LIVING CELL: ‘CLINICAL BENEFIT IN ALL TYPE 1 DIABETES PATIENTS’
July 24th 2008 01:09
Tuesday July 22, 2008
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LIVING CELL TECHNOLOGIES
Living Cell says interim results show clinical benefit in all type 1 diabetes patients dosed with Diabecell encapsulated porcine islet of Langerhans cells.
Living Cell medical director Prof Bob Elliott said “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 percent to as much as 100 percent while maintaining good control of blood glucose levels in four out of five patients,” Prof Elliott said.
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.
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.
The company said no remarkable adverse events had occurred during the trial, enabling it to meet clinical milestones in relation to safety for up to 12 months follow up.
“In patients who have had the longest follow-up period, we have seen reductions in insulin requirements of 24 percent and 54 percent being maintained at 12 and 11 months in the first two subjects respectively,” Prof Elliott said.
“We have also reported the detection of porcine insulin in blood samples of patients confirming that the implanted islets remained functional at six months and 11 months after the first implant,” he said.
“Improvement in blood glucose control in the group is reflected by the mean glycated hemoglobin (HbA1c) level which fell from 8.5 percent pre-implant to 6.8 percent at the time of last measurement,” Prof Elliott said.
“The lowest patient response was a 10 percent maximum reduction in daily insulin requirement,” he said.
“The patient’s HbA1c dropped markedly however, from 10.1 to 7.3 following the implant,” Prof Elliott said.
“This result indicates better blood glucose control after treatment with Diabecell and continuous glucose monitoring has confirmed this,” he said.
“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,” Prof Elliott said.
“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,” Prof Elliott said.
Living Cell’s chief executive officer Dr Paul Tan said the results prompted an expansion of pig breeding facilities to supply Diabecell for clinical and commercial programs.
The trial is under way in Moscow and is intended to enroll a total of 10 patients with type 1 diabetes who have given informed consent for their participation and is being monitored by a US-based contract research organization.
Patients receive one implantation of Diabecell at the lowest dose expected 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 parameters measured pre and post-implant include 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; and patient satisfaction.
Living Cell was unchanged at 20 cents.
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