Mar 30 2010
Living Cell Technologies Limited (ASX:LCT) (OTCQX:LVCLY), 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 percent 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>
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.
Source Living Cell Technologies
www.lctglobal.com