UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of Earliest Event Reported):
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October 7, 2014
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StemCells, Inc.
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(Exact name of registrant as specified in its charter)
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Delaware
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000-19871
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94-3078125
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(State or other jurisdiction
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(Commission
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(I.R.S. Employer
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of incorporation)
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File Number)
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Identification No.)
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7707 Gateway Blvd, Suite 140, Newark, California
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94560
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code:
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510.456.4000
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Not Applicable
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Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On October 7, 2014, StemCells, Inc. (the "Company") issued a press release announcing the initiation of its Pathway Study, a Phase II proof of concept clinical trial using the Company's proprietary HuCNS-SC platform of human neural stem cells for the treatment of cervical spinal cord injury.
A copy of this press release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibit
Exhibit 99.1 Press release dated October 7, 2014 announcing initiation of the Company's Phase II clinical trial in spinal cord injury.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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StemCells, Inc.
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October 8, 2014
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By:
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Kenneth Stratton
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Name: Kenneth Stratton
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Title: General Counsel
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Exhibit Index
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Exhibit No.
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Description
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99.1
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Press release dated October 7, 2014
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StemCells, Inc. Initiates Phase II Clinical Trial in Cervical Spinal Cord Injury
First study assessing efficacy of neural stem cells for the treatment of cervical spinal cord injury
NEWARK, CA, October 7, 2014 (GLOBE NEWSWIRE) StemCells, Inc. (Nasdaq:STEM) a world leader in
the research and development of cell based therapies for the treatment of disorders of the central
nervous system announced today that it has initiated its Pathway® Study a Phase II proof
of concept clinical trial using its proprietary HuCNS-SC® platform of human neural stem
cells for the treatment of cervical spinal cord injury (SCI). Approximately 1.3 million people in
the United States, report being paralyzed due to a SCI, and there currently are no effective
treatments available. Approximately 56% of the spinal cord injuries occur in the cervical region.
Overall, approximately 13% of SCI patients have no mobility and 35% have limited mobility after the
traumatic injury.1
The Pathway Study is the first clinical study designed to evaluate both the safety and efficacy of
transplanting stem cells into patients with traumatic injury to the cervical spinal cord. The trial
will be conducted as a randomized, controlled, single-blind study and efficacy will be primarily
measured by assessing motor function according to the International Standards for Neurological
Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change
in upper extremity strength as measured in the hands, arms, and shoulders. The trial will follow
the patients for one year from the time of enrollment.
Earlier this year, the Company completed enrollment in an open-label Phase I/II clinical trial in
thoracic SCI and reported interim results from this trial on eight patients with at least six
months of follow-up post transplantation. Half of the patients transplanted had significant
post-transplant gains in sensory function. The interim results also continue to confirm the
favorable safety profile of the cells and the surgical procedure. Based upon the strength of the
interim data from its thoracic SCI study, the Company made the decision to move forward with the
first in human clinical trial to assess the efficacy of stem cell transplants for the treatment of
cervical SCI.
The initiation of the Pathway Study represents a major milestone for StemCells, Inc. as we pursue
the development of a truly breakthrough therapy for spinal cord injury, said Martin McGlynn,
president and chief executive officer of StemCells, Inc. While we are thrilled by the prospect
that patients with thoracic level injuries might be able to regain lost sensory function below the
site of the injury, the possibility that patients with injuries to the cervical region of the cord
might regain or improve lost motor function could be truly life-changing.
The first site initiated into the Pathway Study is the University of Miami Miller School of
Medicine, home to The Miami Project To Cure Paralysis, one of the worlds most comprehensive
research centers dedicated to finding more effective treatments for, and ultimately a cure for,
paralysis.
Our center has been a leader in clinical research aimed at curing paralysis, said Allan D. Levi,
M.D., Ph.D., F.A.C.S., Robert M. Buck Distinguished Chair in Neurological Surgery at the University
of Miami Miller School of Medicine and principle investigator for the center. I have been involved
in pioneering research efforts in applying cellular transplants to treat spinal cord injury
patients for many years, and have closely followed the pre-clinical and clinical efforts of
StemCells. We are excited to be the first site to open this important clinical trial. This is a
time of promise and hope for victims of spinal cord injuries and, should this study be successful,
it moves us one step closer to our ultimate goal of curing paralysis.
About the Pathway Spinal Cord Injury Clinical Trial
The Companys Pathway Phase II clinical trial titled Study of Human Central Nervous System
(CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury, will evaluate the safety and
efficacy of transplanting the Companys proprietary human neural system stem cells (HuCNS-SC
cells), into patients with traumatic injury in the cervical region of the spinal cord. This is a
randomized, controlled, single-blind study with a primary endpoint of change from baseline in
ISNCSCI upper extremity motor scores. Patients will be followed for a period of twelve months post
enrollment.
Information about the Companys spinal cord injury program can be found on the StemCells, Inc.
website at:
http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm
Information for patients interested in participating in the study is available at the Pathway
website at:
http://www.sciresearchstudy.com
Additional information about the clinical trial is available at:
http://clinicaltrials.gov/ct2/show/NCT02163876?term=stem+cells+cervical+spinal+cord+injury&rank=1
About HuCNS-SC Cells
StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies
of its proprietary HuCNS-SC cells. StemCells clinicians and scientists believe that HuCNS-SC cells
may have broad therapeutic application for many diseases and disorders of the central nervous
system (CNS). Because the transplanted HuCNS-SC cells have been shown to engraft and survive
long-term, there is the possibility of a durable clinical effect following a single
transplantation. The Companys preclinical research has demonstrated that HuCNS-SC cells can be
directly transplanted in the CNS with no sign of tumor formation or adverse effects. The HuCNS-SC
platform technology is a highly purified composition of human neural stem cells that are expanded
and stored as banks of cells.
About StemCells, Inc.
StemCells, Inc. is a world leader in the research and development of cell based therapies for
the treatment of disorders of the central nervous system. The Companys platform technology,
HuCNS-SC cells (purified human neural stem cells), is currently in clinical development as a
potential treatment for a broad range of central nervous system disorders. 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 eight patients. The Company is
also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD) in the
United States, and has reported positive results on the first seven patients. 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. In addition, the Company is pursuing preclinical studies
in Alzheimers 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 .
Apart from statements of historical fact, the text of this press release constitutes
forward-looking statements within the meaning of the U.S. securities laws, 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 Companys Phase I/II clinical
study of spinal cord injury will persist and whether they will prove to be clinically meaningful;
the prospect for evaluating trial patients for changes in their sensation, motor function and
bowel/bladder function; the potential of the Companys HuCNS-SC cells to treat spinal cord injury
and other central nervous system disorders; and the future business operations of the Company,
including its ability to conduct clinical trials as well as its other research and product
development efforts. 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
managements current views and are based on certain assumptions that may or may not ultimately
prove valid. The Companys 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 Companys HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to
whether the FDA or other 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 Companys ability to recruit the patients
required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding
the Companys ability to manufacture viable cells sufficient to enroll the patients planned for the
Companys Phase II studies; uncertainties regarding the Companys 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 Companys cell-based programs will prove safe and clinically effective and not cause tumors or
other adverse side effects; and other factors that are described under the heading Risk Factors
in the Companys Annual Report on Form 10-K for the year ended December 31, 2013, and in its
subsequent reports on Form 10-Q and Form 8-K.
References:
1. Christopher & Dana Reeve Foundation: One Degree of Separation: Paralysis and Spinal
Cord Injury in the United States. 2009
CONTACT: Greg Schiffman
StemCells, Inc.
Chief Financial Officer
(510) 456-4128
Andrea Flynn
Russo Partners
(646) 942-5631
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