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Fact sheet
The following fact sheets provide a summary of our current business and research pipeline.
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Fact sheet

The following fact sheet provides a summary of our current business and research pipeline.

Development to date

DIABECELL® is currently in late-stage clinical trials.
 

Previous clinical trials are outlined below:
 

Phase IIa safety and efficacy study (Argentina)
The ongoing trial involves eight patients split into two groups of four. Group one received two 5,000 IEQ/kg doses of DIABECELL (islet equivalents per kilogram of body weight). Group two received two 10,000 IEQ/kg doses of DIABECELL. In both groups, the second dose was implanted 12 weeks after the first.

 

Results of the interim analysis were announced in November 2012. At the time of the interim analysis, group one patients were at 24 weeks follow-up after the second transplant, and group two patients were at 12 weeks follow-up after the second transplant. 

 

The results clearly demonstrated a clinically significant reduction in HbA1c, insulin dose and unaware hypoglycaemia, with greater benefit being seen in the patient group receiving the higher dose of DIABECELL. The most significant clinical benefits were: 
                              -  Average insulin dose reduced by 20%
                              -  A reduction of HbA1c from a pre-transplant average 8.6% to an average 
                                 of 6.7% at 12 weeks following the second implant. 
                              -  Up to 70% reduction in unaware hypoglycaemic events. 

 

Phase IIa dose finding study (New Zealand)
This completed trial involved 16 patients with type 1 diabetes treated at Middlemore Hospital in Auckland. Patients were treated with different levels of islet cells: 5,000, 10,000, 15,000 and 20,000 IEQ/kg body weight. At 52 weeks, HbA1C levels were reduced in the 5,000, 10,000 and 20,0000 IEQ/kg treatment groups, compared with baseline. A statistically significant reduction in the number of unaware hypoglycaemic episodes was observed in both the 5,000 and 10,000 IEQ/kg groups. A reduction in insulin use was evident in all treatment groups, with marked mean reductions in the 5,000 and 10,000 IEQ/kg groups. The islet cell implants were well tolerated in all patients. Quality of life questionnaires revealed a positive impact of treatment.

 

Phase I/IIa safety study (Russia)
A total of eight patients received DIABECELL implants of varying dose strength. Some patients received multiple doses.
 

Data analysis confirmed that the trial successfully met its endpoints of demonstrating safety and tolerability. In addition, the trial showed proof of principle of efficacy in humans with insulin-dependent (type 1) diabetes. 
 

Six of the eight patients on the trial demonstrated improvements in blood glucose control as reflected by reduced HbA1c levels and reduced dose of daily insulin injections. Two patients discontinued insulin injections entirely for up to 32 weeks. 

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