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King's College London - Health: More than a medical matter

Geron issues statement on halted stem cell trial

06 September 2009

By Nishat Hyder

Appeared in BioNews 524

Information has come to light regarding the US Food and Drug Adminstration (FDA)'s freeze on the clinical trails of GRNOPC1, a groundbreaking therapy for spinal cord injury derived from human embryonic stem cells being undertaken by biotech company Geron. The FDA approved the commencement of clinical trails of GRNOPC1 in January 2009 amid much excitement: this was to be the first trial of its kind.

The halt, which was announced on 18 August, was not fully explained at the time by either the FDA or Geron. It appears that the FDA instigated the halt in order to review new information put before them by the company. Despite positive pre-clinical trials in animals, there have always been fears that the cells will differentiate uncontrollably causing tumours to develop.

These fears were allayed following new statements issued from Geron: the information being reviewed related to recent tests that revealed the formation of cysts in some (animal) trail subjects. Although cysts had been detected in earlier trials, the high frequency of cysts in recent trials caused concern. Geron has given assurances that the cysts are not dangerous - they are non-proliferative, and show no adverse effects, or increased health risks. Furthermore, the company stated that a batch of the GRNOPC1 drug, tested according to new markers and assays showed no cysts at all. No evidence of teratomas (a type of tumour) was found.

Geron's share price dropped 14 per cent following the latest suspension of the clinical trials, however it has since rallied. Joseph Pantginis of Merriman Curhan Ford explains: 'I believe that since the worst case scenario (teratomas) did not occur, investors are relieved.'

However, there is no indication of how long the review will take or when the clinical trials are likely to recommence. Pantginis rationalises the less-than-smooth drug trial process experienced so far: 'Geron is especially vulnerable because it is at the forefront, by far, of the embryonic stem cell space, and being on the cutting edge means the company must also be the first to hit the hurdles and learn as they go,' he said.

However, not all commentary has been positive. Analyst Adam Feurerstein is on record saying that 'the only thing Geron has done exceedingly well in its 13 years as a public company is surf the waves of stem cell hype and use that momentum to raise lots of money.'


Mercury News | 28 August 2009
Geron says some animals developed cysts in trial
Forbes | 28 August 2009
GEN News | 28 August 2009
Reuters | 27 August 2009


22 October 2012 - by Anna Cauldwell 
Two former CEOs of US drug company Geron are bidding to revive its stem cell assets... [Read More]
21 March 2011 - by MacKenna Roberts 
A US company has launched an experimental neural stem cell clinical trial for patients paralysed by spinal injury. StemCells Inc will extract neural stem cells from donated aborted fetuses to be injected into the spines of patients with chest-level spinal cord injury... [Read More]
23 November 2009 - by Alison Cranage 
Stem cell therapy came one step closer to being tested for the first time in people this week, as a US company applied to the Food and Drug Administration (FDA) for a licence to start a clinical trial. The embryonic stem (ES) cell therapy is being developed to treat Stargardt, a currently incurable disease that causes blindness in young people.... [Read More]
08 November 2009 - by Dr Jay Stone 
American company Geron Corporation (GC) has been given permission to resume its clinical trials testing the embryonic stem cell treatment GRNPOC1.... [Read More]
28 September 2009 - by Marianne Neary 
The US Food and Drug Administration (FDA) has granted approval to NeuralStem Inc., a Maryland-based biotherapeutics company, to conduct the first human trial using neural stem cells for treatment of amyotrophic lateral sclerosis (ALS). ALS is a type of motor neuron disease often referred to as 'Lou Gehrig's' and 'Maladie de Charcot'. The late-onset condition, of unknown cause, affects approximately two in 100,000 people, including the UK physicist Stephen Hawking and US rock gui... [Read More]

23 August 2009 - by Alison Cranage 
The US Food and Drug Administration (FDA) has delayed the start of a clinical trial that plans to use human embryonic stem cell(ES) cells to treat spinal cord injury. The trial is being run by Californian based company Geron. The FDA originally gave the go-ahead for the trial in January, but now has halted the start in order to review new data submitted by Geron.... [Read More]
26 January 2009 - by Antony Blackburn-Starza 
The US Food and Drug Administration (FDA) has allowed the biotech firm, Geron, to begin clinical trials using embryonic stem (ES) cells to help treat spinal cord injury sufferers who have become paralysed from the chest down. The product known as GRNOPC1 will be tested for its... [Read More]

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