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Cell Therapy Supported Through Bioethics Recommendation
14 December, 2005 – Auckland,
New Zealand and Melbourne, Australia: Living Cell Technologies (ASX: LCT)
welcomes the final recommendation by Toi te Taiao: the Bioethics Council, that
xenotransplantation should be allowed to develop in New Zealand.
The Bioethics Council report entitled ‘The Cultural, Spiritual and Ethical
Aspects of Animal-to-Human Transplantation’ presents final recommendations to
the New Zealand Minister for Environment after a year of public consultation and
ethical review.
“The principal recommendation is a further positive step for cell therapy, as it
continues to open the path to market for xeno-based therapies,” said Mr David
Collinson, CEO, Living Cell Technologies Ltd.
LCT also welcomes the Council’s recommendation for the implementation of an
appropriate regulatory and decision-making framework, as well as appropriate
measures to ensure that all xenotransplantation research is conducted under
these guidelines.
“LCT has developed its technology in line with the rigorous xenotransplantation
guidelines administered by the US FDA and we would welcome New Zealand providing
a similar, positive role to guide the development of xeno-based therapies.”
The Bioethics Council was established in 2002 to consider the cultural, ethical
and spiritual issues raised by biotechnology. During the year, the Council has
conducted a dialogue on animal to human transplantations, through open
submissions, an online forum and a series of dialogue meetings. The report
released today is a reflection of these discussions.
The Bioethics council recommendation follows LCT’s meeting with the US Food and
Drug Administration (FDA) to discuss the pre-clinical data, research data,
manufacturing and clinical trial strategy for its first cell therapy product,
NeurotrophinCell.
“The meeting with the FDA was very positive, we have a clearly defined path to
move forward and have no doubts on our ability to take our products to the
clinic.”
Details of the meeting will be disclosed upon receipt of the meeting minutes.
“The legislative and regulatory environment is opening up to the potential of
cell therapy, as a viable and accessible treatment for today,” said Mr Collinson.
Contacts:
Images and background information available upon request.
Peter De Luca
Media
+61 3 9813 5501
+61 401 002 008
David Collinson
CEO
+64 21 921 130
0402 716 984
Dr Paul Tan
Managing Director (NZ)
+64 9 270 7941
Paris Brooke
General Manager (AUS)
+61 3 9813 5501
+61 407 715 574
Further information / background brief:
What is xenotransplantation?
In medicine, xenotransplantation is the use of living non-human animal
cells, tissues or organs to treat humans. Transplantation of tissues, such as
bone marrow, or clusters of specialised cells, such as pancreatic islet cells
are known as cell therapies.
About Living Cell Technologies:
www.lctglobal.com
Living Cell Technologies Ltd (ASX: LCT) develop live cell therapy products
to treat life threatening human diseases. The ASX listed, vertically integrated
company operates globally through offices in Australia, New Zealand and the
United States.
LCT 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. The company’s product portfolio focuses on
treatments for people with Huntington’s disease, insulin-dependent diabetes and
haemophilia.
About Toi te Taiao: The Bioethics Council:
www.bioethics.org.nz
The Bioethics Council was established in 2002 to consider the cultural, ethical
and spiritual issues raised by biotechnology. The focus of the consultation was
on animal to human transplantation, looking at what the process involves and the
related cultural, ethical and spiritual concerns.
In 2002, the Government passed an amendment (Part 7A) to the Medicine Act 1981.
Part 7A allows xenotransplantation trials to be considered and approved by the
Minister of Health, but requires strict criteria to be met before an approval is
given. This relevant section of the Medicine Act 1981 is due to expire at the
end of 2006. One of the key tasks of the Council was to consult and engage with
Maori, as part of its commitment to the Treaty of Waitangi.
During the year, the Council has conducted a dialogue on xenotransplantation,
through open submissions, an online forum and a series of dialogue meetings. The
report released today is a reflection of these discussions.
Living Cell Technologies Ltd
Pacific Tower
Suite 2.11, 737 Burwood Road
Hawthorn VIC 3122
Tel: +61 3 9813 5501
Fax: +61 3 9813 5502
Mob: 0401 002 008
Email: pdeluca@lctglobal.com
Web: www.lctglobal.com
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