FDA Hearings on Stem-Cell Drugs
By ALICIA MUNDY
April 10, 2008; Page D3
The contentious debate over embryonic-stem-
a new chapter as biotech companies press the Food and Drug
Administration to approve clinical trials for the first generation of
stem-cell-derived drugs.
The FDA has set two days of hearings starting Thursday to discuss how
the agency may regulate embryonic stem-cell therapies. FDA officials
say they expect the hearing will draw a crowd of biotech executives,
investors and researchers, and representatives of patient-advocacy
groups.
The biotech industry and investors want more certainty about the
FDA's guidelines for the complex approval process ahead, and
assurance that the FDA isn't averse to approving embryonic-stem-
therapies for political reasons.
One company involved in the hearings, Geron Corp., of Menlo Park,
Calif., is set to file what it says is the world's first embryonic-
stem-cell proposal with the FDA. If approved, the company could begin
human testing of a therapy to repair acute spinal injury. The company
expects to submit its proposal this summer.
During a conference call with investors this year, executives touted
the upcoming FDA panel. "We are actually playing a very central
role," said Chief Executive Tom Okarma, adding that the FDA had
invited Geron to give "a major presentation.
President Bush vetoed a bill backing federal funds for embryonic-stem-
cell research in 2007. But White House spokesman Tony Fratto said the
administration allows therapies generated from stem-cell research and
that he wasn't aware of any objections to the FDA moving forward.
Some industry executives fear the FDA is being pushed into
establishing standards too quickly, in light of concerns about
ethics, efficacy and safety.
"The FDA is nervous. It's under tremendous pressure. They can't
appear adversarial but they can't seem to be rolling over for
industry, either" said Richard Garr, CEO of Neuralstem Inc., which
develops adult-stem-cell products. Mr. Garr said he is worried that
if the hearings focus on unresolved safety problems in embryonic-stem-
cell technology the FDA could decide to slow down the process of
considering stem-cell therapies. "It's my nightmare scenario," he
said.
The hearings could provide a stage for some companies to make a
splash about new cell-based drugs in development or to prod the FDA
on shifts in the way it judges safety standards for embryonic-stem-
cell therapies. The FDA is reviewing other stem-cell-based
technologies, but embryonic stem cells are prized because they can
regenerate quickly and act like almost any other cell in the body.
"There is now enough of a critical mass to have this meeting," said
FDA spokeswoman Karen Riley.
Concerns remain that embryonic stem cells can trigger benign tumors
called teratomas.
"There's always an issue for the FDA with novel technologies" on how
to evaluate safety, said Celia Witten, director of the agency's
office of cellular, tissue and gene therapy.
One of the most-critical problems the FDA must tackle is how to
determine the length of time for a stem-cell trial in animals before
proceeding to human testing, Dr. Witten 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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