Living Cell Technologies and US-Based Barbara Davis Center to Collaborate on Diabetes Clinical Trial Program
MELBOURNE, AUSTRALIA and AUCKLAND, NEW ZEALAND - Living Cell Technologies Limited (ASX: LCT) (PINKSHEETS: LVCLY) today announced that the Company has signed a term sheet with the Barbara Davis Center for Childhood Diabetes (BDC) to establish a diabetes clinical trial program in Denver, Colorado.
BDC and LCT will collaboratively pursue regulatory approval and then conduct a U.S. clinical trial in Type 1 diabetes with DiabeCell®, LCT's encapsulated porcine insulin producing cells. The proposed U.S. trial is planned to commence in 2009 and will be planned utilizing the clinical protocols and results from LCT's trials in Russia and New Zealand.
Professor George Eisenbarth, Professor of Medicine and Pediatrics at the BDC said: "The lack of adverse effects and the encouraging early clinical results from LCT's first DiabeCell® trial have prompted us to do a trial in Denver."
Dr. Paul Tan, Chief Executive Officer of LCT added: "We are pleased to have the extensive clinical trial capability of experts from one of the most established diabetes centers in the U.S. to help us get DiabeCell® to people with diabetes."
BDC is the largest diabetes and endocrine care program in Colorado. The Center is managed as a distinct administrative unit of the University of Colorado Denver School of Medicine.
BDC provides unique facilities and resources for clinicians, clinical researchers and basic biomedical scientists working to help patients with Type 1 diabetes. The Center provides state-of-the-art clinical diabetes care to 80% of children in Colorado and many adults within the Rocky Mountain Region, as well as receiving national and international referrals.
About Living Cell Technologies: www.lctglobal.com
Living Cell 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 the treatment of Huntington's disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells that deliver beneficial proteins and neurotrophic factors to the brain. Living Cell'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. Living Cell 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 commercialization 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 materialize, 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 February 27, 2008, 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.
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