The trial, which commenced in June 2007, is reported for the eight patients. The patients, between 21 and 68 years of age with insulin-dependent diabetes have received between one and three implants of DIABECELL?® with only minor adverse events. Blood samples taken from patients over the past 34 months have tested negative for any pig-to-human transmission of diseases. Six of the eight patients have shown improvements in blood glucose control as reflected by reduction in glycated haemoglobin (HbA1c %) levels and reduction of the required daily dose of insulin injections. Two patients discontinued insulin injections entirely; the longest period was for a span of 14 weeks. The trial was conducted in the Sklifosovsky Institute Moscow.
All trial patients will continue to be monitored to establish the duration of clinical benefit and safety. LCT is investigating the possibilities of conducting additional trials in other jurisdictions. LCT also recently reported that DIABECELL?® has also progressed to the next stage if its Phase II studies in New Zealand having received approval from the New Zealand Data Safety and Monitoring Board in late March to advance to implants at higher doses.
Dr Paul Tan, Chief Executive Officer for LCT, said, "We are pleased with the progress we are making with DIABECELL?® in our trials in Russia and New Zealand. Our Phase II trial in New Zealand will help us to determine the optimum dosing regimen. We are thus pleased to be making positive progress towards commercialisation."
SOURCE Living Cell Technologies Limited