Asia PR News

MELBOURNE, Jan. 30 /Medianet International - AsiaNet/ –

Living Cell Technologies Ltd (ASX:LCT) today announced its DiabeCell® 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® 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® 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® 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® 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. Prof 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

SOURCE: Living Cell Technologies Ltd