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November 15, 2011 10:37 am
Geron, the Californian biotech company, is abandoning its pioneering embryonic stem cell work after concluding that the costs and length of further development were too great.
It said the “clinical, manufacturing and regulatory uncertainties” of stem cell research during difficult economic times had forced it to dismiss nearly two-fifths of its employees and refocus on its other experimental treatments, which are for cancer.
The decision reflects the tough environment for biotech companies struggling to find funding during the downturn.
It is also a setback for the fledgling and much-hyped stem cell sector, as well as for patients with spinal injuries, the group targeted by Geron for its groundbreaking trial with GRNOPC1. This is a therapy developed from embryonic stem cells, which are extracted from in vitro fertilised eggs, modified and injected into patients.
John Scarlett, Geron’s chief executive, said: “By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital. This would not be possible if we continue to fund the stem cell programs at the current levels.”
But John Martin, professor of cardiovascular medicine at University College London, cautioned: “The trial had no real chance of success because of the design and the disease targeted. The first trials of stem cells that will give an answer are our own in the heart. The heart is an organ that can give quantitative data of quality.”
More than 2,700 trials are taking place globally using adult stem cells, but Geron last year became the first company to begin tests in patients using embryonic stem cells. Advanced Cell Technology of the US has since begun two other trials for eye conditions.
Mr Scarlett said he was in discussions with potential partners including “several global companies” to pursue its stem cell research, which Geron estimated would cost $25m annually for several years to complete. “We still think [the field] has tremendous promise,” he said.
Stephen Kelsey, chief medical officer, said four of the planned eight patients had so far been recruited into the study and would still be monitored. He said the trial – which was designed only to test for safety – had so far shown neither any serious adverse effects nor efficacy.
Geron is eliminating 66 full-time positions, and expects one-time cash expenditures of approximately $5m in the fourth quarter of 2011 and approximately $3m in the first half of 2012. Geron expects to end 2011 with cash and investments in excess of $150m.
Stephanie Williams, chief executive of the Spinal Cord Injury Network, called the decision “a great loss”.
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