Why did Geron "fail" in its
much ballyhooed pursuit of the first-ever human embryonic stem cell
therapy?
research scholar at Stanford, and Brady Huggett,
business editor of the journal Nature, took a crack at
answering that question in a commentary in the June edition of
Nature.
fall by Geron of its hESC business and the first-ever clinical trial
of an hESC therapy, Scott and Huggett scrutinized the history of the
company. The financial numbers were impressive. They wrote,
"How did Geron’s R&D program
meet such a demise? After all, the company raised more than $583
million through 23 financings, including two venture rounds, and
plowed more than half a billion dollars into R&D (about half of
that into hESC work) through 2010.
"There are problems with being at
the forefront of unknown territory. Of Geron’s development efforts,
the hESC trial was the most prominent, and fraught. Therapies based
on hESCs were new territory for the US Food and Drug
Administration (FDA), and it eyed Geron warily. The
investigational new drug application (IND), filed in 2008, was twice
put on clinical hold while more animal data were collected among
fears that nonmalignant tumors would result from stray hESCs that
escaped the purification process. Geron says it spent $45 million on
the application, and at 22,000 pages, it was reportedly the largest
the agency had ever received."
bet $25 million on the company just a few months before it pulled the
plug. Geron repaid all the CIRM money that it had used up to that point.
despite its vaunted stem cell patent portfolio. Scott and Huggett
reported that Geron received only $69 million from 1992 to 2010 from
collaborations, license and royalties. At the same time losses were
huge – $111 million in 2010.
was occurring while other biotech companies – such as Isis
and Alnylam – found ample financial support, revenue and
success.
final comment to Advanced Cell Technology, now the only
company in the United States with a clinical trial involving a human
embryonic stem cell therapy.
"Your technology may be
revolutionary, your team may be dedicated and you may believe. But it
does not matter if no one else will stand at your side."
agency obviously has learned something from its dealings with Geron.
The company's hESC announcement was an unpleasant surprise, to put it
mildly, coming only about three months after CIRM signed the Geron
loan agreement. Today, however, the agency has embarked on more,
equally risky ventures with other biotech enterprises. Indeed, CIRM
is forging into areas that conventional investment shuns. It is all
part of mission approved by California voters in 2004.
stem cells or even adult stem cells is alluring. And CIRM is feeling
much justifiable pressure to engage industry more closely. All the
more reason for CIRM's executives and directors to maintain a steely
determination to terminate research programs that are spinning their
wheels and instead pursue efforts that are making significant
progress in commercializing research and attracting other investors.
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Recommendation and review posted by Fredricko
