JoeC
01-29-2007, 11:13 PM
LCT to Start Clinical Trial of Type 1 Diabetes Treatment
MELBOURNE, Australia, Jan. 29 /PRNewswire-FirstCall/ -- Living Cell
Technologies Ltd (ASX: LCT) today announced its DiabeCell(R) Type 1
diabetes treatment has been approved for a Phase I/IIA clinical trial in
Russia designed according to FDA guidelines and monitored by a Boston-based
Contract Research Organisation.
DiabeCell(R) is a porcine pancreatic cell product for the treatment of
insulin-dependent diabetes. The natural neo-natal pig islet cells are
encased in capsules that allow insulin to be released but prevents the
patient's immune system from attacking the cells. The islets are simply
injected into the body and produce insulin as needed in response to the
levels of glucose in the blood.
The trial may enable an expedited route to commercialisation within the
region. Initial response to treatment will be evident within six months.
The trial will use cells from fully-screened and biocertified pigs, bred
according to US FDA (Food and Drug Administration) guidelines.
"Along with international biopharmaceutical firms, LCT is taking
advantage of the growing interest and availability of funds for
biotechnology in Russia," said LCT CEO, Dr Paul Tan. "The pharmaceutical
industry has noted Russia's centralised medical infrastructure and
efficient recruitment of patients into clinical trials. The rapid
regulatory process in Russia and the accepted use of animal cells in
treating human disease may shorten the time to market."
"The approval of the DiabeCell(R) human clinical trial is a significant
milestone for this new treatment option for type 1 diabetes," said Dr John
Court, expert on adolescent diabetes and scientific advisor to LCT. "This
is the only human clinical trial of this kind approved anywhere in the
world and recognises LCT's thorough pre-clinical testing of the product in
animal models showing no adverse safety effects and a significant reduction
in insulin requirements."
"DiabeCell(R) offers considerable advantages over other available
treatments as there is no need for immuno-suppressive drugs and the supply
of cells from LCT's natural biocertified pig herds are readily available,
unlike human organ donors. Type 1 diabetes urgently needs a new treatment
that is better than current regimens of insulin treatment," Dr Court said.
"As a Company at the forefront of the xeno-cell therapy industry -- and
clearly ahead of the competition, LCT's intention is to conduct more than
one Phase I/IIA Clinical Trial," said Dr Tan.
In Russia, DiabeCell(R) would be trialled in six Type 1
(insulin-dependent) diabetics in two stages. It is anticipated that the
trial would start in the second quarter of 2007, with potential patients
already identified. The 12-month phase I/IIA trial will be led by Professor
Skaletsky of the ANO Institute of Biomedical Research in Moscow. Professor
Skaletsky and the Institute have extensive experience in organ
transplantation and xenotransplantation, having performed over 1,500 animal
cell transplants in patients.
Boston-based GenyResearch Group will act as the project manager to
ensure all elements of the trial adhere to international and FDA standards.
They will oversee the protocols and be responsible for all data analysis
and management, and provide a trial report that may be submitted along with
data from international studies for regulatory approval in any
jurisdiction.
Further information:
Dr Paul Tan
CEO
Cell: +64 21 608 784
MELBOURNE, Australia, Jan. 29 /PRNewswire-FirstCall/ -- Living Cell
Technologies Ltd (ASX: LCT) today announced its DiabeCell(R) Type 1
diabetes treatment has been approved for a Phase I/IIA clinical trial in
Russia designed according to FDA guidelines and monitored by a Boston-based
Contract Research Organisation.
DiabeCell(R) is a porcine pancreatic cell product for the treatment of
insulin-dependent diabetes. The natural neo-natal pig islet cells are
encased in capsules that allow insulin to be released but prevents the
patient's immune system from attacking the cells. The islets are simply
injected into the body and produce insulin as needed in response to the
levels of glucose in the blood.
The trial may enable an expedited route to commercialisation within the
region. Initial response to treatment will be evident within six months.
The trial will use cells from fully-screened and biocertified pigs, bred
according to US FDA (Food and Drug Administration) guidelines.
"Along with international biopharmaceutical firms, LCT is taking
advantage of the growing interest and availability of funds for
biotechnology in Russia," said LCT CEO, Dr Paul Tan. "The pharmaceutical
industry has noted Russia's centralised medical infrastructure and
efficient recruitment of patients into clinical trials. The rapid
regulatory process in Russia and the accepted use of animal cells in
treating human disease may shorten the time to market."
"The approval of the DiabeCell(R) human clinical trial is a significant
milestone for this new treatment option for type 1 diabetes," said Dr John
Court, expert on adolescent diabetes and scientific advisor to LCT. "This
is the only human clinical trial of this kind approved anywhere in the
world and recognises LCT's thorough pre-clinical testing of the product in
animal models showing no adverse safety effects and a significant reduction
in insulin requirements."
"DiabeCell(R) offers considerable advantages over other available
treatments as there is no need for immuno-suppressive drugs and the supply
of cells from LCT's natural biocertified pig herds are readily available,
unlike human organ donors. Type 1 diabetes urgently needs a new treatment
that is better than current regimens of insulin treatment," Dr Court said.
"As a Company at the forefront of the xeno-cell therapy industry -- and
clearly ahead of the competition, LCT's intention is to conduct more than
one Phase I/IIA Clinical Trial," said Dr Tan.
In Russia, DiabeCell(R) would be trialled in six Type 1
(insulin-dependent) diabetics in two stages. It is anticipated that the
trial would start in the second quarter of 2007, with potential patients
already identified. The 12-month phase I/IIA trial will be led by Professor
Skaletsky of the ANO Institute of Biomedical Research in Moscow. Professor
Skaletsky and the Institute have extensive experience in organ
transplantation and xenotransplantation, having performed over 1,500 animal
cell transplants in patients.
Boston-based GenyResearch Group will act as the project manager to
ensure all elements of the trial adhere to international and FDA standards.
They will oversee the protocols and be responsible for all data analysis
and management, and provide a trial report that may be submitted along with
data from international studies for regulatory approval in any
jurisdiction.
Further information:
Dr Paul Tan
CEO
Cell: +64 21 608 784