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 The data will also be withdrawn from all regulatory documentation.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The publication is being withdrawn following an internal quality assurance (QA) audit which showed that the source data for the study held on file at LCT are incomplete and therefore the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

 

Cosmetics & Pollution: Proposal To Ban Microbeads

Cosmetic products containing microbeads will be banned under a proposal announced by the Minister for the Environment today. Marine scientists have been advocating for a ban on the microplastics, which have been found to quickly enter waterways and harm marine life. More>>

ALSO:

NIWA: 2016 New Zealand’s Warmest Year On Record

Annual temperatures were above average (0.51°C to 1.20°C above the annual average) throughout the country, with very few locations observing near average temperatures (within 0.5°C of the annual average) or lower. The year 2016 was the warmest on record for New Zealand, based on NIWA’s seven-station series which begins in 1909. More>>

ALSO:

Farewell 2016: NZ Economy Flies Through 2016's Political Curveballs

Dec. 23 (BusinessDesk) - New Zealand's economy batted away some curly political curveballs of 2016 to end the year on a high note, with its twin planks of a booming construction sector and rampant tourism soon to be joined by a resurgent dairy industry. More>>

ALSO:


NZ Economy: More Growth Than Expected In 3rd Qtr

Dec. 22 (BusinessDesk) - New Zealand's economy grew at a faster pace than expected in the September quarter as a booming construction sector continued to underpin activity, spilling over into related building services, and was bolstered by tourism and transport ... More>>

  • NZ Govt - Solid growth for NZ despite fragile world economy
  • NZ Council of Trade Unions - Government needs to ensure economy raises living standards
  • KiwiRail Goes Deisel: Cans electric trains on partially electrified North Island trunkline

    Dec. 21 (BusinessDesk) – KiwiRail, the state-owned rail and freight operator, said a small fleet of electric trains on New Zealand’s North Island would be phased out over the next two years and replaced with diesel locomotives. More>>

  • KiwiRail - KiwiRail announces fleet decision on North Island line
  • Greens - Ditching electric trains massive step backwards
  • Labour - Bill English turns ‘Think Big’ into ‘Think Backwards’
  • First Union - Train drivers condemn KiwiRail’s return to “dirty diesel”
  • NZ First - KiwiRail Going Backwards for Xmas
  • NIWA: The Year's Top Science Findings

    Since 1972 NIWA has operated a Clean Air Monitoring Station at Baring Head, near Wellington... In June, Baring Head’s carbon dioxide readings officially passed 400 parts per million (ppm), a level last reached more than three million years ago. More>>

    ALSO:

    Get More From Scoop

     
     
     
     
     
     
     
     
    Sci-Tech
    Search Scoop  
     
     
    Powered by Vodafone
    NZ independent news