Living Cell Technologies Announces First Diabetes Patient Successfully Dosed in Phase I/IIa DiabeCell(R) Trial
Proprietary Pig Cell Implant Technology
MELBOURNE, AUSTRALIA--(Marketwire - June 14, 2007) - Living Cell Technologies Ltd. (ASX: LCT), a leading developer of live cell therapy products to treat life
threatening human diseases, announced today that it has successfully dosed
its first patient in a Phase I/IIa clinical trial using its proprietary
DiabeCell® pig islet cell transplant to treat type I diabetes.
The DiabeCell® clinical trial is being conducted in six type 1
(insulin-dependent) diabetics. Recipients in this first trial are given the
lowest clinically effective dose to demonstrate safety and then dosing is
repeated for additional clinical benefit. The patients receive an initial
transplant dose equivalent to 5,000 IEQ (islet equivalents/kg) administered
by injection into the peritoneal cavity, followed by a second transplant
six months later. Follow up monitoring will continue for 12 months.
The primary efficacy endpoint for the trial is reduction in hemoglobin A1C
(HbA1C) levels over the 12-month post-transplant period compared with
baseline (week-1). Secondary efficacy endpoints include glucose lability,
reductions in hypoglycemia and nocturnal hypoglycemia, reductions in the
average daily insulin dose of > 20%, changes in endogenous insulin
secretion, and quality-of-life changes.
DiabeCell® is a pig pancreatic islet cell product that secretes insulin
in response to the patient's blood glucose levels. People with type I
diabetes are not able to produce their own insulin because their pancreas
cells are not functioning. DiabeCell® has been uniquely developed so
that when the recipient diabetic is injected, it is not destroyed by the
recipient's immune system. The natural cells are coated in an alginate gel
that forms a tiny capsule around the cells and prevents the patient's
immune system from destroying the transplant.
Professor Bob Elliott, LCT's Medical Director, commented, "DiabeCell® has
the potential to provide greater independence from insulin for diabetics,
as well as better control of dangerous blood glucose levels and long-term
secondary complications, as well as the benefits from not requiring
immunosuppressive treatment. If the trial is successful, a major stride in
developing a better treatment for diabetes will have been accomplished."
The 12-month Phase I/IIa trial is being conducted at the Sklifosovsky
Clinical and Research Institute in Moscow, which has extensive experience
in organ transplantation and xenotransplantation. Boston-based contract
research organization (CRO) GenyResearch Group is managing the project to
ensure all elements of the trial adhere to international regulatory
standards. LCT's Russian partner is funding the trial, including
GenyResearch Group's services. LCT is supplying the cells and will retain
all intellectual property and commercial rights to the product.
Once the initial Phase I/IIa trial is completed to ensure safety, a second
12-month study addressing the level of its effect in diabetics will be
conducted.
The Company owns and operates a bio-certified pig herd for supply of cells,
a GMP manufacturing unit to prepare the treatment and a specialized
monitoring laboratory for assessing transplant recipients. The company
also holds a strong patent portfolio in markets where DiabeCell® will be
commercialized.
Dr Paul Tan, LCT CEO, stated, "The movement of DiabeCell® into the clinic
is a significant milestone for LCT. We have a commercial strategy in place
and look forward to progressing discussions with various regulatory
authorities and partners."
Scientific papers relating to DiabeCell® are available for download on
the LCT website at www.lctglobal.com/scientificarticles.php.
About Living Cell Technologies: www.lctglobal.com
Living Cell Technologies Ltd (ASX: LCT) develops live cell therapy products
to treat life threatening human diseases. The ASX listed, vertically
integrated company focuses on developing treatments where healthy living
cells are injected into patients to replace or repair damaged tissue,
without requiring the use of toxic drugs to prevent rejection. LCT owns a
biocertified pig herd for the supply of medical-grade cells and is
developing products to treat diabetes and neurological disorders.
Contact Information: Contact information: Images available upon request -
In New Zealand:
Paul Tan
CEO
LCT
Tel: +649 270 7943
Mobile: + 64 21 608 784
In the US:
Mark Jones
Global Consulting Group
Tel: +1 646 284 9414