TeGenero's TGN1412 Victim update

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http://www.theregister.co.uk/2006/04/05/drug_trial_off_critical/

 

Final drug trial victim out of the woods

 

By Chris Williams

Published Wednesday 5th April 2006 16:03 GMT

 

All of the volunteers given an experimental immune

drug in a London trial have now made it off the

critical list at Northwick Park hospital.

 

The last of six men given biotech firm TeGenero's

TGN1412 compound is now fully conscious and looks set

to make a full recovery. [sic]

 

Intensive care clinical director Dr Ganesh

Suntharalingam said: " We are delighted that the six

patients have come through safely from the most

critical stage of their condition. "

 

He praised intensive care staff for how they dealt

with the victims' very serious condition when they

were transferred there from a private testing unit

more than three weeks ago.

 

TeGenero said today its preliminary investigations

showed it had followed all correct procedures in the

animal testing phase of the drug. It also says the

problem was unforseeable based on preclinical results

(see here

(http://www.theregister.co.uk/2006/03/20/tegenero_trial_science/)

for why many think the problems might have been

foreseeable though).

 

Watchdog the Medicines and Healthcare products

Regulatory Agency (MHRA) agreed, saying it hasn't been

able find a problem with how the trial was carried

out.

 

It also couldn't find evidence of contamination of the

drug. Some had speculated bacterial toxins might be

responsible for the multiple organ failure.

 

MRHA added that its findings are not yet conclusive,

but that the suspected flaws

(http://www.theregister.co.uk/2006/03/20/tegenero_trial_science/)

in the action of the drug itself were the most likely

cause. The Secretary of State for Health is assembling

a panel of experts to investigate why the animal

trials didn't pick up the near-deadly complications.

 

Meanwhile, Raste Khan, 23, one of the men given a

harmless placebo, appeared in The Sun today, saying he

was still traumatised by what he saw during the

trials. " I still feel haunted by it and I know my

family have been extremely upset. I am too frightened

even to get sleeping pills from the doctor. "

 

He claims test contractor Parexel is demanding he

honour the terms of his contract by attending

follow-ups in order to pocket his £2,000 volunteer

fee.

 

Testing contractor Parexel was unavailable for

comment. ®

 

Two drug trial victims released (28 March 2006)

http://www.theregister.co.uk/2006/03/28/two_tegenero_volunteers_released/

 

The science behind the human guinea pig drug trial (20

March 2006)

http://www.theregister.co.uk/2006/03/20/tegenero_trial_science/

 

Friends and families deal with drug trial fallout (16

March 2006)

http://www.theregister.co.uk/2006/03/16/drug_trial_latest/

 

UK drugs trial hospitalises six (15 March 2006)

http://www.theregister.co.uk/2006/03/15/drug_trial/

 

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