First stem cell trial halted due to costs
pharmafile | November 18, 2011 | News story | Research and Development | Geron, Stem cells
One of the world’s first stem cell trials has been put on hold due to ‘uncertain economic conditions’.
Geron, the firm undertaking the research, was treating patients with spinal cord injury using GRNOPC1, which contains human embryonic stem cells, in the first trial of its kind.
But the trial is now on hold due to the “current environment of capital scarcity and uncertain economic conditions”.
The firm added however that it was still ‘seeking partners for these novel assets’ to possibly re-start the trial in the future.
Geron plans to close the Phase I GRNOPC1 trial to further enrollment, although it will continue to follow all enrolled patients, accruing data and updating the FDA and medical community on its progress, it said in a statement.
The Californian biotech said it will now focus its resources on advancing the Phase II clinical trials of imetelstat and GRN1005, currently under investigation for a range of different cancers.
The decision comes after Geron reviewed the costs and regulatory complexities associated with its stem cell trial and found that it did not have the resources to carry on.
As a consequence Geron will cut 66 full-time positions, representing 38% of its workforce, and will pay around $8 million next year as a one-off cash expenditure.
However the firm said that in order to facilitate transfer of these programmes to potential new partners, Geron would retain a core group of employees from its stem cell operations through the end of the second quarter of next year.
Geron’s chief executive John Scarlett said: “Our employees, collaborators andshareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic.
“Stem cells continue to hold great medical promise. We believe that our leadership role in the field and the quality of our stem cell assets-which are widely recognised as being among the most innovative, comprehensive and advanced cell therapy programs in the world-will be an important point of differentiation in our discussions to partner these assets.”
This is not the first time the trial has been stopped – it was first given the go-ahead in January 2009 but halted nine months later due to safety concerns.
But in August last year the FDA gave the trial a green light, and Geron re-started its Phase I trial in December 2010.
Ben Adams
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