Wow. That’s it? Eighteen years in the stem cell trenches, millions in R&D, a big-time stem cell clinical trial in the works and sky-high expectations from patients and investors, and the plug is pulled? Just like that?
Can’t say it’s a complete surprise, having watched the Geron burn rate over the past few years. Last year, losses exceeded $110 million. So far in 2011, about $60 million. Totally unsustainable. But to just turn away from the whole field?
Unless a partner comes to the rescue, Geron Corp. is through with stem cells and is ditching its landmark acute spinal cord injury trial, the first approved use of embryonic stem cells (eSC) in a clinical setting.
This is indeed a major blow to the notion that eSC could return function to people the way the cells seemed to in rats.
Chalk it up to “the current environment of capital scarcity and uncertain economic conditions," according to Geron’s CEO Dr. John A. Scarlett. He came aboard just six weeks ago and quickly took out the hatchet. He decided the company would drop stem cells altogether and work on cancer therapies.
Scarlett says it’s not science, it’s just money. “I deeply believe in the promise of stem cells. I don’t think that promise is in any way, shape or form changed by what we’re doing.”
But seriously, does that mean cancer is where the real money is, not in nerve trauma, or does it mean Geron’s SCI trial was in over its head and so obviously underwhelming that it deserved to be spiked?
Geron had a lot riding on this trial – millions of investor capitol, intellectual property (they were early supporters of the University of Wisconsin team that first developed eSC) and they had a huge share of the public imagination. This was one of the highest profile companies in any industry, especially in biotech. The SCI trial was arguably the most-watched human experiment ever.
In the SCI cure community, Geron was heroic. A beacon of hope. A pioneer. This trial, even though targeted at acute SCI, has been closely watched for a number of years, dating to 2003 and the early work of UC Irvine scientist Hans Keirstead; his eSC-treated rats got better and that led to the trial.
Despite the outsized spin, there were lots of bystanders in the science community who didn’t think Geron should have moved so forcefully into the ethical and technical eSC maelstrom. Just because an application to the FDA was 20,000 pages long doesn’t convince the field that the preclinical animal data was adequate. And there are those who think spinal cord trauma was probably the wrong indication for the debut of eSC.
You have to give the company credit, I guess, for taking the risk, doing the work, almost sticking to it through the hard part. The trial, approved last year after months of delays and wrangling with the FDA, enrolled just four patients. Recent reports indicate no adverse effects. These four will continue to be monitored but unless a partner emerges no others will join them.
Geron’s exit leaves Advanced Cell Technology as the only company now conducting a clinical trial using human embryonic stem cells. It has fated embryonic cells to become retinal cells, hoping to treat two forms of macular degeneration, which can cause blindness. So far, results have not been reported.