Monday, January 26, 2009

Monday, January 26, 2009, 12:43pm EST | Modified: Monday, January 26, 2009, 1:05pm

Monday, January 26, 2009, 12:43pm EST Modified: Monday, January 26, 2009, 1:05pm
Neuralstem wins key patent for stem cell work
Washington Business Journal - by Vandana Sinha Staff Reporter

Joanne S. Lawton
Richard Garr, CEO of Neuralstem.View Larger
Neuralstem Inc. said Monday it has nailed down a key patent for its core technology, which grows neural stem cells from the brain to replace damaged spinal cord cells.
The patent comes in time for Neuralstem’s first clinical trials, planned for this year if the Food and Drug Administration gives them the green light. The Rockville company intends to test the ability and safety of injecting fetal stem cells into the spinal cords of patients suffering from amyotrophic lateral sclerosis, more commonly known as Lou Gehrig’s Disease.
Under the new patent, Neuralstem (AMEX: CUR) can grow almost unlimited numbers of stem cells from all parts of the brain, all in a controlled and consistent manner. The company has been honing its technology for the past 13 years, relying on fetal stem cells rather than their more controversial counterpart, embryonic stem cells.
Neuralstem filed its request in December to launch its first human clinical trials this spring. It expects to hear the FDA’s decision by the middle of next month, but another competitor’s recent news has raised its hopes. On Friday, the FDA approved a request by Geron Corp. to test embryonic stem cells in human trials for the first time, illustrating to Neuralstem leaders a growing comfort level at the agency with using previously untested stem cells to treat non-fatal diseases.
“It removes a tremendous amount of uncertainty,” said Neuralstem CEO Richard Garr. “It makes it clearer what’s required to make it forward [to trials]. From what we’ve seen, we’ve done what’s required.”
While he said President Barack Obama’s entry in the White House is more coincidental than influential in the FDA’s decision for Geron, he does foresee it opening more doors for stem cell discovery and science.
“There’s no question that the tone will be different,” Garr said. “The tone from the top will always have an impact.”
Garr points out the difference between the two companies’ techniques, however, saying a green light for Geron doesn’t necessarily guarantee one for Neuralstem. Whereas Geron is working to essentially restrip the neural “wires” that connect spinal cells to help heal traumatic spinal cord injury, Neuralstem is opting to fully replace destroyed spinal cord cells to treat ALS.
Before the end of the year, Neuralstem also hopes to start clinical trials of its technology on improving traumatic spinal cord injury, the same disease area as Geron, potentially placing Neuralstem in direct competition with the Menlo Park, Calif., company.
The local company raised more than $1.7 million in a stock offering at the end of last year --enough, Garr said, to pay for the ALS trials on an anticipated 15 patients.
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