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NZ permits LCT to progress with Diabecell human trial

Singapore, Mar 30, 2010: Living Cell Technologies (LCT), a New Zealand-based company pioneering the development of a cell implant to treat diabetes, received approval to advance to the next phase of its New Zealand phase II human clinical trial with its groundbreaking Diabecell. The approval follows a positive assessment from the New Zealand Data Safety and Monitoring Board of the first four patients to receive its Diabecell implants.

Prof Bob Elliott, LCT Medical Director said, "We are absolutely delighted that we have been able to demonstrate significantly improved control of blood glucose in this group of patients with difficult to control or unstable diabetes. Using the current smaller dose of Diabecell, two patients so far have eliminated or reduced life-threatening episodes of hypoglycaemic unawareness, a serious complication without warning symptoms and which can lead to accidents and coma."

Diabecell is LCT's treatment designed to normalize the lives of people with insulin-dependent diabetes. Diabecell comprises encapsulated porcine islets (insulin-producing cells) that are implanted into the abdomen of patients using a simple laparoscopic procedure, and work by self-regulating and efficiently secreting insulin in the patient's body. Importantly, patients receiving Diabecell treatment do not require immunosuppressant drugs after implantation. The trial is being conducted by Dr John Baker, Principal Investigator and diabetes specialist based at Middlemore Hospital in Auckland, New Zealand.
 
 Dr Paul Tan, Chief Executive Officer of LCT said, “The results reported earlier in the eight-patient phase I/IIa trial in Russia are now supported by the responses we see in New Zealand patients who have much more unstable diabetes. In the next stage of this New Zealand trial we will be looking to ascertain additional benefits Diabecell could deliver with a higher dose.”

The protocol for the New Zealand trial of Diabecell implants was approved by the NZ Minister of Health in June 2009 following international peer review of LCT's Diabecell clinical program.

© BioSpectrum Bureau
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