Medical Director of Living Cell Technologies, Professor Bob Elliott, advised that two patients have been implanted with their first dose of DiabeCell® and are due for a second dose six months later.
The first patient was injected with his first dose in June 2007, without adverse effects. Control of blood glucose levels has been maintained, while his daily insulin requirement was gradually reduced by about 40% over the past four months.
The second recipient was implanted with her first dose of DiabeCell® in September 2007, without adverse effects and control of blood glucose has been maintained with progressive reduction of daily insulin requirements. At one month following the implant, this patient has been weaned off insulin altogether.
"These early stage results have exceeded our expectations, with one patient no longer dependant on insulin therapy following the smallest dose of DiabeCell®," said Professor Elliot.
Living Cell Technologies Chief Executive Officer Dr. Paul Tan commented: "This promising result increases the prospects of DiabeCell® as an effective commercial treatment for diabetes."
The object of the phase I/IIa trial is to determine whether a small dose of live micro-encapsulated pig islets injected into the abdominal cavity of type 1 diabetic patients is safe and can produce enough insulin to have a measurable effect on improving the control of blood glucose levels.
In the trial at the Sklifasovsky Institute in Moscow, each of six patients is to receive two transplants of the smallest dose, 5,000 islet equivalents (IEQs), which is equivalent to one third of the maximum dose (15,000 IEQs) planned for testing in the Company's proposed New Zealand clinical trial.
The Company cautioned that the data is very preliminary and should be interpreted in the context of complete data that will be accrued from the remainder of the trial.
Further information on the Company's current clinical trial is available at www.lctglobal.com.
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.
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 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 October 22, 2007 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.
Contact: Contacts:
Richard Justice Chief Financial Officer Tel: +64-9-276-2690 (x. 739) Mobile: +64-21-223-4741
Dr. Paul Tan Chief Executive Officer Tel: +64-9-270-7941 Mobile: +61-402-716-984
Rachel Levine Investor and Media Relations Tel: +646-284-9439 Email: rlevine@hfgcg.com
Source: Living Cell Technologies
