Two international charitable foundations, New Zealand-based Cure Kids and U.S.-based Children with Diabetes Foundation, have each pledged to provide US$140,000 to fund the final two patients in a Phase II clinical trial in New Zealand that has the potential to transform the treatment of Type 1 diabetes.
The trial is testing DIABECELL as a treatment for Type 1 diabetes and has been developed by Living Cell Technologies, an Australian company domiciled in New Zealand. DIABECELL is designed to help normalise the lives of people with unstable Type 1 diabetes, especially those suffering from life-threatening episodes of unaware hypoglycaemia. Tiny DIABECELL microspheres containing live islet cells are implanted into a patient's abdomen using a simple laparoscopic procedure.
Once implanted, DIABECELL works by self-regulating and efficiently secreting insulin in response to the patient's changing glucose levels. DIABECELL islets are protected from the body's immune response by LCT's breakthrough proprietary encapsulation technology, so DIABECELL patients do not require any immunosuppression.
DIABECELL was discovered by LCT's Medical Director and founder Professor Bob Elliott when he was working as a paediatrician and in response to treating a two year old boy with Type 1 diabetes. This event began his journey to find a cure for diabetes in children.
Vicki Lee, CEO of Cure Kids said: "We've been closely monitoring and watching the work of LCT and have been very impressed with the outcome of the research to date. We are strong supporters of the company's efforts to find an effective treatment for this life-threatening disease, and share Professor Elliott's vision to make this available to children and adults alike."
Sonia Chritton, President of Children with Diabetes Foundation added: "We view this contribution as a critical part of our role in supporting families and people living with diabetes globally. Children with Diabetes is anxiously awaiting the results of LCT's Phase II clinical trials. We are happy to provide support for a complete examination of the DIABECELL dose ranges. This is critical for determining the dose that delivers optimal patient benefit. LCT is the world leader in xenotransplantation, offering hope for the many people suffering from Type 1 diabetes."
Prof. Bob Elliott, LCT's Medical Director and founder added: "These grants will allow LCT to complete the dose-finding part of our research as we seek the dose regimen that provides the optimal patient benefit. These two patients will join two others, each receiving an implant of DIABECELL at a dose of 5,000 IEQ/kg. This will complete our exploration to determine the minimum effective dose."
"Both of these leading charitable foundations are focused on diseases that afflict children. Having the support of these foundations who understand better than anyone the need for new and improved treatments for Type 1 diabetes is very satisfying and a validation of the progress LCT has made with DIABECELL. These foundations appreciate that the research being conducted today offers hope for our children in the future. We are very thankful for their support."
To date, twelve of the approved New Zealand patients with unstable insulin dependent diabetes have received this ground-breaking treatment, which has been shown to safely improve diabetes management and reduce or eliminate episodes of life-threatening low blood glucose levels. The dramatic results to date show DIABECELL's ability to ameliorate this serious complication of diabetes, known as hypoglycaemic unawareness, is an important potential benefit to patients.
LCT's current New Zealand Phase II trial will be concluded after the treatment of these two patients and their subsequent evaluation. This signifies an exciting and significant milestone for LCT and takes the transformational treatment for diabetes one step closer to helping the millions of people worldwide with the disease.
The first four patients in the Phase II trial received one implant of DIABECELL at a dose of 10,000 islet equivalents per kilogram body weight (IEQ/kg). A second group of four patients has received a higher dose of 15,000 IEQ/kg. In the third group of two patients, a high dose of 20,000 IEQ/kg was administered. The fourth group of four patients will receive the dose of 5,000 IEQ/kg.