Living Cell Technology to begin phase II diabetes trial

Xenotransplantation specialist, Living Cell Technologies, has been given the go-ahead by New Zealand regulators to conduct the next stage of a phase II trial of its Diabecell implant to treat type I diabetes.

The New Zealand Data Safety and Monitoring Board made a positive assessment of the first four patients to receive the Diabecell implant, which consists of encapsulated insulin-producing pig cells.

These patients have unstable diabetes which includes a condition known as hypoglycaemic unawareness, which is where the individual doesn't experience the normal warning signs of low blood sugar, increasing the risk of complications such as loss of consciousness or even coma.

They each received a single Diabecell implant, which consisted of 10,000 islet equivalents per kilogram of body weight (IEQ/kg).

One patient in the trial reduced daily insulin doses by 25 per cent and had their hypoglycaemic unawareness eliminated.

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," said Professor Bob Elliott, Living Cell Technologies medical director, in a statement.

"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."

The new trial will be conducted by Dr John Baker, principle investigator and diabetes specialist based at Middlemore Hospital in Auckland, New Zealand.

In this trial, four new patients will be given a higher dose of 15,000 IEQ/kg, with interim results due in October 2010 and the full study reported in 2011.

Living Cell Technologies' (ASX:LCT) has gained 2% in its stock price following the announcement, which comes on the back of a 42% gain since the beginning of March.