Stem cells get FDA approval for regrowth of nerve tissue

Friday 23rd January 2009

Whether President Obama's presidency or the UK Medicines and Healthcare Products Regulatory Agency approval for Guildford-based ReNeuron Group Plc to commence first clinical trial using its fetal stem cells has had anything to do with it, the US Food and Drug Administration has cleared the way for the US first study of human embryonic stem cell therapy, by Geron Corp. The California biotechnology company plans to start a clinical trial to try to use the stem cells to regrow nerve tissue in patients with acute spinal cord injury. As an augury it would seem to argue for ReNeuron also getting clearance.

"This marks the beginning of what is potentially a new chapter in medical therapeutics -- one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells," Geron CEO, Thomas Okarma (right) said in a statement. Geron shares rose nearly 30% to $6.75 in premarket electronic trading onNasdaq.

The FDA rejected the company's first request to conduct the trial of GRNOPC1, Oligodendroglial Progenitor Cells, putting the trial on hold in May.

"If GRNOPC1 eventually does become the first human Embryonic Stem Cell drug to receive an approved Biologic License Application it could be as important to drug therapy as the discovery of Salvarsan or penicillin," said drug analysts Stephen Brozak and Daniel Mallin of WBB Securities LLC.  Salvarssan was the first modern drug, used to treat syphilis early in the last century.

Joel Sendek of Lazard Capital Markets was cautious: "Cellular-based therapies carry substantially more regulatory risk than do traditional small-molecule drugs or protein therapeutics," he said.`

Former President George W. Bush had been at odds with Congress, researchers and advocates for years over the issue and by executive order restricted federal funding of work involving human embryonic stem cells.

President Barack Obama, who succeeded Bush on Tuesday, had been widely expected to rescind that directive. Although the FDA does not make decisions based on politics, the company made the decision public just days after Obama was sworn into office.


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