal pigs.
"GMP accreditation is a significant milestone and is a necessary requirement
to begin LCT's clinical trial program," said LCT Managing Director, Dr Paul
"As far as we know, LCT possesses the only accredited GMP facility to make
xeno porcine products and will be able to manufacture its products in
accordance with the regulations of any regulatory jurisdiction throughout
"This is a strong vote of confidence in xeno-based cell research and the
potential of LCT's products to significantly address the global diabetes
epidemic," said Prof Bob Elliott, Medical Director.
This significant milestone is the first and most fundamental part in a three
step process to obtain approval for a human clinical trial in New Zealand in
2007. LCT must now receive a 'Recommend for Approval' from MedSafe to
conduct the clinical trial and final ethics approval.
The accreditation has been granted after a rigorous audit process.
DiabeCellR is a porcine islet cell transplant therapy for the treatment of
insulin-dependent diabetes. The neo-natal 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.
After a preliminary consultation with Medsafe NZ, LCT submitted an
application earlier this year to conduct the DiabeCellR clinical trial on
eight long standing Type 1 (insulin-dependent) diabetics, with the intent of
commencing the recruitment phase of the trial this year.
Further information: Dr Paul Tan, Managing Director - NZ, Mobile: +61 402
About LCT: Living Cell Technologies Ltd (ASX: LCT) develops live cell
therapy products to treat life threatening human diseases. Healthy living
cells are injected into patients to replace or repair damaged tissue,
without the use of toxic drugs to prevent immuno-rejection.
Living Cell Technologies Ltd
Suite 2.11, 737 Burwood Road
Hawthorn VIC 3122
Tel: +61 3 9813 5501
Fax: +61 3 9813 5502
Mob: 0407 715 574
Email: pbrooke at lctglobal.com
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