Tuesday, November 15, 2011

Geron Flight from hESC Research is 'Powerful Blow'

The news about Geron's abrupt departure from hESC research is rippling around the world this morning, casting a pall over the entire field.

The Financial Times of London, in a story by Andrew Jacksaid,
"Geron, the pioneering stem cell therapy company, has dealt a powerful blow to one of the most hyped areas of medicinal research by withdrawing entirely from the field."
Ron Leuty at the San Francisco Business Times said in an analysis,
"Just why would I want to invest in a space where one of the most promising companies just called it quits."
In a Washington Post article by Rob Stein, a patient advocate expressed bitterness.
"'I’m disgusted. It makes me sick,' said Daniel Heumann, who is on the board of the Christopher and Dana Reeve Foundation. 'To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.'"
Geron, based in the San Francisco peninsula city of Menlo Park, cited financial problems when it announced yesterday that it was giving up on its stem cell efforts in favor of its cancer drug program. Geron is laying off 38 percent of its staff and says it will try to find a buyer for the stem cell program. Geron also settled its accounts with the California stem cell agency, which loaned it $25 million last May amidst considerable publicity.

The stem cell agency and other advocates expressed optimism about the long term potential of the field and noted the difficulties of bringing any therapy to production. Geron produced 21,000 pages of material over a years-long period to get FDA permission to begin only the first step in the long clinical trial process.

But the dominant tone of the news stories was negative. Heidi Ledford of Nature said Geron is "walking out on the field." Steve Johnson of the San Jose Mercury News said the decision casts "a cloud over the commercial viability of stem cell treatments."

Here are other excerpts:

San Francisco Business Times:
"What does this mean for companies that the California Institute for Regenerative Medicine, the state’s stem cell research funding agency, is pushing toward clinical trials? Will they only get so far before they, too, exit the business?" 
Fergus Walsh, medical correspondent for the BBC(see here), wrote:
"The decision does seem to be extraordinary given the huge investment of time and resources. When I visited Geron nearly three years ago, the then chief executive claimed the technology had an incredible future. 
"John Martin, professor of cardiovascular medicine at University College London said: 'The Geron trial had no real chance of success because of the design and the disease targeted. It was an intrinsically flawed study. And for that reasons we should not be describing this as a set back. 
"The first trials of stem cell that will give an answer are our own in the heart. The heart is an organ that can give quantitative data of quality.'"
Ryan Flinn of Business Week wrote,
"Geron fell 16 percent to $1.86 in extended trading. The shares have declined 58 percent this year.  
Robert Lanza, chief scientific officer of Advanced Cell Technology Inc.(of Santa Monica, Ca.), the second company to win permission from the U.S. Food and Drug Administration to test human embryonic stem cells in people, said the news wasn’t surprising, given the small patient population affected with spinal cord injuries. 
"'It was a very difficult choice to go in and treat spinal cord injury,' Lanza said in an interview. 'There was considerable concern in the scientific community that that might not have been the ideal first indication."
As first reported by the California Stem Cell Report, Geron's loan application was scored as a 66 on a scale 100 last May by scientific reviewers for the California stem cell agency. The score was not disclosed publicly at the time CIRM directors approved the award as has been the practice for all the other 400-plus awards that the agency has granted. The Geron approval process departed radically from the agency's regular procedures.

The news coverage in California of the Geron decision was marked by the absence of a story in the Los Angeles Times, the state's largest circulation newspaper. The San Francisco Chronicle carried only a brief story buried on page 6 of its business section. The California stem cell agency is based in San Francisco and the Bay Area contains one of the larger and more important biotech business and academic research communities in the world. Sphere: Related Content

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