Human stem cell tests could be near
The CEO of Geron is planning embryonic stem cell tests in humans this
spring if the biotech meets the FDA's "high bar."
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See all CNNMoney.com RSS FEEDS (close) By Aaron Smith, CNNMoney.com
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February 12 2008: 8:12 AM EST
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NEW YORK (CNNMoney.com) -- The first experiments using human
embryonic stem cells in human subjects could begin within a few
months, the chief executive of biotech Geron said Monday.
At the annual BIO CEO conference in New York, Dr. Thomas Okarma said
Geron plans to start embryonic stem-cell studies in humans with
spinal cord injuries toward the end of the second quarter. Okarma
said the tests would involve up to 40 human patients, while all prior
tests involved rats.
This assumes that the Food and Drug Administration gives Geron a
green light to proceed with the human test. Okarma said the FDA will
set a "high bar" in regulating this new type of science.
Ren Benjamin, analyst for Rodman & Renshaw, believes the regulatory
process could be time-consuming, because it's unprecedented.
"This is the first time that a human embryonic stem cell application
is being submitted to the FDA, so there's a good chance that some
questions will arise," he said.
Geron (GERN), based in Menlo Park, Calif., is also in early-stage
studies with stem cell-based drugs for diabetes and heart failure.
All of these experimental treatments are years away from potentially
entering the market.
Privately held biotechs Advanced Cell Technology Inc. and Novocell
Inc. also use human embryonic stem cells, but Geron is the only one
of the these companies that's traded on the Nasdaq. Advanced Cell
plans to begin testing in humans this year, but Novocell is further
behind.
Cytori Therapeutics (CYTX) and Osiris Therapeutics (OSIR) use stem
cells taken from adult human tissue, which insulates from the
controversy surrounding the use of human embryonic stem cells, which
are obtained through in vitro fertilization.
Human-based embryonic stem cells are prized by researchers for their
ability to regenerate quickly and morph into different types of
cells. Supporters believe their use could someday help people with
spinal injuries walk again or cure patients with degenerative
diseases like Alzheimer's and Parkinson's.
But the pro-life contingent, including President Bush, opposes using
human-derived stem cells, on the grounds that it creates embryos only
to destroy them. Supporters of the science dispute that notion,
saying that the blastocysts used as stem cell sources would be thrown
out as medical waste if they weren't used in research.
In 2001, President Bush limited federal funding for human-derived
stem cells to only those lines that existed at the time. In 2007, he
vetoed a Congressional bill to lift those restrictions.
But in November, scientists unveiled a new type of experimental
technology on Nov. 21 that sent Geron's stock into a volatile
tailspin. Research teams from the University of Wisconsin in Madison
and the University of Kyoto in Japan separately announced that
they'd "reprogrammed" adult cells to act like embryonic stem cells.
Geron's stock has fallen more than 40% since then, though Okarma
shrugged off the potential threat of reprogramming because it's still
in the infantile stages.
"The natural human embryonic stem cell is the gold standard and we
have yet to see anything else come close," Okarma said at the BIO CEO
conference Monday
But Benjamin of Rodman & Renshaw doesn't believe reprogramming poses
an immediate threat to Geron.
"I think [reprogramming] is very intriguing and has a lot of
potential, but it's at a nascent stage that I consider more noise
than anything else," said Benjamin.
Mark Gross, a physics professor at California State University who
was attending the BIO CEO conference as a potential investor, agreed
that reprogramming technology is in too early of a stage to threaten
Geron.
"[Reprogramming] is promising, but these things take time and we
don't know which path will lead to fruition and which will lead to a
dead end," he said.
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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