BioTime, Inc. (NYSE MKT: BTX) today announced that the clinical-grade human
Embryonic Stem (hES) cell lines from BioTime's wholly-owned subsidiary ES
Cell International Pte Ltd (ESI, Singapore) will be used by UC Irvine
scientist Dr. Leslie Thompson to continue her promising research in the use
of stem cells to treat Huntington's disease under a $5 million grant from
the California Institute for Regenerative Medicine (CIRM). The CIRM grant
will further support a collaboration between ESI and UC Davis's
good-manufacturing-practice (GMP) laboratory for the creation of the GMP
grade cells needed in Dr. Thompson's preclinical and potentially subsequent
clinical studies.
This collaboration is an example of BioTime's strategy to leverage
collaborations and potentially generate future revenues by placing its hES
cells in a wide array of medical applications that BioTime could not
otherwise address with its own resources. ESI provides its hES cells as both
inexpensive research-grade cells through its ESI BIO division and as
GMP-compliant clinical grade cells for translation into clinical
applications, allowing researchers to conduct research with hES cells that
can also be used in the clinic.
According to Dr. Thompson, Professor, Departments of Psychiatry and Human
Behavior and Neurobiology and Behavior at the Sue and Bill Gross Stem Cell
Center, "Huntington's disease is a devastating genetic neurodegenerative
disease that strikes individuals in the prime of life and can be passed on
for generations to come. There is no treatment that changes the onset or
course of the disease. The funding from CIRM for this preclinical
development grant will allow further preclinical evaluation of a lead stem
cell based treatment candidate, neural stem cells derived from BioTime's
ESI-017 stem cells, in consultation with the FDA. These cells have
demonstrable protective effects following transplantation in a mouse model
of Huntington's disease."
Gerhard Bauer, Associate Professor, Director of the GMP Laboratory at UC
Davis says, "For the funded project, GMP grade hES cells will be
manufactured at the UC Davis GMP facility and differentiated into GMP grade
neuronal stem cells (NSCs) which are slated for a human clinical application
for the treatment of Huntington's disease. In previous preclinical runs it
was found that the particular hES line, ESI-017, performed very well in
pluripotent cell expansion and studies, and reliably formed robust NSCs
after differentiation. In addition, a novel closed system hollow fiber
bioreactor will also be used for larger scale hES and NSC expansion. This is
the first time that GMP grade pluripotent stem cells will be applied for the
treatment of Huntington's disease."
Jeffrey Janus, ESI's CEO commented, "It is reported that approximately
30,000 people in the U.S. have Huntington's disease while another 150,000
have a 50% chance of developing the disease. Because of the protracted and
debilitating course of the illness, and the current lack of a cure,
Huntington's disease is said to cost the U.S. about $2.5 billion annually.
We are pleased and excited to be a part of this important work by Dr.
Thompson and her team at UC Irvine and UCLA and by Dr. Bauer and his GMP
cell manufacturing operation at UC Davis. This is further evidence that CIRM
funding and private investment in stem cell science can work together to
accelerate the translation of stem cell technology to clinical application."
Users of BioTime's hES cells may need to obtain a license or other
permission from Wisconsin Alumni Research Foundation or other third parties
to conduct research, perform clinical trials, or to make or sell any
products based on the ESI hES cells.
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