Living Cell Technologies Receives Grant from Juvenile Diabetes Research Foundation International for DIABECELL® NZ Clinical ...
April 26 2010 - 7:17PM
Business Wire
Living Cell Technologies Limited (ASX:LCT)
(OTCQX:LVCLY), a global company pioneering the development of a
cell implant to treat diabetes, has received a grant of US$500,000
for its on-going Phase II clinical trial of DIABECELL® in New
Zealand from the Juvenile Diabetes Research Foundation
International (JDRF), a world leader in setting the agenda for
diabetes research and the largest charitable funder and advocate
for research in type 1 diabetes.
The first four patients have already received implants and early
observations show clinical benefit without remarkable adverse
events to date. The Data Safety Monitoring Board has approved
proceeding with implants of a higher dose for the next four
patients. The JDRF grant will contribute to the second portion of
the Phase II trial, which will test the safety and efficacy of
DIABECELL® given in higher amounts in patients with type 1
diabetes.
“The initial results from the first phase of the trial showed us
a significant feature of LCT’s product in its ability to protect
the cells from immune rejection without the use of
immunosuppressive anti-rejection drugs,” said Dr Julia Greenstein,
Ph.D., Director of Beta Cell Therapies at JDRF. “Encapsulation for
immuno-protection is one of JDRF’s research priorities, and the
success of this trial could have an important impact on this field
of research and the development of a commercially-viable cell
replacement therapy for people with type 1 diabetes.”
Professor Bob Elliott, medical director of LCT, said, “At this
early stage, we have seen the abolition of unaware hypoglycaemia in
the first patient. This diabetes complication occurs in up to 17
percent of long term type 1 diabetic people, and is responsible for
up to 8 percent of all deaths in type 1 diabetes. The grant from
the JDRF is most welcome as we share the same concerns for diabetes
patients who endure life threatening episodes of low blood glucose
without warning symptoms.”
Dr Paul Tan, Chief Executive Officer for LCT, said, “We are
delighted that the JDRF, the world’s largest charitable funder and
advocate of diabetes science worldwide, is supporting the progress
we are making to advance DIABECELL® towards normalising the lives
of people with unstable diabetes.”
The collaboration with JDRF and LCT for the Phase II trial of
DIABECELL® is part of JDRF’s innovative Industry and Discovery and
Development Partnership program. Through the program, JDRF partners
with pharmaceutical, biotech, and medical device businesses that
seek to develop drugs, treatments, technologies, and other
therapeutics leading to a cure, reversal, or prevention of type 1
diabetes and its complications. To date, JDRF has made 27 industry
grant awards to support a variety of strategic type 1 diabetes
research projects since the IDDP program was established in
2004.
Type 1 diabetes is an autoimmune disease in which a person’s
pancreas stops producing insulin, a hormone that enables people to
get energy from food. Type 1 diabetes strikes children and adults
suddenly, and lasts a lifetime. People with type 1 diabetes must
take multiple injections of insulin daily or continuous infusion of
insulin through a pump to survive. Intensive insulin treatment to
normalize blood glucose and prevent future eye, kidney, nervous
system and cardiovascular complications can sometimes result in
hypoglycaemic unawareness, a loss of the normal stress response to
low blood glucose levels. People with type 1 diabetes and
hypoglycaemic unawareness feel no warning symptoms when their blood
glucose levels drop to low levels that can impair consciousness and
lead to accidents and coma. (www.diabetesnet.com and
www.diabetesselfmanagement.com)
DIABECELL® is LCT’s treatment designed to normalise the lives of
people with insulin-dependent diabetes. DIABECELL®comprises
encapsulated porcine insulin-producing cells (islets) 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. LCT's breakthrough proprietary
encapsulation technology means that patients receiving DIABECELL®
treatment do not require immunosuppressant drugs after
implantation.
About Living Cell Technologies - www.lctglobal.com
Living Cell Technologies (LCT) is developing cell-based products
to treat life threatening human diseases. LCT’s technology enables
healthy living cells to be injected into patients to replace or
repair damaged tissue without requiring the use of
immunosuppressant 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.
The Company owns a bio-certified pig herd that is a source of
cells for treating diabetes and neurological disorders. For
patients with type 1 diabetes, the Company implants
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. 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.
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authorities’ requirements regarding any one or more product
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candidates will be approved by any health authorities for sale in
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In particular, management’s expectations regarding the approval and
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among other things, unexpected clinical trial results, including
additional analysis of existing clinical data, and new clinical
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For further information: www.lctglobal.com
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