LCT Expands Diabetes Clinical Trial
LCT Expands Diabetes Clinical Trial
June 5, 2008 – Melbourne, Australia and Auckland, New Zealand - Living Cell Technologies Limited (ASX:LCT; OTC: LVCLY) today announced that the positive preliminary data from its first clinical trial of DiabeCell® for insulin dependent Type 1 diabetes has encouraged the Company to expand the trial and proceed with testing higher doses.
In LCT’s first Phase I/IIa trial of DiabeCell®, its lead product of encapsulated porcine insulin producing cells, five patients were implanted with the lowest dose. As reported in the Company’s clinical update on 31 March 2008, there were no significant adverse effects and a clinical effect was demonstrated with reduction in daily insulin requirement for up to six months follow up with satisfactory control of blood glucose.
Professor Bob Elliott, LCT Medical Director said: “The clinical effects observed with the lowest dose and the uncomplicated safety profile to date have encouraged our clinical experts in Moscow to implant higher doses with the expectation of greater clinical benefit.”
LCT’s Chief Executive Officer, Dr Paul Tan said: ‘The scientific and ethics approvals allowed the trial protocol to be revised and continued with the total number of patients increased from 6 to 10 at this stage. In subsequent implants, the dose of DiabeCell® will move up from 5,000 islet equivalents per kilogram body weight (IEQ/kg) to 10,000 IEQ/kg.’
“This revision of the clinical protocol in Moscow in effect expedites our clinical program for DiabeCell®,” said Dr Paul Tan.
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