LCT Informed Of Progress For Decision On Diabetes Clinical Trial In New Zealand

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 27 Jun 2008 - 5:00 PDT

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Living Cell Technologies Limited (ASX: LCT) (PINKSHEETS: LVCLY) 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."

About Living Cell Technologies

Living Cell is developing cell-based products to treat life threatening human diseases. The Company owns a biocertified pig herd that it uses as a source of cells for treating diabetes and neurological disorders. For patients with Type 1 diabetes, the Company transplants microencapsulated islet cells so that near-normal blood glucose levels may be achieved without the need for administration of insulin or at significantly reduced levels. The company entered clinical trials for its diabetes product in 2007. For the treatment of Huntington's disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells that deliver beneficial proteins and neurotrophic factors to the brain. Living Cell's technology enables healthy living cells to be injected into patients to replace or repair damaged tissue without requiring the use of immunosuppressive drugs to prevent rejection. Living Cell also offers medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.

http://www.lctglobal.com

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Living Cell Technologies