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Withdrawal of NTCELL pre-clinical study

Living Cell Technologies Limited

CAN: 104 028 042




Withdrawal of NTCELL pre-clinical study

19 December 2013 – Sydney, Australia & Auckland, New Zealand – Living Cell Technologies Limited today announced that it is withdrawing the publication of the pre-clinical study of the effects of NTCELL in a rat model of Parkinson’s disease. The data will also be withdrawn from all regulatory documentation.

The study in question was conducted by LCT between 2007 and 2009, and the results published in The Journal of Regenerative Medicine in 2011[1].

[1 SJM Skinner, H Lin, MS Geaney, T Gorba, RB Elliott, PL J Tan, titled “Restoration of motor control and dopaminergic activity in rats with unilateral 6-hydroxy-dopamine lesions” was published in Regen. Med 2011; 6: 319-326. ]

The publication is being withdrawn following an internal quality assurance (QA) audit which showed that the source data for the study held on file at LCT are incomplete and therefore the efficacy conclusions in the publication cannot be confirmed.

The withdrawal of the rat efficacy data does not in itself present a safety risk with regard to the use of NTCELL in humans. Nonetheless, as a precautionary measure LCT has placed a hold on any further patient recruitment into the human Phase I/IIa clinical study that is currently underway at Auckland City Hospital. This is to allow the company to work with the New Zealand medicines regulator (Medsafe) and the data safety monitoring board (DSMB) to fully understand the impact of the withdrawal of the rat efficacy data on the Phase I clinical trial.

Dr Andrea Grant, Managing Director of Living Cell Technologies said, “Regular quality audits of source data are a founding principle of LCT’s commitment to the safety of patients in our clinical trials. It is most unusual for these audits to result in the withdrawal of data from a clinical trial application, but our priority as a commercial company is always on patient safety and therefore full disclosure. Whilst it is reassuring to know the withdrawal of the efficacy data does not pose safety risks, it is the right and proper thing to do to place the trial on hold whilst we thoroughly investigate the findings of the audit.”

The first person implanted with NTCELL in the Phase I/IIa study continues to do well since their implant in September 2013. They will continue to be managed by the clinical team according to the clinical trial protocol. The patient’s explicit request for privacy remains in place.

LCT and Otsuka Pharmaceutical Factory (OPF) are co-developing NTCELL as a treatment for Parkinson’s disease. A second cash payment of A$2m which was due from OPF to LCT as a result of the DSMB authorising the recruitment of the remaining three patients to the study is now not expected to be received until patient recruitment into the trial is recommenced.

– Ends –

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