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November 16, 2011

Finances halt first-ever FDA approved human embryonic stem cell clinical trial

by Angela C.H. McDonald

The stem cell community was shocked to hear Geron Corporation’s announcement on Monday that the company will immediately discontinue its stem cell programs including its much-publicized Phase I clinical trial for the treatment of spinal cord injury. 

Following a strategic review of costs and regulatory hurdles involved with their stem cell program, Geron has decided to instead focus its efforts on ongoing cancer trials. Dr. John Scarlett, CEO of Geron Corporation announced yesterday that “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.”  

It should be noted that Dr. Scarlett assumed the role of CEO in September of this year. Scarlett is a cancer specialist, which has spurred questions whether this has influenced the decision to terminate Geron’s stem cell program.

It has been a long road for Geron to reach the Phase I clinical trail stage of their human embryonic stem cell trial. Years were spent in preclinical trials, where Geron successfully treated injured rats by injecting oligodendrocyte progenitor cells derived from human embryonic stem cells into spinal cord lesions, improving locomotion.   

In 2008, Geron initiated a Phase I trail but it was put on hold when in animal studies, microscopic cysts where found at injection sites. Additional preclinical studies resolved concerns around these cysts and Geron again initiated Phase I of this trial in October 2010.

Just a few weeks ago, Geron presented a clinical update for the Phase I trial at the Pre-Conference Symposia of the joint 2011 American Congress of Rehabilitation Medicine and American Society of Neuro-Radiology Annual Meeting in Atlanta. At this time, the cells had been administered to four thoracic spinal cord injury patients. Clinical data showed no indication of complications related to the surgical procedure or injected cells.However, Geron representatives did report a few minor problems related to immunosuppressive drugs.

Phase I clinical trials are meant to address safety of an experimental treatment and not meant to measure effectiveness.

Although the decision to end this trial appears to be a strategic move for Geron based on finances, many stem cell researchers are questioning whether Geron is throwing in the towel too soon for the wrong reasons. Reports late yesterday indicated the company's stocks were at an all time low following the announcement. Chatter in the stem cell field suggests that the four patients treated to date have shown no signs of efficacy. Could this be the real reason Geron is ending the trial? Many scientists favour this hypothesis (have a look at recent posts on the Knoepfler blog to see reaction and good further discussion on this topic). 

The premature end to the first FDA-approved human embryonic stem cell clinical trial comes as sad and surprising news to the stem cell community. The field is now left questioning what will happen to the future of embryonic stem cell research?  Will this event slow the translation of this research into the clinic?  Has Geron now set a precedent that human embryonic stem cell clinical trials are not worth the money? Not worth the risk? If Geron can’t afford to fund a human embryonic stem cell clinical trial, who can?

 

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The design of the trial would evaluate short term safety but not much else. Since a low dose, short term immune-suppression regimen was used, it is not expected the cells should survive past 60 days. So considering the trial design and the fact there were no adverse effects for any of the patients (days in trial: 30-365), the trial should be considered successful.

It is a sad day when the company leading the way to use embryonic stem cells in the clinic must abdicate this role. Despite all they have achieved, which will undoubtedly benefit the field in the near future, I would guess that the tremendous amounts spent to date plus the need for continued development, plus the non-pharma business model increasingly caused their board nervousness culminating in shutting down the program. I wonder what Steve Jobs would say...

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