Living Cell Technologies has provided a penultimate update regarding the three-year follow up of its Phase I/IIa clinical trial of its Diabecell treatment in insulin-dependent diabetics in Russia.
The data analysis has confirmed that the trial has met its end points of demonstrating safety and tolerability. In addition, the treatment has shown proof of principle of efficacy in humans with insulin-dependent (type 1) diabetes.
Diabecell is LCT’s treatment designed to normalise the lives of people with insulin-dependent diabetes. Diabecell comprises encapsulated porcine insulin-producing cells (islets) 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.
Living Cell Technologies said that these results have been accepted for oral presentation at the scientific meeting of the American Diabetes Association in June. These positive data, taken together with positive progress in LCT’s Phase II trial in New Zealand, provide encouragement to progress Diabecell further towards commercialisation.
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.
In the trial the 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.
Reportedly, all trial patients are expected to 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.
Bob Elliott, medical director at LCT, said: “We are pleased that our treatment has shown so far to be safe and well tolerated. We are encouraged that we have demonstrated that Diabecell may be safely administered up to three times and that we have seen evidence of continuing efficacy exemplified by the patients clearly showing reduced HbA1c levels as well as the daily dose of insulin injections, with better control over their blood glucose levels. Patients volunteered that they sensed greater well being.”
Paul Tan, CEO of 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.”