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February 7, 2006 -
BioWorld Today
International
Symposium On Stem Cell Collaboration
ReNeuron's Results Positive As Stem Cell Meeting Starts
By Randall Osborne
West Coast Editor
SAN FRANCISCO - Just
before a unique meeting on stem cell research got under way here,
preclinical news from the UK boosted hopes for the field as applied
to stroke.
ReNeuron Group plc aims to file an investigational new drug
application and begin dosing humans this year, based on findings
from a second study with ReN001, a therapy for chronic disability
after stroke.
"Everything is on track," said John Sinden, Guildford, UK-based
ReNeuron's chief scientific officer, pointing out that data from the
second study in rodent models reinforce results from the first
study, with delivery method and implant location selected to mimic
as much as possible the protocols likely to be followed in human
trials.
The new data back up the first set in another way, he told BioWorld
Today.
"We've used cells that have been banked - they're derived from GMP
lots, equivalent to the clinical lots that will go into the
patients," Sinden said. "The original studies were done with, as it
were, early materials."
What's more, the latest results show a dose-ranging effect,
suggesting that a higher dose has the potential to reverse both the
sensory and motor symptoms from stroke. In September, ReNeuron held
a formal pre-investigational new drug application meeting with the
Center for Biologics Evaluation and Research component of the FDA.
The company's headlines hit just ahead of the one-day International
Symposium on Stem Cell Collaboration today at the University of
California at San Francisco. Sponsored by the Women's Technology
Cluster (WTC), a business incubator dedicated to women leaders
building technology-driven firms, the event is intended to "help get
the dialogue going early" between academia, companies and would-be
investors, said Cori Gorman,
president of DNA Bridges,
a San Francisco-based consulting firm for biotech and pharma.
"We're scientists with business experience," said
Gorman, who serves on
the board of trustees of the WTC. She spent 10 years at South San
Francisco-based Genentech Inc., and co-founded the gene therapy firm
Valentis Inc., of Burlingame, Calif.
Although Valentis recently reported stock-boosting Phase IIb data
with its lead candidate VLTS 934, a nonionic block copolymer that
acts as a vascular lubricant in patients with peripheral arterial
disease, gene therapy mostly has struggled, and that struggle partly
inspired Gorman to
find ways of advancing the dialogue.
Planning for the stem cell event began in the fall of 2004, but the
WTC decided "it was a little early then,"
Gorman said. "We
needed a few more successes on the basic research side" - successes
like ReNeuron's.
"What's beautiful about their work is that they have found a way to
make the cells last a long time in the undifferentiated state,"
Gorman told BioWorld
Today . "They understand that you need to have them stable and
reproducible, and then be able to remove whatever trigger that is
letting them remain in a stem cell-like state. Geron [Corp., of
Menlo Park, Calif.] is also trying to do this."
ReNeuron's GMP ability with cell lines makes the company more ready
for FDA scrutiny, too, and "that's something gene therapy missed out
on a little bit. They weren't thinking about what the FDA would
want."
Ultimately, Gorman
said, "some of the things going on in academia" tipped the scale in
favor of putting the symposium together. She mentioned work on
rodent spinal cord regeneration in the lab of Brian Cummings at the
University of California at Irvine, and research on heart
regeneration by the likes of Nadia Rosenthal in Italy and scientists
at the University of Minnesota.
StemCells Inc., of Palo Alto, Calif., in July entered a licensing
deal with ReNeuron that gives the former exclusive access to the
latter's c-mycER adult human stem cell immortalization technology
for use in developing therapies for lysosomal storage diseases,
spinal cord injury, cerebral palsy and multiple sclerosis. In
return, ReNeuron got exclusive access to StemCells' adult neural
stem cell patent estate for the development of its own c-mycER
conditionally immortalized neural stem cell therapies for stroke, as
well as Parkinson's disease and Huntington's disease.
As part of that arrangement, StemCells has taken a 7.5 percent fully
diluted equity interest in ReNeuron, and the agreement provides for
reciprocal royalties and milestone payments.
"That [deal] is a key one for us," Sinden said, calling StemCells "a
very big player in the U.S."
After neural applications, he said, ReNeuron's "next stage is to
work with [the technology] in other types of stem cells, and we
already have some projects under way," at the preclinical stage.
His firm's approach is "different, because [ReNeuron uses] clonal
cell lines, so there's an element of genetic modification, but all
of that is understood from the regulators' point of view," Sinden
said. "They like what they see, in terms of how we're operating."
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