16 November 2011

Embryonic stem cell trial halted

The first-ever trial using human embryonic stem cells to treat paralysis has been halted due to high costs, and the company will focus instead on new cancer treatments, Geron said.


The first-ever trial using human embryonic stem cells to treat paralysis has been halted due to high costs, and the company will focus instead on new cancer treatments, Geron said.

The California-based biotech firm, which had bypassed federal funding to get its pioneering but controversial trial off the ground in October 2010, said it was also cutting 66 full-time jobs, or 38 percent of its workforce.

Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrolment, the company said in a statement, adding that the decision was made after a strategic review of costs and regulatory complexities.

The study was meant to include up to 10 people in the first-ever trial of embryonic stem cell therapy on humans.

No harmful effects 

Another company, Advanced Cell Technology, followed months later with its first-ever trial on a form of juvenile blindness. ACT's trials are ongoing.

In Geron's phase I trial, which is meant primarily to gauge safety, the therapy showed no harmful effects on the four patients enrolled so far, the company said.

Geron chief executive John Scarlett told a conference call of investors that the company was seeking partners to take up the costs of the stem cell unit, which it began in 1999.

Deciding to move out of the stem cell business was a very difficult decision to make. Our stem cell programmes and assets are widely recognised as being among the world's most comprehensive and advanced, Scarlett said, describing the move as a business decision.

Therapies hold great promise

Let me be very clear that in this trial, the treatment has been well tolerated with no serious adverse events reported, he added. These therapies have held and continue to hold great promise.

Geron plans to focus instead on a pair of cancer treatments that are in phase II studies.

"We are making these changes because in the current environment of capital scarcity and uncertain economic conditions, we need to focus our resources," Scarlett said.

The company's chief financial officer, David Greenwood, said that without the changes, Geron would have "expected to incur stem cell related R and D (research and development) costs of approximately R201 million per year for the next several years."

Treated like rats

Geron said in its statement that it now expected to end 2011 with cash and investments in excess of R1 210 billion.

The decision was greeted with anger by a board member of the Christopher and Dana Reeve Foundation, founded by the late Superman actor and his wife and which aims to cure spinal cord injury by funding new paths of research.

I'm disgusted. It makes me sick, board member Daniel Heumann was quoted as telling the Washington Post.

To get people's hopes up and then do this for financial reasons is despicable. They are treating us like lab rats.

Ban lifted

Those who support embryonic stem cell research believe the field holds great promise for a host of ailments, from Alzheimer's to diabetes and more.

But the research is controversial because it requires the destruction of human embryos, and opponents say it violates their religious beliefs and is unethical.

Federally funded stem cell research was halted under the George W. Bush administration, and though President Barack Obama lifted the ban in 2009, several legal battles have followed.

Scientists have also complained that a rush for patents on nearly every step of the process has made it almost impossible to advance their work.

(Sapa, November 2011) 

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