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Living Cell Technologies’ Accepts Revised Conditions for Diabetes Clinical Trial in New Zealand
19 June 2009: Sydney, Australia, Auckland, New Zealand– Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced the Company has accepted a preliminary decision from the New Zealand Minister of Health, the Honourable Tony Ryall, to issue a new conditional authorization for its New Zealand Phase I/IIa clinical trial of DIABECELL® for insulin dependent diabetes.
The Minister’s letter states that “the proposed condition that would require (LCT) to amend the inclusion criteria of (LCT’s) study to limit participation in the study to patients with brittle diabetes who suffer from significant metabolic instability is essential to ensure that the study complies with international guidelines, which require that participants obtain maximum benefit possible from their participation in the study”.
The other proposed changes to the existing conditions are matters that LCT has agreed are appropriate during the peer review process, or are changes of a procedural, rather than a substantive nature …."
The Company said that the clinical protocol for the New Zealand diabetes trial has already been amended according to the proposed new conditions from the Minister. LCT is pleased to have worked with the Ministry of Health to finalise the protocols for the clinical trial of DIABECELL®.
About Living Cell Technologies: www.lctglobal.com
Living Cell Technologies (LCT) is developing cell-based products to treat life threatening human diseases. The Company owns a biocertified pig herd that it uses as a source of cells for treating diabetes and neurological disorders. For patients with type 1 diabetes, the Company transplants microencapsulated islet cells so that near-normal blood glucose levels may be achieved without the need for administration of insulin or at significantly reduced levels. The company entered clinical trials for its diabetes product in 2007. For Parkinson’s disease, Huntington’s disease and other neurological disorders, the company is developing microencapsulated choroid plexus cells that deliver beneficial proteins and neurotrophic factors to the brain. LCT’s technology enables healthy living cells to be injected into patients to replace or repair damaged tissue without requiring the use of immunosuppressive drugs to prevent rejection. LCT also offers medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.
This document contains certain forward-looking statements, relating to LCT’s business, which can be identified by the use of forward-looking terminology such as “promising,” “plans,” “anticipated,” “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to,” “potential,” “seeking to,” “goal,” “could provide,” “intends,” “is being developed,” “could be,” “on track,” or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other health authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialisation of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. LCT is providing this information as of April 2009 and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
Living Cell Technologies Ltd
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