Spinal gap: Neuralstem goes into chronic injuries phase I trial first ever to be cleared by the FDA

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By Randy Osborne, Staff Writer
With encouraging data from a phase I trial in amyotrophic lateral
sclerosis (ALS) and a phase II trial under way testing NSI-566,
Neuralstem Inc. has begun – with the same candidate – the fi rst
human neural stem cell study to be given the FDA’s nod for chronic
spinal cord injury.
Four patients with thoracic spinal cord injuries (T2-T12) will
have NSI-566 transplanted directly into the region of the injury,
which has been sustained between one and two years before the
treatment. All patients have an American Spinal Injury Association
grade A level of impairment, which means complete paralysis with
no motor or sensory function at and below the trauma site.
Richard Garr, CEO of Germantown, Md.-based Neuralstem, said
the trial is half the size originally planned, and for a good reason.
“When we submitted this originally, there were eight patients, but
that was before we had treated successfully the high-dose patients
in our ALS trial,” he told BioWorld Today. “We went back to the FDA
and asked them to amend the protocol.”
Last heard from in the stem cell/spinal cord injury space was
Menlo Park, Calif.-based Geron Corp., which last year disclosed in
an SEC fi ling that the assets related to the program were taken
over by Asterias Biotherapeutics Inc., a subsidiary of regenerative
medicine specialist Biotime Inc., of Alameda, Calif.
The deal involved transfers of common stock and warrants, along
with patents, regulatory fi lings and investigational new drug
applications fi led with the FDA for Geron’s phase I safety study
with the oligodendrocyte progenitor cells (OPCs). Geron was
investigating the cells’ effi cacy in acute spinal cord injury, rather
than chronic, as with the Neuralstem product. In May of this
year, Asterias offered promising safety results with AST-OPC1, a
population of cells derived from human embryonic stem cells
that contain the OPCs, in fi ve subjects tested during a restarted
experiment that Geron began in 2010. (See BioWorld Today, Jan.
26, 2009, Jan. 27, 2009, and April 5, 2013.)
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FDA won’t just let you go in to try. The surgery is very risky. We’re
the first ones who ever did intraspinal injections with our ALS trial.”

Neuralstem had to use a special delivery device invented
at Cleveland Clinic, and deliver strong preclinical data
to U.S. regulators before efforts could move ahead. The
fi rm’s approach is “very different from what anybody else,
even Geron, has ever done,” he said.
Predicting how fast benefi t might appear is tricky. “In ALS
patients, the maximum window of biological activity for
the cells was between four and six months post-surgery,”
Garr said. “But it was also very clear in four to eight weeks
that there was considerable biological functional activity.
Will we see that in spinal cord patients? We don’t know,
but that would be our expectation.”
For some ALS patients, the effects turned up much sooner,
he added. “What the cells are doing here, in chronic
[spinal cord injury] patients, is literally bridging the gap.
We’re trying to rebuild the circuitry in the gap so that the
signal can come through, down the spinal cord. There are
also a lot of neurotrophic factors expressed by the cells
that can help with healing, but in a chronic patient, it’s
unknown how much impact that will have.”
Garr cited a key difference between spinal cord injury and
ALS, “where you are putting the cells in the motor neuron
pools to protect and nurture the remaining motor neurons
and then hopefully nurture back to health those that
haven’t hit that tipping point. The early neurotropic factor
expression of the cells, even before they are synaptically
integrated and matured, could have an effect [in ALS] –
clearly has. Maybe in spinal cord injury patients, where the
neurotrophic effect isn’t the primary reason for benefi t,
it could take a little longer. We’re really waiting for the
synaptic connections to happen and for the circuitry to be
rebuilt.”