Geron Soars as First Stem-Cell Test in Humans Cleared

Geron Corp. gained the most in more than five years in Nasdaq trading after the company won approval from U.S. regulators to begin the first human test of embryonic stem cells on humans.

The stem-cell test will attempt to restore movement to paralyzed people by injecting nerve cells made from embryonic cells to the site of injury. The U.S. Food and Drug Administration today lifted a hold placed on the research last May after Geron persuaded regulators the procedure is likely to be safe, said Thomas Okarma, chief executive officer of the Menlo Park, California-based company.

The shares jumped by $2.48, or 54 percent, to $7.69 in composite trading at 12:35 p.m. New York time. They earlier climbed 61 percent, the biggest increase since more than tripling on March 18, 2003, when Geron reported that its method for developing a vaccine against cancer may be useful against different types of the disease.

While thousands of patients around the world have been treated with adult stem cells and have shown mixed results, no humans have been given cells derived from embryos in an approved trial. Geronís test will provide the first look at whether embryonic stem cells can regenerate.

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Because the extraction of the cells leads to the destruction of human embryos, former President George W. Bush barred federal funding for stem-cell colonies created after 2001.

President Barack Obama, like many Democrats and some Republicans in Congress, backs such research, as does his pick for science adviser, Thomas P. Holdren. Bushís limitation led to reduced support for academic and corporate research on embryonic stem cells. Obama said during his campaign that he favored overturning the restriction.

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The company will now seek approval from the ethics boards of seven medical centers around the U.S. to begin conducting the study with the goal of beginning to treat patients this summer, Okarma said. While he declined to estimate how long it might take to complete all the studies and seek FDA clearance to market the therapy, he predicted that early success would speed the process.
Biotech with stemcells becomes an interesting stock to watch