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Living Cell Technologies' Advanced DiabeCell(R) Biocapsule Formulation Undergoing Clinical Trials for Treatment of Type I Diabetes

Posted on: Wednesday, 1 August 2007, 09:05 CDT

Living Cell Technologies Limited (ASX: LCT) today announced that the enhanced longevity of its advanced biocapsule formula, currently being tested in a Phase I/IIa clinical trial for type I diabetes, was highlighted in a study published by Journal of BioMedical Materials Research Part A, a leading publication focused on the materials science aspect of drug delivery systems.

Dosing of the first patient in a Phase I/IIa clinical trial was recently completed using the Company's proprietary DiabeCell(R) pig islet cell transplant to treat type I diabetes. The trial is being conducted in six type 1 (insulin-dependent) diabetic patients. Participants in this trial are given the lowest clinically effective dose to demonstrate safety and then dosing is repeated for additional clinical benefit. An initial transplant dose equivalent to 5,000 IEQ (islet equivalents/kg) is administered by injection into the peritoneal cavity, followed by a second transplant six months later. Follow-up monitoring will continue for 12 months. The Company is anticipating that it will receive approval to commence a second clinical trial later this year.

Living Cell's proprietary micro-encapsulation technology coats pancreatic islet cells to prevent their rejection when transplanted into patients. The Company's enhanced, ultra-pure, micro-encapsulation formulation was compared with a baseline formulation that was developed using semi-pure alginates that had been prepared using commercially available manufacturing processes. Living Cell's microcapsules retained their physical integrity for at least 215 days, the study endpoint, whereas the baseline formulation was stable for less than 60 days. Both the LCT and baseline biocapsules were tested without live cells inside.

Following in vivo implantation in animals for varying periods of time up to 215 days, the quality of the surface of the microcapsules was assessed using several analytical techniques that included Fourier-transform infrared spectroscopy and scanning electron microscopy. Living Cell's explanted capsules revealed a smoother, more chemically intact surface.

"This study confirms that we have achieved an ideal alginate biocapsule that, combined with our method of preparing pig islet cells, results in a biocompatible product more likely to be durable and functional in the body over long periods of time, potentially enabling us to avoid the use of immunosuppressant drugs and their side effects," commented Dr. Chris Thanos, lead-author of the study.

The enhanced composition of the fully characterized alginate-polyornithine micro-capsules showed advantages in physical strength and longevity, indicating that small changes in encapsulation methodologies and materials selection can dramatically impact the stability and longevity of alginate microcapsules and their cell contents.

Alginate, in its purest form, can be an extremely biocompatible barrier because it is resistant to attack from the host immune system, while it simultaneously allows diffusion of secreted proteins across the membrane into the body. It has been widely used to introduce cell-based therapeutics into the body, but success has varied greatly due to methods of manufacture.

Professor Riccardo Calafiore of the University of the Perugia in Italy, and pioneer of Living Cell's alginate, stated, "We have found a way to purify alginate for making smooth, long surviving capsules without surface pitting, so that inner layers and cells inside are not exposed." Living Cell holds an exclusive license for the use of Perugia alginate.

Living Cell has previously reported survival of cells and capsules 10 years after implant in a prototype product, indicating that capsules may enable significant longevity beyond the scope of this study, which may eventually reduce the frequency of implantations required by the patient.

Journal Article Reference:

Thanos CG, Calafiore R, Basta G, Bintz BE, Bell WJ, Hudak J, Vasconcellos, A, Schneider P, Skinner SJM, Geaney M, Tan P, Elliott RB, Tatnell, M, Escobar L, Qian H, Mathiowitz E and Emerich DF. 'Formulating the alginate-polyornithine biocapsule for prolonged stability. Evaluation of composition and manufacturing technique.' J BioMedical Materials Research Part A, 2007, 83A:1, October 2007 (Wiley Interscience)

LCT's US ADR program

LCT's ADR program is now effective (OTC: LVCLY, CUSIP Number: 53838R107) and the Bank of New York is in the process of arranging market makers for the company. In the meantime more information about investing in the LCT ADR program can be obtained directly from Violet Pagan Vice President Depositary Receipts at the Bank of New York, who can be contacted by phone on: (212) 815 2276 , or by email : vpagan@bankofny.com . Violet is happy to assist brokers and investors with any queries they may have.

About Living Cell Technologies: www.lctglobal.com

Living Cell is developing live cell therapy 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.

LCT disclaimer

This document contains certain forward-looking statements, relating to LCT's business, which can be identified by the use of forward-looking terminology, 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. In particular, management's expectations regarding the approval and commercialization of product candidates could be affected by, among other things, unexpected clinical trial results; 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.

 Further information:  www.lctglobal.com Images available by contacting Email Contact or calling Paris Brooke on +61 3 9886 0247  Dr. Paul Tan CEO Tel: +61 402 716 984  Investor / public relations Mark Jones Global Consulting Group Tel: +1 646 284 9414  

SOURCE: Living Cell Technologies

Source: MARKET WIRE

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