First Pig Cell Implant for Diabetes in NZ
Living Cell Technologies Limited
Company Announcement:
Living Cell Technologies Reports Successful First
Implant Of DIABECELL® In New Zealand
7 October 2009: Sydney, Australia, Auckland, New Zealand – Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced that DIABECELL® was successfully implanted yesterday in the first patient with type 1 diabetes in Auckland, New Zealand.
DIABECELL®, LCT’s encapsulated porcine cells that produce insulin, was implanted by a laparoscopic procedure into the abdomen of a 47 year old man who has had type 1 diabetes for 20 years.
This is the first of eight DIABECELL® implants to be carried out under LCT’s clinical protocol for New Zealand. The protocol was approved by the Minister of Health in June 2009 following international peer review of LCT’s DIABECELL® clinical programme.
The patient was selected based on the protocol criteria for poor control of blood glucose. Despite meticulous specialist supervision of frequent daily insulin injections, he has continuing frequent episodes of high blood glucose, high glycated hemoglobin levels (HbA1c) and unacceptable swings including low blood glucose levels (hypoglycemia).
The trial is being conducted by Dr John Baker, principal investigator and diabetes specialist based at Middlemore Hospital in Auckland. The protocol requires patients to be monitored for 8 weeks before receiving the implant. The first four patients are to receive 10,000 islet equivalents per kilogram body weight (IEQ) of encapsulated pig islets and the next four patients the higher dose of 15,000 IEQ. All recipients of DIABECELL® implants will be followed up intensively for a year and less frequently thereafter. An independent Data Safety and Monitoring Board will assess progress and provide a report six months after the first implant. Details of the trial are available at www.ClinicalTrials.gov.
Dr Paul Tan, Chief Executive Officer LCT said, “The trial in New Zealand has attracted wide global attention with more than 200 reports in the international media. With positive results from our trial in Russia to date, LCT believes it may be able to deliver even better results for people with diabetes as this trial will be using higher doses.”
DIABECELL® is designed to normalize blood glucose levels in type 1 diabetes sufferers. DIABECELL® 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.
About Living Cell
Technologies: www.lctglobal.com
Living Cell
Technologies (LCT) is developing cell-based products to
treat life threatening human diseases. The Company owns a
biocertified pig herd that it uses as a source of cells for
treating diabetes and neurological disorders. For patients
with Type 1 diabetes, the Company transplants
microencapsulated islet cells so that near-normal blood
glucose levels may be achieved without the need for
administration of insulin or at significantly reduced
levels. The Company entered clinical trials for its
diabetes product in 2007. For the treatment of
Parkinson’s disease and other neurological disorders, the
company transplants microencapsulated choroid plexus cells
that deliver beneficial proteins and neurotrophic factors to
the brain. LCT’s technology enables healthy living cells
to be injected into patients to replace or repair damaged
tissue without requiring the use of immunosuppressive drugs
to prevent rejection. LCT also offers medical-grade
porcine-derived products for the repair and replacement of
damaged tissues, as well as for research and other
purposes.
LCT Disclaimer
This
document contains certain forward-looking statements,
relating to LCT’s business, which can be identified by
the use of forward-looking terminology such as
“promising,” “plans,”“anticipated,” “will”,
“project”, “believe”, “forecast”,
“expected”, “estimated”, “targeting”,
“aiming”, “set to,” “potential,” “seeking
to,” “goal,” “could provide,” “intends,” “is
being developed,” “could be,” “on track,” or
similar expressions, or by express or implied discussions
regarding potential filings or marketing approvals, or
potential future sales of product candidates. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual
results to be materially different from any future results,
performance or achievements expressed or implied by such
statements. There can be no assurance that any existing or
future regulatory filings will satisfy the FDA’s and other
health authorities’ requirements regarding any one or more
product candidates nor can there be any assurance that such
product candidates will be approved by any health
authorities for sale in any market or that they will reach
any particular level of sales. In particular, management’s
expectations regarding the approval and commercialization of
the product candidates could be affected by, among other
things, unexpected clinical trial results, including
additional analysis of existing clinical data, and new
clinical data; unexpected regulatory actions or delays, or
government regulation generally; our ability to obtain or
maintain patent or other proprietary intellectual property
protection; competition in general; government, industry,
and general public pricing pressures; and additional factors
that involve significant risks and uncertainties about our
products, product candidates, financial results and business
prospects. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from
those described herein as anticipated, believed, estimated
or expected. LCT is providing this information and does not
assume any obligation to update any forward-looking
statements contained in this document as a result of new
information, future events or developments or
otherwise.
ENDS