Press Release – Living Cell Technologies
16 November 2012: Sydney, Australia and Auckland, New Zealand – Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) has received ethical approval from the New Zealand Ministry of Health’s Health and Disability Ethics Committee to proceed with Phase …
Living Cell Technologies Limited
Ethical approval for LCT’s NTCELL® Phase I trial
16 November 2012: Sydney, Australia and Auckland, New Zealand – Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) has received ethical approval from the New Zealand Ministry of Health’s Health and Disability Ethics Committee to proceed with Phase I clinical trials of NTCELL® for Parkinson’s disease.
“We are extremely pleased to have received ethical approval in such an efficient timeframe,” says Dr Andrea Grant, Chief Executive of LCT. “It means that LCT is still on track to commence NTCELL’s first in-human trials in Q1 2013.
LCT received regulatory authorisation from Medsafe to proceed with trials in October.
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For further information: www.lctglobal.com
About Living Cell Technologies
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.