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Xenotransplantation Should Be Allowed To Develop In New Zealand, Bioethics Council

June 15, 2017

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.

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
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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
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
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