(MENAFN - ProactiveInvestors - Australia) Living Cell Technologies (ASX: LCT; OTCQX: LVCLY) has begun patient recruitment in Argentina for a phase IIb trial of DIABECELL to treat type-1 diabetes.
Treatment with DIABECELL involves transplanting pig pancreatic islet cells into a patient's abdomen to boost insulin production and help regulate blood glucose levels.
Living Cell Technologies remains on track to meet its goal of completing clinical trials of the treatment by 2015 and having a product commercially available by 2016.
Importantly, DIABECELL is the first islet transplant treatment that does not require ongoing administration of debilitating immunosuppression drugs.
The Argentinean trial is designed to demonstrate the clinical benefits of DIABECELL in unstable type-1 diabetes.
Twenty patients will receive two implants of 10,000 islet equivalents per kilogram of body weight, with the second implant occurring 12 weeks after the first.
This dose was shown to be most clinically effective in reducing HbA1c, insulin dose and unaware hypoglycaemic events in the recently announced interim analysis of the phase I/IIa trial in Argentina.
Greater benefit was witnessed in the patient group receiving the higher dose of DIABECELL.
DIABECELL is owned by joint venture company Diatranz Otsuka, in which Living Cell Technologies and Otsuka Pharmaceutical Factory both have a 50% interest.
Goals for 2012/13
Living Cell Technologies aims to begin a phase III DIABECELL trial in type-1 diabetes in Argentina, New Zealand and Germany.
The company is also working to complete all implants during 2013.
In addition, Living Cell Technologies will finalise its commercialisation plan for DIABECELL and look to secure additional partnerships for ongoing funding of current products and to strengthen its product pipeline with new products.