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ASX Announcement – 16 February, 2006, Melbourne, Australia: Living Cell Technologies Limited (ASX:LCT) today reported it has held positive meetings with the US Food and Drug Administration (FDA) and New Zealand’s MedSafe, regarding its NeurotrophinCell and DiabeCell products. “The meetings have provided strong reassurance that xeno-based cell therapies have a clear and defined pathway to market,” said LCT CEO, Mr David Collinson. NeurotrophinCell: Representatives from LCT attended the pre-IND meeting with members of the National Institutes of Health (NIH) and reviewers from the Centre for Biologics Evaluation and Research (CBER), the group within the FDA responsible for the evaluation of biologics, including cell and gene therapies. “This is a very important step in completing the roadmap to satisfy regulatory requirements and moves the Company one step closer in its pursuit of an IND (Investigational New Drug) application for its cell therapy treatment for Huntington’s disease,” said Mr Collinson. The meeting was based upon the submission of a pre-IND dossier for LCT’s Neurotrophin Cell program. The FDA demonstrated their willingness to provide guidance and feedback throughout the process by providing a written response containing draft comments on LCT's pre-IND Meeting Information Package and Neurotrophin Cell development program prior to the meeting. This document enabled an efficient and productive meeting, indicating that LCT’s product development strategy is on the right track. LCT representatives took the opportunity to clarify the FDA’s comments on the specialised medical-grade pig herd, the manufacturing of cell products, the pre-clinical data and clinical trial design and were pleased to see no objections with the program as presented in LCT’s Pre-IND package. The FDA also extended the courtesy to LCT of ongoing involvement in the preparation of the IND. LCT is pioneering new products in the xenotransplanation field and is pleased that the FDA has invited LCT to communicate directly with the FDA’s various sections and experts prior to submitting the original IND application. Such involvement is indicative of the support demonstrated by the FDA and LCT will continue to engage the Agency on a regular basis to progress NeurotrophinCell to clinical trials. “We are grateful to the CBER team for their constructive comments and assistance in defining the most appropriate strategy for the NeurotrophinCell product, and we look forward to further positive interaction with the FDA and the NIH as NeurotrophinCell progresses towards the clinic.” LCT’s first targeted application of NtCell is Huntington’s disease and the company is currently completing toxicity studies and characterising shipping and QA/QC procedures. Targeting a continuation of DiabeCell phase 1 trial: LCT representatives also met with the New Zealand regulator, MedSafe, in mid February to discuss the resumption of a phase 1 clinical trial for LCT’s diabetes product, DiabeCell. In 1996, a phase 1 study was suspended on the basis of the potential for pig virus transfer (PERV porcine endogenous retroviruses). Considerable recent evidence and monitoring now suggests that the concerns over PERV were unjustified. In discussion with MedSafe, LCT has filed a letter of intent to apply for resumption of the phase I trial, potentially starting as early as 2006. Longevity studies to optimize and document the therapeutic duration of the product are continuing. “LCT’s cell therapies are pioneering development programs and therefore we believe collaboration between LCT and the regulatory authorities is critical in defining the safety and performance criteria for the therapies,” said Mr Collinson. LCT will hold a General Meeting in Sydney at the NSW Trade and Investment Centre on 24 February 2006 at 2.45pm, which will include a clinical program update.
About Living Cell Technologies: www.lctglobal.com Living Cell Technologies Ltd (ASX: LCT) develops 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. Additional Information Brief About NeurotrophinCell NeurotrophinCell (NtCell) is LCT’s injectable live cell product being developed for the treatment of patients with neurodegenerative diseases. NtCell is manufactured by LCT using natural porcine cells that are encased in a bio-polymer capsule developed from seaweed. The cells used are choroid plexus brain cells, which produce spinal cord fluid and a range of neurotrophins or growth factors, for the repair and function of the brain. About DiabeCell DiabeCell is a porcine pancreatic cell product for the treatment of type 1 diabetes. The cells produce insulin and help self-regulate blood glucose levels. The natural pancreatic islet cells are encapsulated in an alginate biocapsule and transplanted into the abdominal cavity, without the use of immunosuppression. About the IND Process An IND (Investigational New Drug) is an application to the US Food and Drug Administration (FDA) seeking approval to commence clinical trials in the US. Clinical trials cannot commence in the US until an IND is approved. The IND must contain information in three broad areas:
· Manufacturing – assessed to ensure that the company can adequately produce and supply consistent batches of the drug. · Animal pharmacology and toxicology – pre-clinical data to enable FDA evaluators to assess if the product is reasonably safe to administer to humans without undue risk. Also included is any previous experience with the drug in humans, eg trials conducted outside the US. · Clinical protocols and Investigator information – assess whether the initial trials will expose subjects to unnecessary risks, suitability of proposed investigators and ethical issues Living Cell Technologies Limited Suite 2.11 / 737 Burwood Rd Hawthorn VIC 3122 ABN: 14 104 028 042
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