LCT to extend NZ diabetes trial

Xenotransplantation specialists Living Cell Technologies (LCT) announced today that promising results from a Phase II clinical trial of its cell implant Diabecell in diabetes patients in New Zealand has prompted the country’s health regulator to approve the addition of four more patients.

LCT reported recently that in the current trial of eight New Zealand patients with unstable diabetes, all have seen the reduction or elimination of episodes of low blood glucose levels, a potentially life threatening condition associated with diabetes known as hypoglycaemic unawareness.

Diabecell is a porcine (pig), insulin producing cell product for the treatment of Type 1 diabetes mellitus. Cells, or islets are implanted into the abdomen of patients where they regulate the secretion of insulin. LCT said that its unique encapsulation technology precludes the need for immunosuppression after implantation.

The first four patients taking part in the New Zealand trial received an implant of Diabecell at the dose of 10,000 islet equivalents per kilogram of body weight (IEQ/kg) with no adverse effects reported. Four other patients were each given a higher dose of 15,000 IEQ/kg, also with no adverse effects. The third group, approved today by New Zealand’s Regional Ethics Committee and the Data Safety and Monitoring Board, will be given Diabecell implants at the dose of 20,000 IEQ/kg.

LCT Medical Director Professor Bob Elliot said that this would “enable a future assessment of a possible commonly seen plateau effect in dosing which will allow us to understand dosing efficiencies for various patient indications.”

The company’s shares closed marginally up today at $0.225.