By Randy Osborne, Staff Writer
Neuralstem Inc.’s $19.65 million from a stock offering will help
advance the lead compound NSI-566 in amyotrophic lateral sclerosis
(ALS), which is “about halfway through” a Phase II trial, said CEO
Richard Garr.
Rockville, Md.-based Neuralstem is selling about 6.7 million shares
at $2.91 each in the offering. Each investor also gets a warrant to
buy half the number of shares purchased. Warrants bear an exercise
price of $3.64, and can be exercised for fi ve years.
Shares (NASDAQ:CUR) closed Friday at $2.97, down 19 cents.
Expected to close next week, the offering’s proceeds will get
Neuralstem through Phase II in the ALS effort with spinal cordderived
stem cells, as well as the small-molecule program, where
the company has “just completed a Phase Ib trial in major depressive
disorder,” Garr told BioWorld Today. “We’re looking at the data now,
and anticipate sometime in this quarter fi ling for a Phase II.”
Stem cell trials are neither much more expensive nor much cheaper
than tests of other therapies. “That’s always in the eye of the
beholder, isn’t it?” Garr noted. “Drug trials, especially for depression,
are expensive. Everybody knows what the FDA expects and what the
parameters are. It doesn’t cost us any more or any less than anybody
else.”
Cell therapy as a whole is “fairly expensive,” he said. “In terms of the
dollars per patient, it’s very expensive, but in terms of the numbers
of patients, because it’s fairly small, the overall cost is manageable.”
The Phase II trial in ALS got funding help from the National Institutes
of Health and from the ALS Association, he said.
“We have to wait six months after the last surgery for the trial to
end,” Garr said. “Sometime near the end of this calendar year, the
Phase II [in ALS] should be over completely.”
Neuralstem’s approach represents the world’s fi rst intraspinal
injections of stem cells. “This is a targeted surgery at various
segments of the spinal cord, and the cells actually go into the
motor neuron pools in those segments and synaptically integrate,”
Garr said. “There have been, in the past, people who have tried to
put what you would think of as adult stem cells – all kinds of bone
marrow and blood stem cells and things like that – into the spinalfl
uid cavity,” though such experiments took place “mostly in Mexico
and in Germany and other places,” as well as China, he said.
“Our approach is unique, actually rebuilding the circuitry,”
Garr said. “These cells don’t fl oat up and down in the spinal
fl uid, and they don’t migrate to the spinal cord. They’re going
in and creating new circuitry inside very specifi c segments
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groups of muscles, he noted. In ALS patients, when the
muscles that control breathing and swallowing give way, so
do the patients, not long afterward.
HUMAN DATA FUELING STOCK
Neuralstem also has been given clearance by the FDA to
start a spinal cord injury trial in complete paralysis patients,
using the same technology.
“Geron, of course, famously, had an approval from the FDA
[for trials] with their oligodendrocyte progenitor [GRNOPC-1]
cells to try to treat spinal cord injury,” Garr said. “I believe
they may have actually transplanted two or three patients
before they pulled the plug.”
Menlo Park, Calif.-based Geron last April 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 cells. (See BioWorld Today, Jan. 26, 2009, Jan.
27, 2009, and April 5, 2013.)
“The mechanism of action by the cells, even though it’s the
same cells, is a little different [in spinal cord injury, where]
the idea is literally to build new circuitry to bridge the gap,
to bring function back to paralyzed patients,” Garr said. “In
ALS, even though patients lose their ability to walk, it’s not
because there’s a break in the signal coming down the spinal
cord from the brain. It’s because the muscles have atrophied
and died. Our main goal here is to improve the quality of life
and extension of life for these patients, is to keep them off
breathing machines for as long as possible.”
Neuralstem’s shares have been on the climb for about a
year. ”We don’t really talk about the stock that much,”
Garr said, because market changes are too hard to explain,
in most cases. “The clear answer is, there’s no substitute
for human data,” and interim data have been showing up in
presentations.
“A publication is coming out, we expect, on the Phase I trial [in
ALS],” he said. “Some of the patients went public, and it was
in Newsweek. It was pretty clear, just from a lay perspective,
they were seeing a defi nite benefi t to a number of patients, and
long term, not just marginal but signifi cant, quantitative actual
improvement that no one has seen before, and that has lasted
a very long time.”
