Living Cell Technologies' Diabetes Clinical Trial Authorized by New Zealand Government
24 June 2009 - 11:00PM
PR Newswire (US)
SYDNEY and AUCKLAND, New Zealand, June 24 /PRNewswire/ -- Living
Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced
that the New Zealand Minister of Health, the Honourable Tony Ryall,
has authorized LCT's New Zealand Phase I/IIa clinical trial of
DIABECELL(R) for insulin dependent diabetes. The authorization
confirms the conditions announced on 19 June 2009. One condition of
the new authorization limits participation in the trial to patients
with poorly controlled (brittle) diabetes. The remaining conditions
are procedural rather than substantive in nature and LCT and the
Middlemore Hospital clinical team conducting the trial, have
requested the Regional Ethics Committee formally accept the changes
required by the Minister. LCT CEO Dr Paul Tan said: "We are pleased
that the conditions have been finalized and LCT looks forward to
commencing the trial within the next two months with the acceptance
of the changes by the Ethics Committee." Professor Bob Elliott, LCT
Founder and Medical Director added: "The New Zealand diabetes trial
is another major milestone for LCT. With two diabetes patients not
requiring insulin following implants with encapsulated pig islet
cells in our first study in Russia, we expect to see further
benefit in more patients as we use higher doses of DIABECELL(R) in
the New Zealand trial." LCTs Phase I/IIa clinical trial in Russia
started with a low dose of DIABECELL(R). In May 2009 LCT reported
preliminary data showing sustained long term clinical benefit in
patients treated with the DIABECELL(R) implant with no remarkable
adverse events. Remarkably, two of seven patients given implants
are now off insulin injections. The New Zealand trial allows LCT to
extend its Phase I/IIa clinical data with eight patients, four of
whom are to receive double the initial dose used in Russia followed
by four patients to receive triple the dose. Dr John Baker,
Clinical Director and Diabetes Physician at Middlemore Hospital,
Auckland, who will be conducting the trial said, "There are many
patients with poorly controlled diabetes who would qualify for this
trial." DIABECELL(R) is designed to normalize blood glucose levels
in type 1 diabetes sufferers. DIABECELL(R) comprises encapsulated
porcine insulin-producing cells which can be administered without
the need to use immunosuppressive drugs. Type 1 diabetes occurs
when the body's own immune system destroys the insulin-producing
cells of the pancreas (called beta cells). Five to 10 percent of
the more than 200 million diabetics worldwide have insulin
dependent type 1 diabetes. Type 1 diabetes is associated with
kidney failure, blindness, nerve damage, life-threatening
cardiovascular disease and limb amputations. Current treatment
options include multiple daily injections of insulin. For further
information: http://www.lctglobal.com/. CONTACT: Dr. Paul Tan Chief
Executive Officer Mob: 021 608 784 (NZ) Tel: +64 9 276 2690 Mr John
Cowan Finance & Administration Manager Tel: +64 9 276 2690
Prof. Bob Elliott Medical Director Mob: +64 27 292 4177 Tel:+64 9
276 2690 Paul Dekkers Investor and Media Relations Tel: +612 9237
2800 DATASOURCE: Living Cell Technologies CONTACT: Dr. Paul Tan,
Chief Executive Officer, Mob: +021-608-784 (NZ), Tel:
+64-9-276-2690, or , Mr. John Cowan, Finance & Administration
Manager, Tel: +64-9-276-2690, or , Prof. Bob Elliott, Medical
Director, Mob: +64-27-292-4177, Tel: +64-9-276-2690, or , all of
Living Cell Technologies; Paul Dekkers, Investor and Media
Relations, Tel: +1-612-9237-2800, or , for Living Cell Technologies
Web Site: http://www.lctglobal.com/
Copyright