Strong interim result in Phase I/IIa DIABECELL® trial
Living Cell Technologies
Strong interim results in Argentinian Phase I/IIa DIABECELL® trial
22 November 2012: Sydney, Australia and Auckland, New Zealand – Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced the results of an interim analysis of its Argentinian Phase I/IIa clinical trial for DIABECELL®, a breakthrough treatment for people with unstable type 1 diabetes.
The results clearly demonstrated a clinically significant reduction in HbA1c, insulin dose and unaware hypoglycaemia, with greater benefit being seen in the patient group receiving the higher dose of DIABECELL.
The trial, which is ongoing, involves eight patients split into two groups of four. Group one received two 5,000 IEQ/kg doses of DIABECELL (islet equivalents per kilogram of body weight). Group two received two 10,000 IEQ/kg doses of DIABECELL. In both groups, the second dose was implanted 12 weeks after the first. At the time of this interim analysis, group one patients were at 24 weeks follow up after the second transplant, and group two patients were at 12 weeks follow up after the second transplant.
In the second group of patients (those receiving the higher dose of two implants of 10,000 IEQ/kg) the most significant clinical benefits were:
insulin dose reduced by 20%
• a reduction of HbA1c from a pre-transplant average of 8.6% to an average of 6.7% at 12 weeks following the second implant
• up to 70% reduction in unaware hypoglycaemic events.
“Most type 1 diabetic patients who cannot attain reasonable control of their disease by conventional intensive insulin treatment would welcome the degree of control achieved with two doses of DIABECELL,” said Professor Bob Elliott, Chief Scientific and Medical Officer, LCT. “The reduction in both average daily insulin dose and HbA1c is clear demonstration of the positive effect of the DIABECELL transplant.”
DIABECELL is the first islet transplant treatment that does not require ongoing administration of debilitating immunosuppression drugs. DIABECELL is owned by the joint venture company Diatranz Otsuka Limited, in which LCT and Otsuka Pharmaceutical Factory both have a 50% interest.
“This interim analysis has been used to inform our 20 patient Phase IIb study, the start of which has also been announced today,” said Dr Andrea Grant, Chief Executive, LCT. “With each trial analysis we grow increasingly confident that DIABECELL will bring many benefits to patients with unstable type 1 diabetes, and we remain intently focused on reaching the market by 2016.”
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For further information: www.lctglobal.com
Diabetes is usually treated with insulin replacement. A serious and potentially fatal complication associated with intensive insulin replacement therapy is unaware hypoglycaemia. Episodes of unaware hypoglycaemia occur when, without associated symptoms or warning, blood glucose levels drop suddenly. Some patients require significant time and resources from specialist healthcare professionals and have a poor prognosis: lower quality of life, more micro vascular and pregnancy complications and shortened life expectancy.
Treatment with DIABECELL® involves transplanting pig pancreatic islet cells into a patient’s abdomen to boost insulin production and help regulate blood glucose levels. The cells are encapsulated with IMMUPEL™ to prevent the immune system rejecting them as foreign. This proprietary technology ensures the cells can deliver their beneficial effects without the patient requiring immunosuppressant drugs.
DIABECELL is owned by the joint venture company Diatranz Otsuka Limited, in which LCT and Otsuka Pharmaceutical Factory both have a 50% interest.
For a summary of DIABECELL’s clinical trial programme please see the DIABECELL clinical trial update on LCT’s website www.lctglobal.com or DIABECELL clinical trial update.
About Living Cell
Living Cell Technologies (LCT) leads the world in developing cell-based therapeutics to treat diseases with high unmet clinical need. Its proprietary cell encapsulation technology IMMUPEL™ allows for cell transplantation without the need for immunosuppressant drugs.
LCT’s lead therapeutic candidate DIABECELL® is indicated for the treatment of patients with type 1 diabetes, especially those suffering from life threatening episodes of unaware hypoglycaemia (low blood sugar), a dangerous and potentially fatal diabetes complication. DIABECELL is currently in Phase II clinical trials in both New Zealand and Argentina.
In 2011, LCT formed a partnership with Otsuka Pharmaceutical Factory Inc (OPF) in which the joint venture Diatranz Otsuka Limited (NZ) was established. Valued at A$50m on formation, LCT vested the DIABECELL product and associated IP into the JV, while OPF vested A$25m to fund the final phase of development of DIABECELL through to market approval. Both LCT and OPF are 50:50 shareholders in the current and future value generated by DIABECELL and the associated IP.
LCT has also developed NTCELL®, a choroid plexus cell product, to treat neurodegenerative diseases such as Parkinson’s disease and stroke. NTCELL’s trial results indicate potential for protecting, repairing and possibly regenerating brain tissue which would otherwise die.
LCT is incorporated in Australia. Research and development, operations and manufacturing facilities are based in New Zealand.