Diabetes Clinical Trial in New Zealand
Living Cell Technologies
LCT Informed of Progress for Decision on Diabetes Clinical Trial in New Zealand
June 26, 2008 – Melbourne, Australia and Auckland, New Zealand - Living Cell Technologies Limited (ASX:LCT; OTCQX: LVCLY) today announced that it has received a letter from the New Zealand Minister of Health, the Honorable David Cunliffe, indicating that he has sought independent advice from the National Health Committee (NHC) by 8 August 2008, on LCT’s application to conduct a Phase I/IIa clinical trial with DiabeCell® in New Zealand.
The NHC is a Ministerial advisory committee that the Minister can seek advice from to complete the statutory requirements of his decision making process on the authorization of LCT’s application. Prior to this stage, LCT had obtained and submitted to the Minister approvals from the Regional Ethics Committee, the Gene Technology Advisory Committee, International
Accreditation New Zealand and Medsafe, the regulatory body that approved the manufacture for human use of encapsulated porcine cells (DiabeCell®) under Good Manufacturing Practice standards.
DiabeCell® is the Company’s encapsulated porcine insulin-producing cells currently in development for the treatment of insulin dependent type 1 diabetes without the use of immunosuppressive drugs. Dr Paul Tan, LCT Chief Executive Officer, said, “LCT is pleased with the stated time frame and is committed to assisting the Minister and the NHC with any further information that may be required to ensure that the deadline is met. LCT sees this as a step forwards for its efforts to include New Zealand in the Company’s international clinical trials programme”.