SOURCE: Living Cell Technologies

September 12, 2007 09:40 ET

Living Cell Technologies Receives Ethics Approval for DiabeCell® Phase I/IIa Clinical Trial in New Zealand

Proprietary Pig Cell Implant Technology

AUCKLAND, NEW ZEALAND and MELBOURNE, AUSTRALIA--(Marketwire - September 12, 2007) - Living Cell Technologies Ltd. (ASX: LCT) (PINKSHEETS: LVCLY) today announced that it has received New Zealand Regional Ethics Committee approval to commence a Phase I/IIa clinical trial of its DiabeCell® product for type I diabetes.

DiabeCell® is a porcine islet cell product for the treatment of type I (insulin-dependent) diabetes. The pig cells are injected into the peritoneal cavity to produce insulin and help regulate blood glucose levels appropriate to the amount of glucose detected in the blood stream of the diabetic recipient. DiabeCell® has been uniquely developed to eliminate the need for immunosuppression. The natural cells are coated in a proprietary alginate gel that forms a tiny capsule around the cells and prevents the patient's immune system from destroying the transplant.

"Intra-peritoneal islet cell transplantation has the potential to improve type 1 diabetes mellitus and ultimately prevent the life shortening consequences of chronic diabetes, which cannot be achieved by conventional insulin treatments," said Living Cell Medical Director, Professor Bob Elliott. "The global market for type 1 diabetes is estimated at 24 million people."

LCT intends to conduct the New Zealand Phase I/IIa clinical trial of its DiabeCell® product on eight long-standing type 1 (insulin-dependent) diabetics. The clinical trial is expected to be approximately 12 months in duration. The trial will be conducted at a New Zealand hospital and involves the simple injection of encapsulated islets into the abdomen of the diabetic patients. It is anticipated that the trial will start in late 2007 and will then be followed by a larger pivotal trial.

Undertaken over the last nine months, the full ethics review included assessment by international experts across ethical and cultural considerations, safety, public health and scientific data. MedSafe (the NZ regulator), the Gene Technology Advisory Committee (GTAC) and the regional ethics committee have all advised the New Zealand Minister for Health of their approval for the clinical trial to proceed. The Minister's formal approval of Living Cell's request to commence the Phase I/IIa clinical trial is expected within the next few weeks.

The ethics committee considered key areas such as adequate patient consent, the potential contribution to knowledge and risk/benefit ratio of the trial, rare adverse events and LCT's unique system for managing potential perceived risk to the trial population. Judgement of risk has been based upon testing standards required by the US Food and Drug Administration (FDA).

"LCT has worked closely with the regulatory authorities to establish the framework for conducting clinical trials with pig cells to a new benchmark. In doing so, LCT has built up considerable commercialization capability and know-how that are essential for taking DiabeCell® to the clinic and market. We can now move forward in confidence that our clinical trial strategy has undergone thorough assessment externally," said Dr. Paul Tan, Chief Executive Officer.

The Company's DiabeCell® product is currently in a Phase I/IIa clinical trial in Moscow in six type 1 (insulin-dependent) diabetics. Recipients in this first trial are being given the lowest clinically effective dose to demonstrate safety with dosing to be repeated for additional clinical benefit. Follow up monitoring of these patients will continue for 12 months.

About Living Cell Technologies: www.lctglobal.com

Living Cell is developing live cell therapy 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 also offers medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.

LCT has a US American Depositary Receipt program, enabling US residents to purchase LCT stock. To purchase ADRs in LCT, please contact your broker (PINKSHEETS: LVCLY) (CUSIP Number: 53838R107). More information about investing in the LCT ADR program can be obtained directly from Violet Pagan, Vice President Depositary Receipts at the Bank of New York, by email: vpagan@bankofny.com.

Background Information:

Scientific papers relating to DiabeCell® are available for download on the LCT website at http://www.lctglobal.com/scientificarticles.php

LCT disclaimer

This document contains certain forward-looking statements, relating to LCT's business, which can be identified by the use of forward-looking terminology, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations regarding the approval and commercialization of product candidates could be affected by, among other things, unexpected clinical trial results; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects.

Contact Information

  • Further information: www.lctglobal.com
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    +61 3 9886 0247

    Company
    Dr. Paul Tan
    CEO
    Tel: +61 402 716 984

    Investor / public relations
    Mark Jones
    Global Consulting Group
    Tel: +1 646 284 9414