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Geron Clinical Trial Halted

In a huge surprise, Geron announced on November 14 that they were halting their clinical trial of stem cells for spinal cord injury, and indeed, were getting out of the business of stem cells entirely.  Instead, they will focus on drugs they have in the pipeline for cancer.  This was apparently strictly a business decision, and was not triggered by any adverse event in the people who have received stem cells.  Geron announced that it will continue to follow the patients who received stem cells, but will not enroll any new patients except for patients who were already in the pipeline.  And in fact, two days after Geron’s announcement, a 5th patient received a stem cell transplant at Stanford University. 

This doesn’t affect any of the research at the RIRC.  Geron doesn’t fund anything that is going on here right now, and in fact hasn’t funded anything for several years since the early studies by Hans Keirstead that formed the basis of the trial.  It is likely to be seen as a big symbolic setback, however because the pipeline from the lab to the clinic has suddenly been shut down.

What does Geron’s surprising decision mean for the future development of stem cells for clinical applications?  It’s really too early to say, but progress in developing stem cell therapies will likely be slowed, at least for now.  Geron had invested tens of millions on this trial, and was the undisputed leader of the companies in the field. On the other hand, this isn’t the only trial going on right now, or the only trial involving stem cells for spinal cord injury.

Geron has announced that it will try to sell its stem cell assets, and perhaps some other company will step in to continue what Geron started.  But the Geron team that supported the program will lose their jobs, and if another company takes up the program, they will have to re-assemble a team to support the program.  Some companies have apparently expressed an interest, but we will have to wait and see whether and how this happens.

Only the management team at Geron knows exactly what calculations drove the decision.  From the beginning, it was clear that the first trial would take at least 2 years, and that moving from the initial safety trial through to the point that there could actually be an approved therapy would take several years more.  It was also clear that the trials would cost a lot of money. Maybe the continuing situation with the economy made it impossible to continue to raise capital for something that would take as long as the trials certainly would have.  One lesson is that there are economic challenges to developing stem cell therapies that had not been fully appreciated, at least by most people. This could mean that other companies will take a hard look before starting down the path, at least for now.

Another possible lesson is that we may need to re-think the model for moving scientific discoveries to the clinic, especially for stem cell applications.  The model has been that once the discovery was made and enough pre-clinical work had been done, then further development would be by private companies who could anticipate a profitable product in the end.  The problem with this model is that at any point in the process, a company may decide to abandon a promising direction that doesn’t promise a profit in a reasonable time frame.  That’s what seems to have happened here. 

One alternative model is a much greater involvement of academic centers in product development.  Development of a therapeutic product might have to be driven in part by philanthropy rather than venture capitalists.  The people who donate would not be able to expect windfall profits, but would be assured that success would improve the lives of people.

It’s important not to lose sight of the fact that Geron blazed a trail by establishing a path to FDA approval for stem cell therapies.  There are other trials ongoing, including the trial sponsored by Stem Cells Inc. that is based on the discoveries of Aileen Anderson and Brian Cummings here at the Reeve-Irvine Research Center.   And there are other promising discoveries pointing the way toward potential therapies that don’t involve stem cells.  Very important lessons were learned in setting up the Geron trial that will carry over to other trials of interventions during the acute post-injury period.

We knew from the beginning that the development of new stem cell treatments would not be without setbacks.  It is good that the setback here was not due to a problem with the treatment itself.   Also, the 5 people who already received stem cell transplants will be followed, providing hugely important safety information regarding stem cell implants into the nervous system.

 

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