Wednesday, August 19, 2009

Geron Travails a Reminder of Height of Stem Cell Hurdles

For those you who haven't seen the latest news on Geron, their latest hiccup -- if that is what it is -- demonstrates the arduous and tedious nature of bringing new stem cell therapies into the market.

Geron's plan to run a modest clinical trial on its spinal cord injury therapy has been suspended – before one person could be enrolled – as the result of FDA action. If it ever gets underway, it would be the first human trial using embryonic stem cells.

The company, which is based in Menlo Park, Ca., gave no reasons nor did the FDA, but one analyst cited possible safety concerns.

Geron has been in existence since 1990. It has never made a profit. It has no commercial products. And it has spent more than $150 million developing its spinal cord therapy, according to Steve Johnson of the San Jose Mercury News.

Geron has benefited from favorable coverage since announcing eight months ago it would start the trial. Adam Feurstein of TheStreet.com has a much more jaundiced view. However, he downplays the safety issue. Sphere: Related Content

1 comment:

  1. Anonymous7:44 AM

    Did Okarma really use an airbag excuse on an investor call?! Wow.
    I thought I read somewhere that the delay was due to concerns about new animal results on dose escalation. If true, this could be a serious setback, but might not be.

    I agree with Steve Johnson and Adam Feurstein though that Geron hasn't impressed in the execution department and unfortunately for investors and patients hoping for a cure, execution is 90% of success. Geron has received multiple passes for attempting to be first to the clinic with ES cells but it is looking like their inability to move forward has more to do with life science management than the pesky ES cell. Dose escalation studies and a strategy to overcome limitations should have been a no-brainer from the get go. To have this problem at the 11th hour is telling (if indeed that is the issue).

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