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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November 18, 2015
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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.
With this Form 8-K filing, StemCells, Inc. (the "Company") is providing an update on its two Phase II clinical programs and presenting interim data from the first cohort in its Phase II Pathway Study in spinal cord injury. While enrollment into the Company’s Phase II Radiant Study in dry AMD is taking longer than previously anticipated, both studies are actively enrolling at multiple sites in North America. Additional sites are being initiated in both studies and patient enrollment is expected to accelerate in 2016. The Company intends to provide an update on both of its Phase II clinical programs at its next analyst call.
The preliminary data from the Pathway Study show a pattern of overall motor improvement in four of the six patients comprising the first cohort in the study. These motor improvements consisted of gains in both upper extremity muscle strength and increases in measures of dexterity based on multiple clinical assessments. There have been no adverse events attributed to the cells.
A copy of the Company’s press release, which issued earlier today and summarizes the preliminary data from the Pathway Study, is attached to this Form 8-K as item 99.1.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibit 99.1 Press Release, dated November 18, 2015, announcing preliminary data from the Company's Pathway Study.
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 the future business operations of StemCells, Inc. (the "Company"); statements about the prospect and timing of patient enrollment in the Company's two Phase II studies and in particular whether enrollment rates will increase in 2016, if at all; statements about the nature and significance of the treatment effect seen in the Pathway Study; statements about whether the Company will be able to enroll additional clinical sites in either or both of its clinical programs; and statements about and the prospect for continued clinical development of the Company's HuCNS-SC cells in both spinal cord injury and dry AMD or in either program. 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 uncertainties about whether preliminary data in any Phase I or Phase II clinical study will prove to be reproducible or biologically meaningful in any future clinical study; risks whether the FDA or other applicable regulatory agencies, including applicable institutional review boards at one or more clinical trial sites, will permit the Company to continue clinical testing or conduct future clinical trials; 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 whether results in preclinical research in animals will be indicative of future clinical results in humans; uncertainties regarding the Company's manufacturing capabilities given its increasing clinical commitments; uncertainties regarding the validity and enforceability of the Company's patents; uncertainties as to whether the Company will become profitable; 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, 2014 and in its subsequent reports on Forms 10-Q and 8-K.
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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November 18, 2015
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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 November 18, 2015
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StemCells, Inc. Interim Trial Data Show Motor Improvement in Patients with Cervical Spinal
Cord Injury
Positive Six-Month Results, with Gains in Both Strength and Motor Function, for the First
Cohort in the Phase II Pathway Study
NEWARK, CA, November 18, 2015 (GLOBE NEWSWIRE) StemCells, Inc. (NASDAQ: STEM), a world
leader in the research and development of cell-based therapeutics for the treatment of disorders of
the central nervous system, today announced that the six-month interim results for the first cohort
in its ongoing Phase II Pathway Study in cervical spinal cord injury (SCI) showed motor
improvements in both strength and function. The assessment of motor function involved using tests
of dexterity.
Patients eligible for the study have complete loss of motor control below the level of injury, the
most severe degree of SCI as defined by the American Spinal Injury Association Impairment Scale
(AIS). Clinicians used both ISNCSCI (International Standards for Neurological Classification of
Spinal Cord Injury) and GRASSP (Graded Assessment of Strength Sensibility and Prehension) measures
to establish a pre-transplant baseline for each patient and to assess post-transplant progress.
This first cohort of the Pathway Study was designed to assess the safety, and preliminary signs of
efficacy, of cell administration into the cervical cord and select the dose level for the
40-patient second cohort, a randomized, controlled and single-blinded arm of the trial, which is
already underway.
Based on six-month follow-up, for the first cohort, an overall pattern of motor improvement was
detected in four of the six patients as measured by gains in both strength and function on the
collective ISNCSCI and GRASSP outcomes.
Additional highlights of the six-month interim results include:
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Muscle strength was improved in five of the six patients. |
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Four of the five patients with gains in muscle strength also demonstrated improved
performance on functional tasks assessing dexterity and fine motor skills. |
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Four of the six patients had improvement in the spinal level of injury as defined by the
ISNCSCI assessment; three upgraded one level and one upgraded two levels. |
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Based on a Patient Global Impression of Change (PGIC) assessment, four of the six
patients reported that their condition had improved post-transplant. |
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Changes in muscle strength and function were observed around three months
post-transplant, consistent with the onset of sensory improvements seen in the Companys
Phase I/II thoracic study. |
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No adverse events were attributed to the cells. |
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The timing of the transplants ranged from ten to 23 months post-injury. |
The early analyses of motor improvement from the first cohort of the Pathway Study are consistent
with an evolution of the sensory outcomes seen in StemCells previous thoracic study, said Armin
Curt, MD, the principal investigator at the University of Zurich for the Companys previous Phase
I/II thoracic spinal cord injury study. The emerging data are the first clinical evidence of a
treatment effect improving muscle strength and function following cellular transplant in spinal
cord injuries. These findings are even more compelling given that all the patients are between one
and two years post injury.
We do not expect to see spontaneous recovery in spinal cord injury patients more than a year after
their injury, added StemCells CMO and Vice President, Clinical Research, Stephen Huhn, M.D.,
FACS, FAAP. The improvements in upper extremity muscle strength and function can be seen in
specific tasks such as opening a jar, picking up coins or grasping and turning a key. Gaining the
ability to perform these simple tasks should result in more independence and an improved quality of
life for those impacted by spinal cord injuries. These findings demonstrate the ability of our
HuCNS-SC® cells to improve both muscle strength and motor function, thereby changing the
trajectory of recovery following a spinal cord injury.
These are the results we have been waiting to see in our spinal cord injury program. For the first
time, we have seen improvements in strength and motor function. While preliminary, these results
should come as really exciting news for spinal cord injury patients and their families, commented
StemCells CEO Martin McGlynn. Until now, they have had little hope for a therapy that might
improve the quality of their lives. These data are also very encouraging for the many StemCells
employees and stakeholders who remain steadfast to our mission to address unmet medical needs
through the use of novel cell-based therapeutics which hold the promise of better treatments and
potential cures for a wide range of diseases and disorders of the central nervous system.
StemCells, Inc. would like to thank all of the patients, their families and caregivers who are
participating in this study, along with the clinical investigators who are enabling this
groundbreaking research. It is their courage and leadership that enables scientific advancement and
the potential for exciting new therapies.
Live Webcast to Discuss the 6 Month Interim Results is Scheduled Today at 4:30 PM ET (1:30 PM
PT)
StemCells, Inc. will host a webcast to discuss the interim results from the Phase II clinical
trial of HuCNS-SC cells in spinal cord injury after market close today, November 18, at 4:30 p.m.
Eastern Time (1:30 p.m. Pacific Time).
Live webcast: http://edge.media-server.com/m/p/zmuy6r4y
About the Pathway Spinal Cord Injury Clinical Trial
The Phase II Pathway Study, 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 stem cells (HuCNS-SC cells) into patients with
traumatic injury in the cervical region of the spinal cord. Conducted as a randomized, controlled,
single-blinded study, the trial will measure efficacy 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 enroll approximately 52 subjects and follow the patients for 12
months post-transplant.
Information about the Companys spinal cord injury program can be found on the Companys, Inc.
website at:
http://www.stemcellsinc.com/Clinical-Programs/SCI
Information on the Companys pre-clinical spinal cord injury research, along with an animation on
the science of HuCNS-SC cells for the treatment of spinal cord injuries, can be found at:
http://www.stemcellsinc.com/Science/Pre-Clinical-Studies/About-SCI
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
in which its proprietary HuCNS-SC cells have been transplanted directly into all three components
of the central nervous system: the brain, the spinal cord and the eye. StemCells, Inc. clinicians
and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases
and disorders of the 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 HuCNS-SC platform technology is a highly purified composition of human neural
stem cells (tissue-derived or adult stem cells). Manufactured under cGMP standards, the Companys
HuCNS-SC cells are purified, expanded in culture, cryopreserved, and then stored as banks of cells,
ready to be made into individual patient doses when needed.
About StemCells, Inc.
StemCells, Inc. is currently engaged in clinical development of its HuCNS-SC platform
technology (purified human neural stem cells) as a potential treatment for both neurological and
retinal disorders. Top-line data from the Companys Phase I/II clinical trial in thoracic spinal
cord injury (SCI) showed measurable gains involving multiple sensory modalities and segments,
including the conversion of two of seven patients enrolled in the study with complete injuries to
incomplete injuries, post-transplant. The Companys Pathway Study, a Phase II proof-of-concept
trial in cervical SCI is actively enrolling at twelve sites. The Company has also completed its
Phase I/II clinical trial in geographic atrophy dry age related macular degeneration. Top-line
results from this study show a positive safety profile and favorable preliminary efficacy data. The
Companys Radiant Study, a Phase II multi-center proof-of-concept trial in GA-AMD is now actively
enrolling at three sites. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a
fatal myelination disorder in children, the Company showed preliminary evidence of progressive and
durable donor-derived myelination by MRI.
Further information about StemCells, Inc. 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 the future business operations of StemCells, Inc. (the Company); statements about the
prospect of generating statistically meaningful data from the Pathway Study; statements about the
nature and significance of the treatment effect seen in the Pathway Study; and statements about and
the prospect for continued clinical development of the Companys HuCNS-SC cells in CNS disorders.
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 uncertainties about whether preliminary
data in any Phase I or Phase II clinical study will prove to be reproducible or biologically
meaningful in any future clinical study; risks whether the FDA or other applicable regulatory
agencies, including applicable institutional review boards at one or more clinical trial sites,
will permit the Company to continue clinical testing or conduct future clinical trials;
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; uncertainties regarding whether results in preclinical research in animals will be
indicative of future clinical results in humans; uncertainties regarding the Companys
manufacturing capabilities given its increasing preclinical and clinical commitments; uncertainties
regarding the validity and enforceability of the Companys patents; uncertainties as to whether the
Company will become profitable; 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, 2014 and in
its subsequent reports on Forms 10-Q and 8-K.
CONTACT:
Greg Schiffman, Chief Financial Officer StemCells, Inc.
(510) 456-4128
Lena Evans
Russo Partners
(212) 845-4262
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