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First US embryonic stem cell trial is halted

health-and-fitness Updated: Nov 16, 2011 08:41 IST

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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 yesterday it was also cutting 66 full-time jobs, or 38% of its workforce.

"Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrollment," 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 trial of embryonic stem cell therapy on humans.

Another company, Advanced Cell Technology, began its first-ever trial on a form of juvenile blindness earlier this year, followed by a second on people with a type of macular degeneration. Those trials are ongoing.

In Geron's phase I trial, which was 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 programs and assets are widely recognised as being among the world's most comprehensive and advanced," Scarlett said, describing the move as a "business decision."

"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 USD 25 million per year for the next several years."

Geron said in its statement that it now expected to "end 2011 with cash and investments in excess of USD 150 million."