From www.lctglobal.com newslettter:
Living Cell Technologies Receives Approval to Progress its Human Phase II Trial of DIABECELL® treatment for Diabetes to Next Stage with Encouraging Data
Living Cell Technologies Limited, a global company pioneering the development of a cell implant to treat diabetes, today announced that it has received approval to advance to the next phase of its New Zealand Phase II human clinical trial with its groundbreaking DIABECELL®. The approval follows a positive assessment from the New Zealand Data Safety and Monitoring Board of the first four patients to receive its DIABACELL® implants.
Prof. Bob Elliott, LCT Medical Director said, "We are absolutely delighted that we have been able to demonstrate significantly improved control of blood glucose in this group of patients with difficult to control or unstable diabetes. Using the current smaller dose of DIABECELL®, two patients so far have eliminated or reduced life-threatening episodes of hypoglycaemic unawareness, a serious complication without warning symptoms and which can lead to accidents and coma."
DIABECELL® is LCT's treatment designed to normalise the lives of people with insulin-dependent diabetes. DIABECELL® comprises encapsulated porcine islets (insulin-producing cells) 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. Importantly, LCT's breakthrough proprietary encapsulation technology means that patients receiving DIABECELL® treatment do not require immunosuppressant drugs after implantation. The trial is being conducted by Dr John Baker, Principal Investigator and diabetes specialist based at Middlemore Hospital in Auckland, New Zealand.
Dr Paul Tan, Chief Executive Officer LCT said, "The results reported earlier in the eight-patient Phase I/IIa trial in Russia are now supported by the responses we see in New Zealand patients who have much more unstable diabetes. In the next stage of this New Zealand trial we will be looking to ascertain additional benefits DIABECELL® could deliver with a higher dose."
The first four New Zealand patients were given a single implant of 10,000 islet equivalents/kg body weight (IEQ/kg), the dose similar to that given to some patients in the Phase I/IIa trial in Russia.
Patients in the New Zealand trial have unstable diabetes which includes frequent and potentially life threatening episodes of hypoglycaemia. In the first patient treated in NZ, who has been followed for 24 weeks after implant, daily insulin dose has been reduced by 25% and hypoglycaemic unawareness has been completely eliminated, giving an early indication of success. Further details of all of the trial results will become known once the trial is unblinded on completion.
In the next phase of this trial, four new patients will be given a higher dose of 15,000 IEQ/kg, by July 2010 with interim results due in October 2010 and final unblinding and reporting of results after one year follow up. LCT is now investigating the possibilities of conducting additional trials in other jurisdictions.
The protocol for the New Zealand trial of DIABECELL® implants was approved by the NZ Minister of Health in June 2009 following international peer review of LCT's DIABECELL® clinical programme. The protocol requires patients to be monitored for eight weeks before receiving the implant. All recipients of DIABECELL® implants will be followed up intensively for a year and less frequently thereafter. Details of the trial are available at http://clinicaltrials.gov/ct2/show/NCT00940173?term=porcine+islets&rank=1.
Insulin-dependent type I diabetes is caused by the autoimmune destruction of insulin producing cells. Presently, intensive treatment with insulin injections is necessary to normalize blood glucose to prevent future eye, kidney, nervous system and cardiovascular complications. Unfortunately, intensive insulin therapy causes swings in blood glucose levels and life threatening hypoglycaemic unawareness. The latter is a condition when no warning symptoms are felt when blood glucose falls to low levels that can impair consciousness resulting in accidents and coma. (www.diabetesnet.com and www.diabetesselfmanagement.com). Hypoglycaemic unawareness is related to the loss of the normal stress response to low blood glucose levels.
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