Living Cell Technologies Limited, a global company pioneering the development of a cell implant to treat diabetes, reported that the Minister of Health has approved an addition to the New Zealand phase II clinical trial of Diabecell to include more patients. To date, eight insulin dependent diabetes patients have received the implants Diabecell, LCT’s encapsulated porcine islets, and now another four patients will be enrolled into the dose ranging trial. The expansion of the New Zealand study has also been approved by the Regional Ethics Committee and the Data Safety and Monitoring Board. The Minister stated that he is satisfied that amending the original approval to include more patients will add further rigour to the study and may provide valuable additional information.
LCT has recently reported that in the current trial of eight New Zealand patients with unstable diabetes, all have shown the benefit of reduction or elimination of episodes of low blood glucose levels that are often life-threatening. The dramatic results to date showing Diabecell’s ability to ameliorate this serious complication of diabetes, known as hypoglycaemic unawareness, are one key indicator of potential benefit to patients.
The first four patients received one implant of Diabecell at the dose of 10,000 islet equivalents per kilogram body weight (IEQ/kg) without any reported adverse events attributable to the treatment. A second group of four patients has received a higher dose of 15,000 IEQ/kg, also with no significant adverse events attributed to the treatment. At this time, the follow up period is too short to assess efficacy with this second group.
The safety profile of Diabecell continues to be confirmed and therapeutic benefit remains promising as the Company progresses with its dose ranging trials, aimed at identifying the most efficient dose to achieve optimal efficacy.
Prof Bob Elliott, LCT Medical director said: “This approval allows us to administer up to 20,000 IEQ/kg in four patients which I expect is likely to be the maximum consideration for a single dosing. It will 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. ”
Dr Paul Tan, NZ chief executive officer LCT added: “The Minister’s approval to expand the New Zealand trial is part of LCT’s clinical and commercial development plan to see Diabecell advance to market. This additional patient information will be important when analysing the data to assess the necessary doses to meet various endpoints relevant to patients with unstable 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. LCT's breakthrough proprietary encapsulation technology, IMMUPEL, means that patients receiving Diabecell treatment do not require immunosuppression after implantation.
Living Cell Technologies (LCT) is developing cell-based products to treat life threatening human diseases. The Company owns a bio-certified pig herd that it uses as a source of cells for treating diabetes and neurological disorders.