DiabeCell Phase IIb trial initiated following strong interim Phase IIa results
Results from an interim analysis of Living Cell Technologies' (LCT) Argentinian Phase I/IIa trial of DiabeCell, encapsulated porcine islets for the treatment of unstable Type I diabetes, have 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 trial, which is ongoing, involves eight patients split into two groups of four. Group one received two 5,000 IEQ/kg doses of DiabeCell and group two received two 10,000 IEQ/kg doses. In both groups, the second dose was implanted 12 weeks after the first. At the time of this 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.
In the second group of patients (those receiving 10,000 IEQ/kg) the most significant clinical benefits were:
â¢ average insulin dose reduced by 20 per cent;
â¢ a reduction of HbA1c from a pretransplant average of 8.6 per cent to an average of 6.7 per cent at 12 weeks following the second implant; and
â¢ up to 70 per cent reduction in unaware hypoglycaemic events.
This interim analysis has been used to inform a Phase IIb study, which has begun patient recruitment in Argentina. The trial is designed to demonstrate the clinical benefits of DiabeCell in unstable Type I diabetes. Twenty patients will receive two implants of 10,000 IEQ/kg, with the second implant occurring 12 weeks after the first.
LCT remains on track to meet its goal of completing clinical trials of DiabeCell by 2015 and having a product commercially available by 2016. DiabeCell is owned by the joint venture company, Diatranz Otsuka, in which LCT and Otsuka Pharmaceutical Factory both have a 50 per cent interest.