22nd August 2011: Sydney, Australia & Auckland, New Zealand. Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) a global company pioneering the development of a cell implant to treat diabetes, has implanted the first two patients taking part in a Phase II DIABECELL® clinical trial in Buenos Aires, Argentina.
This is the third jurisdiction to date where LCT, the world leader in xenotransplantation (animal to human implants), has conducted clinical trials. LCT is the only company in the world in clinical trials using this technology. Up to eight adult patients with Type 1 diabetes, including those with unstable diabetes and severe hypoglycaemia, will each receive two implants of DIABECELL, three months apart.
“The great news is that our earlier clinical trials have validated this treatment and shown it can greatly benefit patients suffering from unstable diabetes who don’t have any awareness when their blood glucose levels are low which puts their life at serious risk,” says LCT medical director and acting CEO Bob Elliott.
“We have a treatment that works. However, during this next stage of our clinical trial we will use fewer insulin producing cells, implanted on two occasions and also utilise a different implantation technique to determine if we can provide patients with even greater benefit. The cells were produced by an improved technique that can also be more readily upscaled.”
Phase II clinical trials are typically used by physicians to determine the most effective dosage of any treatment before moving onto Phase III trials which look at the benefit of that treatment and dosage over a much larger group of patients. Earlier clinical trial results of DIABECELL showed that lower dosages had greater benefit than larger dosages.
“We hope to see the effect of these even lower and repeated doses. We are looking for most effective combination before we enter into our final stages of commercialisation,” says Elliott.
LCT will also employ a new variation of the company’s patented IMMUPEL® cell encapsulation technique. The new process avoids a source of capsule imperfection that may affect function. IMMUPEL is used to encapsulate the porcine insulin producing cells to prevent rejection by the recipient.
The Argentinean trial follows a positive assessment from the New Zealand Data Safety and Monitoring Board of the first twelve patients to receive DIABECELL implants in its Phase II trial in New Zealand, as well as favourable two-year follow up data from its Phase I/IIa clinical trial in Russia. LCT recently announced plans for collaborative development of DIABECELL in Asia following the strategic investments made in LCT by ASK in China and Otsuka in Japan.
DIABECELL is LCT’s treatment designed to normalise the lives of people with insulin-dependent diabetes. DIABECELL comprises encapsulated porcine insulin-producing cells (islets) that are implanted into the abdomen of patients using a simple laparoscopic procedure, and work by self-regulating and efficiently secreting insulin in the patient’s body. LCT's breakthrough proprietary encapsulation technology, IMMUPEL™, means that patients receiving DIABECELL treatment do not require immunosuppression after implantation.
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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 implants its lead product DIABECELL, microencapsulated islet cells, in an effort to address the shortcomings of existing insulin therapy. The Company entered clinical trials for its diabetes product in 2007. For the treatment of Parkinson’s disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells, NTCELL, which delivers beneficial proteins and neurotrophic factors to the brain. LCT’s breakthrough microencapsulation technology, IMMUPEL, 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 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 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.