LCT's DIABECELL® trial extension approved
17 May 2012: Sydney, Australia & Auckland, New Zealand - Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) has received approval from the New Zealand Minister of Health to trial a higher dose of its DIABECELL® product.
- Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) has received approval from the New Zealand Minister of Health to trial a higher dose of its DIABECELL® product.
A Phase 2 clinical trial of DIABECELL for treating unstable type 1 diabetes has been underway in New Zealand for two years. Establishing optimal dosage is a central aspect of the trial. This permission to proceed with the highest dose in two further patients will allow firm conclusions to be drawn about the optimum single dose. The New Zealand data combined with the results from a similar trial being conducted in Argentina, which uses two sequential doses, will ensure the optimum design of a pivotal trial. The company expects to start this in Q1 2013.
Professor Bob Elliott, LCT's Medical Director, said, "This approval, with additional ethical approval, allows us to build a more complete picture of the best procedure. Our preliminary report presented in Prague last year, which suggested more benefit from some doses than others, can be crystallised."