Clinical Benefit for All Patients in Diabetes Tria
Living Cell Technologies Reports Clinical Benefit for All Patients in Diabetes Trial
July 22, 2008, Melbourne, Australia and Auckland, New Zealand. Living Cell Technologies Limited (ASX:LCT; OTCQX: LVCLY) today released further interim results describing clinical benefit in all patients who have received implants of DiabeCell®, the Company’s encapsulated porcine islet cells for the treatment of type 1 diabetes.
Six patients with insulin dependent diabetes have now received DiabeCell® implants. Five patients in the first group received the lowest dose of 5,000 islet equivalents (IEQ/kg) and two of them have received a second implant of the same dose. To date, no remarkable adverse events have occurred during the trial, which has enabled LCT to meet clinical milestones in relation to safety for up to 12 months follow up.
The trial has been expanded to a second group of five patients and the sixth patient in the trial has been implanted with the higher dose of 10,000 IEQ/kg.
Professor Elliott, LCT Medical Director said, “At this stage in the DiabeCell® trial clinical benefit has been observed in all five patients receiving the lowest dose which has far exceeded our expectations. In the first group, following DiabeCell® implants we have seen reductions in daily insulin requirements ranging from 23% to as much as 100% while maintaining good control of blood glucose levels in four out of five patients”.
“In patients who have had the longest follow-up period, we have seen reductions in insulin requirements of 24% and 54% being maintained at 12 and 11 months in the first two subjects respectively. We have also reported the detection of porcine insulin in blood samples of patients confirming that the implanted islets remained functional at 6 months and 11 months after the first implant.”
Improvement in blood glucose control in the group is reflected by the Mean glycated hemoglobin (HbA1c) level which fell from 8.5% pre-implant to 6.8% at the time of last measurement
The lowest patient response was a 10% maximum reduction in daily insulin requirement. The patient’s HbA1c dropped markedly however, from 10.1 to 7.3 following the implant. This result indicates better blood glucose control after treatment with DiabeCell® and continuous glucose monitoring has confirmed this.
“The swings in blood glucose levels and his diabetes control have improved dramatically not with more but with a smaller insulin dose and the lowest dose of DiabeCell®.” said Professor Elliott.
“The magnitude and duration of clinical responses observed with the lowest dose leads us to expect that higher doses of DiabeCell® will support greater and longer term reductions in the insulin needs of patients.”
Dr Paul Tan, LCT CEO, said, “The positive clinical results have prompted us to expand our pig breeding facilities to meet supplies of DiabeCell® for advancing our clinical and commercial programs internationally.”
About the trial
· The trial is under way in Moscow and is intended to enroll a total of ten patients having type 1 diabetes who have given informed consent for their participation
· The trial is being monitored by a U.S.-based contract research organization (CRO)
· Patients receive one implantation of DiabeCell® at the lowest dose anticipated to demonstrate a measureable improvement in glucose control and need for insulin (among other parameters) at the commencement of the treatment and again following an additional implant six months later
· The following parameters are being measured pre- and post-implant:
Daily insulin dose
Continuous glucose monitoring
Haemoglobin A1c (to indicate average blood glucose over a two-month period)
Porcine insulin in blood after a standard stimulus
Frequency of episodes of low blood glucose