Insulin Delivery from Implants
Living Cell Technologies Confirms Insulin Delivery from Implants in Diabetes Clinical Trial
June 25, 2008 – Melbourne, Australia and Auckland, New Zealand - Living Cell Technologies Limited (ASX:LCT; OTC: LVCLY) today reported that patients in the DiabeCell® phase I/IIa diabetes clinical trial had porcine insulin in their blood samples providing additional scientific confirmation that implants of DiabeCell® actively produce insulin and directly contribute to clinical benefit.
Professor Bob Elliott, LCT Medical Director said, “The early clinical response in the first two patients showed that following DiabeCell® treatment they were able to control their diabetes with reduced insulin dose. By detecting porcine insulin in blood samples, we have demonstrated with certainty that the reduced insulin requirement is due to the implanted cells.”
“Porcine insulin was present in the circulation of the first patient at 11 months follow up and in the second patient six months after receiving the implant. In the second patient this was detected after she stopped insulin injections, clearly demonstrating the effect of the implants,” continued Professor Elliott.
Dr Paul Tan, LCT Chief Executive Officer said, “This recent information is consistent with LCT’s published research which demonstrated presence of porcine insulin in a patient 10 years after a similar implant. This has now been validated again after 11 months without use of immunosuppressive drugs in the current trial and at the lowest dose of DiabeCell®. The long term functioning of the encapsulated cells is important and we expect LCT’s current encapsulation technology to keep the cells alive and functioning long term.”
“The preliminary data from this world-first diabetes clinical trial of encapsulated porcine insulin-producing cells gives us increasing confidence as we advance DiabeCell® to larger scale trials with higher doses,” continued Dr Tan. LCT announced earlier this month that it would be expanding the Russian trial.
This preliminary data from the first two patients
will be followed by results from the other patients in the
trial. All five patients who have received transplants are
participating in the follow-up program. All remain well and
without complication. The first two patients have received
their second implant while the other three are to be
scheduled for their second implants.
Professor Bob Elliott is travelling to Russia in July to review all patients with their personal physicians and to collate clinical data. LCT expects to provide a complete trial update in late July.
DiabeCell®, encapsulated porcine insulin producing cells, is the Company’s lead product. It is currently undergoing Phase I//IIa clinical trials for insulin dependent Type 1 diabetes.
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 developing”,“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 June 25 , 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.