Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,516.27 98.74 0.68%
TOPIX 1,173.37 6.78 0.58%
HANG SENG 22,760.24 64.23 0.28%

StemCells, Inc. Receives FDA Authorization of IND for Spinal Cord Injury



StemCells, Inc. Receives FDA Authorization of IND for Spinal Cord Injury

NEWARK, Calif., Oct. 2, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM)
announced today that the U.S. Food and Drug Administration (FDA) has
authorized the Company's Investigational New Drug (IND) application for
clinical testing of the Company's proprietary HuCNS-SC® human neural stem
cells as a treatment for spinal cord injury. As a first action under this IND,
the Company is working to open U.S. sites for its Phase I/II clinical trial
for chronic spinal cord injury, which is currently underway in Switzerland and
Canada. 

"This IND is a significant step forward for our spinal cord injury program,"
said Stephen Huhn, MD, FACS, FAAP, Vice President, CNS Clinical Research at
StemCells, Inc.  "With regulatory authorization from Switzerland, Canada and
now the United States, we have the first international trial of a stem cell
therapy for spinal cord injury.  To date, we have transplanted seven patients
from Germany, Norway, Italy, Israel, Canada, and the United States at Balgrist
University Hospital in Zurich. We now look forward to enrolling patients at
U.S. and Canadian sites and easing the travel burden for North American-based
patients. Our goal is to complete enrollment in the trial by the first quarter
of next year. This is the Company's fourth FDA-authorized IND, and the agency
has now cleared clinical studies of our HuCNS-SC cells in all three elements
of the CNS, the brain, the eye and the spinal cord." 

Roman Reed, President of the Roman Reed Foundation, added, "This is great news
for the spinal cord community. StemCells has not seen any safety issues in the
ongoing trial, and they have reported truly exciting preliminary results, with
gains in sensory function persisting for 12 months after transplantation. With
this green light from the FDA, it will be much easier for American patients to
participate in this innovative trial. This is another step forward in our
quest to find a cure for paralysis." 

The Roman Reed Foundation (www.romanreedfoundation.com) is a charitable
organization dedicated to the cause of finding cures for neurological
disorders, in particular the alleviation of spinal cord injury paralysis. 

About the Spinal Cord Injury Clinical Trial

The Company's Phase I/II clinical trial is designed to assess both safety and
preliminary efficacy of HuCNS-SC cells as a treatment for chronic spinal cord
injury. The Company plans to enroll twelve patients with thoracic
(chest-level) neurological injuries at the T2-T11 level, with the injury
classified as complete or incomplete according to the American Spinal Injury
Association Impairment Scale. To date, seven patients have been enrolled and
transplanted with HuCNS-SC cells. 

All patients who enroll will receive HuCNS-SC cells through direct
transplantation into the spinal cord and will be temporarily
immunosuppressed. Patients will be evaluated regularly in the post-transplant
period in order to monitor and assess the safety of the HuCNS-SC cells, the
surgery and the immunosuppression, as well as to measure any change in
neurological function below the injury site. Preliminary efficacy will be
evaluated based on defined clinical endpoints, such as changes in sensation,
motor function and bowel/bladder function. The Company intends to follow the
effects of this therapy long-term, and each of the patients will be invited to
enroll into a separate four-year observational study after completing the
Phase I/II study. 

Data from the first three patients, each of whom had suffered a complete
injury prior to enrolling in the study, showed multi-segment gains in sensory
function in two patients twelve months after transplantation of the HuCNS-SC
cells. One of the two converted from a complete injury classification to an
incomplete injury. The third patient remained stable twelve months after
transplantation. 

The trial is currently enrolling at Balgrist University Hospital, University
of Zurich, a world-leading medical center for spinal cord injury and
rehabilitation. Patients who may qualify and are interested in participating
in the study should contact the Zurich site either by phone at +41 44 386 3901
or by email at stemcells.pz@balgrist.ch. The Company is working to open trial
sites in Canada and the United States.

Information about the clinical trial is available at the ClinicalTrials.gov
website of the National Institutes of Health at
http://www.clinicaltrials.gov/ct2/show/NCT01321333?lead=StemCells+Inc.&rank=4.
Additional information about the Company's spinal cord injury program can be
found on the StemCells, Inc. website at
http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at
http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm.

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization
of cell-based therapeutics and tools for use in stem cell-based research and
drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC®
cells (purified human neural stem cells), is currently in development as a
potential treatment for a broad range of central nervous system disorders. In
a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal
myelination disorder in children, the Company has shown preliminary evidence
of progressive and durable donor-derived myelination in all four patients
transplanted with HuCNS-SC cells. The Company is conducting a Phase I/II
clinical trial in chronic spinal cord injury in Switzerland, Canada and the
United States, and has reported positive interim data for the first three
patients. The Company is also conducting a Phase I/II clinical trial in dry
age-related macular degeneration (AMD) in the United States. In addition, the
Company is pursuing preclinical studies in Alzheimer's disease, with support
from the California Institute for Regenerative Medicine (CIRM).  StemCells
also markets stem cell research products, including media and reagents, under
the SC Proven® brand. Further information about StemCells is available at
http://www.stemcellsinc.com.

Apart from statements of historical fact, the text of this press release
constitutes forward-looking statements within the meaning of the Securities
Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended,
and is subject to the safe harbors created therein. These statements include,
but are not limited to, statements regarding whether the improvements in
sensory function seen in the Company's Phase I/II clinical study of spinal
cord injury will persist and whether they will prove to be clinically
meaningful; continued authorization to conduct a clinical trial in
Switzerland, Canada and the United States in chronic spinal cord injury; the
timing and prospect of securing clinical trial sites in Canada and the United
States to conduct the Company's Phase I/II trial in spinal cord injury; the
prospect for screening and then enrolling additional patients with incomplete
spinal cord injury; the prospect for evaluating trial patients for changes in
their sensation, motor function and bowel/bladder function; the potential of
the Company's HuCNS-SC cells to treat spinal cord injury and other central
nervous system diseases and disorders; and the future business operations of
the Company. These forward-looking statements speak only as of the date of
this news release. The Company does not undertake to update any of these
forward-looking statements to reflect events or circumstances that occur after
the date hereof. Such statements reflect management's current views and are
based on certain assumptions that may or may not ultimately prove valid. The
Company's actual results may vary materially from those contemplated in such
forward-looking statements due to risks and uncertainties to which the Company
is subject, including the fact that additional trials will be required to
demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the
treatment of any disease or disorder; uncertainty as to whether applicable
regulatory agencies will permit the Company to continue clinical testing in
spinal cord injury or in future clinical trials of proposed therapies for
other diseases or conditions; uncertainties regarding the Company's ability to
recruit the patients required to conduct its clinical trials or to obtain
meaningful results; uncertainties regarding the Company's ability to obtain
the increased capital resources needed to continue its current and planned
research and development operations; uncertainty as to whether HuCNS-SC cells
and any products that may be generated in the future in the Company's
cell-based programs will prove safe and clinically effective and not cause
tumors or other adverse side effects; uncertainties regarding the Company's
ability to commercialize a therapeutic product and its ability to successfully
compete with other products on the market; and other factors that are
described under the heading "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended December 31, 2012, and in its subsequent reports
on Form 10-Q and Form 8-K.

CONTACT: Rodney Young
         StemCells, Inc.
         Chief Financial Officer
         (510) 456-4128
        
         Ian Stone
         Russo Partners
         (619) 308-6541

company logo
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement