Video | Business Headlines | Internet | Science | Scientific Ethics | Technology | Search

 


Withdrawal of NTCELL pre-clinical study

Living Cell Technologies Limited

CAN: 104 028 042

ASX: LCT

OTCQX: LVCLY

ASX ANNOUNCEMENT

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 The data will also be withdrawn from all regulatory documentation.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The publication is being withdrawn following an internal quality assurance (QA) audit which showed that the source data for the study held on file at LCT are incomplete and therefore the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 –

© Scoop Media

 
 
 
 
 
Business Headlines | Sci-Tech Headlines

 

Half Empty: Fonterra's 2017 Opening Forecast Below Expectations

Fonterra Cooperative Group raised its forecast farmgate milk payout for next season by less than expected as the world's largest dairy exporter predicts lower prices will crimp production and supply will pick up. The New Zealand dollar fell. More>>

ALSO:

Pest Control: Mouse Blitz Team Leaves For Antipodes

The Million Dollar Mouse project to rid Antipodes Island of mice is underway with the departure of a rodent eradication team to the remote nature reserve and World Heritage Area. More>>

Gongs Got: Canon Media Awards & NZ Radio Awards Happen

Radio NZ: RNZ website The Wireless, which is co-funded by NZ On Air, was named best website, while Toby Manhire and Toby Morris won the best opinion general writing section for their weekly column on rnz.co.nz and Tess McClure won the best junior feature writer section. More>>

ALSO:

Pre-Budget: Debt Focus Risks Losing Opportunity To Stoke Economy

The Treasury is likely to upgrade its forecasts for economic growth in Budget 2016 next week but Finance Minister Bill English has already signalled that more of his focus is on debt repayment than on fiscal stimulus or tax cuts... More>>

ALSO:

Fulton Hogan's Heroes: Managing Director Nick Miller Resigns

Fulton Hogan managing director Nick Miller will leave the privately owned construction company after seven years in charge. The Dunedin-based company has kicked off a search for a replacement, and Miller will stay on at the helm until March next year, or until a successor has been appointed and a transition period completed. More>>

ALSO:

Gordon Campbell: On Electricity, Executions, And Bob Dylan

The Electricity Authority has unveiled the final version of its pricing plan for electricity transmission. This will change the way transmission prices (which comprise about 10% of the average power bill) are computed, and will add hundreds of dollars a year to power bills for many ordinary consumers. More>>

ALSO:

Half Empty: Fonterra NZ, Australia Milk Collection Drops In Season

Fonterra Cooperative Group says milk collection is down in New Zealand and Australia, its two largest markets, in the first 11 months of the season during a period of weak dairy prices. More>>

ALSO:

Get More From Scoop

 
 
 
 
 
 
 
 
 
Sci-Tech
Search Scoop  
 
 
Powered by Vodafone
NZ independent news