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 The data will also be withdrawn from all regulatory documentation.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The publication is being withdrawn following an internal quality assurance (QA) audit which showed that the source data for the study held on file at LCT are incomplete and therefore the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

 

Future Brighter Money: RBNZ Releases New Bank Note Designs

New Zealand’s banknotes are getting brighter and better, with the Reserve Bank today unveiling more vibrant and secure banknote designs which will progressively enter circulation later next year. More>>

ALSO:

Commerce: Supermarket Inquiry Finds No Breaches By Countdown

The Commerce Commission inquiry into anti-competitive behaviour by Countdown supermarkets, alleged by former Labour Party MP Shane Jones, has found nothing to warrant prosecution, although it warns supermarkets to take care in the way they communicate... More>>

ALSO:

Crown Accounts: English Flags ‘Challenge’ To Budget Surplus

Finance Minister Bill English is warning next month’s half yearly fiscal and economic update from the Treasury may not forecast a budget surplus, saying that returning the government’s accounts to surplus in 2015 will be “a challenge”, given the decline in commodity prices and weak global inflation. More>>

ALSO:

March 2015: Netflix To Launch In Australia And New Zealand

World’s Leading Internet Television Network to Offer Original Series, Movies, Documentaries, Stand-Up Comedy Specials and TV Shows for Low Monthly Price More>>

ALSO:

Price Of Cheese (Is Up): Dairy Product Prices Fall To Five-Year Low

Dairy product prices fell in the latest GlobalDairyTrade auction to the lowest level in more than five years, led by declines in rennet casein and skim milk powder. More>>

ALSO:

Gordon Campbell: On The Australians Scoring Trade Points Against Us With The Chinese

It hasn’t been a great year for Trade Minister Tim Groser... To top it off, Australia has just signed a FTA with China that has far better provisions on dairy exports than what New Zealand currently enjoys in our own FTA with China. More>>

ALSO:

Iwi & Local Consultation: Oil And Gas Block Offer 2015 Begins

Energy and Resources Minister Simon Bridges today announced the start of the Block Offer 2015 process for awarding oil and gas exploration permits. More>>

Industrial Action: Stats NZ Throwing Public Money Away Duplicating Data

The Public Service Association (PSA) says Statistics NZ are throwing money away by collecting the same data twice for official statistics such as the Consumer Price Index... As part of the ongoing industrial action, field interviewers who are PSA members are continuing to collect data, but are not sending it through to Statistics NZ. More>>

ALSO:

Other Stats:

Space: Rosetta's 'Philae' Makes Historic First Landing On A Comet

After more than a decade traveling through space, a robotic lander built by the European Space Agency has made the first-ever soft landing of a spacecraft on a comet. More>>

ALSO:

Get More From Scoop

 
 
Standards New Zealand

Standards New Zealand
 
 
 
 
 
 
 
 
Sci-Tech
Search Scoop  
 
 
Powered by Vodafone
NZ independent news