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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June 26, 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.
Earlier today, StemCells, Inc. (the "Company") issued a press release announcing top-line results for its Phase I/II study testing its proprietary HuCNS-SC cells (purified human neural stem cells) as a potential therapy for geographic atrophy, the most advanced form of dry age related macular degeneration (GA-AMD). The Company also announced the initiation of its Radiant Study, a Phase II controlled proof-of-concept study in GA-AMD. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibit 99.1 Press Release, dated June 26, 2015, announcing top-line results for the Company’s Phase I/II study in GA-AMD and initiation of its Radiant Phase II Study in GA-AMD.
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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June 26, 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 June 26, 2015
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StemCells, Inc. Reports Top Line Results for its Phase I/II Study in Dry Age Related Macular
Degeneration
Initiates Phase II Proof-of-Concept Radiant Study in AMD
NEWARK, CA, June 26, 2015 (GLOBE NEWSWIRE) StemCells, Inc. (NASDAQ: STEM), a leading stem
cell company developing novel cell-based therapeutics for treating diseases and disorders of the
central nervous system, announced today that Dr. Stephen Huhn, its Vice President of Clinical
Research and Chief Medical Officer, presented an overview of the Companys clinical translation
efforts to date, including a summary of the safety and preliminary efficacy data from the Companys
Phase I/II study investigating its proprietary HuCNS-SC® cells (purified human neural
stem cells) as a potential therapy for geographic atrophy the most advanced form of dry age related
macular degeneration (AMD). The summary was presented Friday, June 26, at 4:00 p.m. CEST, at the
2015 Annual Meeting of the International Society for Stem Cell Research (ISSCR) being held in
Stockholm, Sweden.
The Companys 15-patient, open-label, Phase I/II trial was designed to evaluate the safety and
preliminary efficacy of sub-retinal HuCNS-SC cell transplantation in geographic atrophy (GA), the
most advanced form of dry AMD. Multiple safety and efficacy assessments were incorporated into the
study, including various assessments of visual function and measurements of disease status by
direct retinal examination. The tests in the study included best-corrected visual acuity (BCVA),
contrast sensitivity (CS), microperimetry for analysis of visual function, optical coherence
tomography (OCT), and fundus autofluorescence (FAF) to measure the extent of the underlying
geographic atrophy.
The safety profile emerging from the Phase I/II study supports the recent initiation of the
Companys Radiant Study, a Phase II controlled proof-of-concept trial. The BCVA and CS measurements
for the majority of the patients in the study either improved or remained stable in the treated
eye. OCT analysis showed increases in central subfield thickness and in macular volume in the
treated eye relative to the untreated eye. The prospective analysis of both cohorts in the study
showed GA growth rates in the study eye that were lower than those seen in the control eye,
consistent with the previously reported interim findings for Cohort I alone. However, to further
investigate the possible effect of the cells on GA and to inform future clinical development, the
Company subsequently engaged a reading center to perform a separate post-hoc assessment. The
separate assessments have revealed greater than anticipated variability in grading of the images.
While the prospective analysis for both Cohorts continues to show a decrease in the rate of GA
progression in the treated eye for the majority of the patients, the post-hoc analysis did not
reveal a similar trend. Further analysis of the collective data is ongoing to determine possible
explanations for these findings.
While this was a small open label study, we are encouraged by the continuing strong safety profile
of the cells and the favorable trends we have observed in the studys best corrected visual acuity,
contrast sensitivity and optical coherence tomography assessments, commented Dr. Huhn. While at
this time we cannot draw strong inferences about the rate of geographic atrophy progression from
this small Phase I study, the Phase II Radiant Study design addresses the known limitations of the
Phase I/II study. For example, the patient inclusion criteria will help ensure a study population
that is more homogenous and more representative of the target population of patients with AMD, with
less advanced disease and therefore more measurable GA.
We are therefore very pleased and excited to take the next important step in clinical development
of the Companys AMD program. The Phase II Radiant Study has been initiated and the trial is
designed to formally compare outcomes between the transplanted and non-transplanted eye in each
patient in order to demonstrate slowing of the progression of the disease. The first active site is
enrolling and we plan to have approximately twenty U.S. sites eventually participating in the
study.
About Age-Related Macular Degeneration
Age-related macular degeneration refers to a loss of photoreceptors (rods and cones) from the
macula, the central part of the retina. AMD is a degenerative retinal disease that typically
strikes adults in their 50s or early 60s and gradually progresses to destroy central
vision. According to the Foundation Fighting Blindness website, an estimated ten million people in
the U.S. either have AMD or are at substantial risk for receiving the diagnosis. Overall, about 85%
of patients with AMD suffer from the dry form of the disease, and the advanced dry form of AMD is
referred to as Geographic Atrophy. There are no therapies currently available to treat the dry form
of the disease.
About the Phase I/II Trial
The Companys Phase I/II trial evaluated the safety and preliminary efficacy of HuCNS-SC cells
as a treatment for dry AMD. The investigation was divided into two sequential cohorts. Subjects
were enrolled into each cohort based on best-corrected visual acuity (BCVA) as determined by the
Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) acuity test. BCVA of less than or
equal to 20/400 in the Study Eye were enrolled in Cohort I. Subjects with BCVA of 20/320 to 20/100
in the Study Eye were enrolled in Cohort II. Cohort I consisted of four subjects who underwent
transplant with 200,000 cells followed by four subjects who underwent transplant with 1 million
cells. Cohort II consisted of 7 subjects who underwent transplant with 1 million cells. The
HuCNS-SC cells were administered by a single injection into the space behind the retina in the most
affected eye. Patients vision was evaluated using both conventional and advanced state-of-the-art
methods of ophthalmological assessment. Evaluations were performed at predetermined intervals over
a one-year period to assess safety and signs of visual benefit. Patients will then be followed in a
separate observational study. The trial enrolled patients at three centers:
Retina Foundation of the Southwest, Dallas, TX; Byers Eye Institute at Stanford, Stanford Hospital
and Clinics; Palo Alto, CA; and New York Eye and Ear Infirmary, New York City, NY.
Information about the Companys Dry Age Related Macular Degeneration program can be found on the
StemCells, Inc. website at:
http://www.stemcellsinc.com/Clinical-Programs/AMD
Additional information about the RadiantTM clinical trial is available at the U.S.
National Institutes of Health website at:
https://clinicaltrials.gov/show/NCT02467634
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 in humans, 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 disorders of
the central nervous system (CNS). 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 2 of 7 patients enrolled in the study with complete injuries
(AIS A) converting to incomplete injuries (AIS B), post-transplant. In addition to the completion
of the Phase I/II thoracic SCI study and the ongoing Pathway study, StemCells, Inc. has completed
enrollment in its Phase I/II clinical trial in geographic atrophy of age-related macular
degeneration (GA-AMD), the most severe form of dry AMD and the leading cause of blindness in the
elderly. Based upon interim results for patients who had completed twelve months of follow-up, the
Company reported reductions in the rate of progression in GA as compared to the untreated eye and
the expected natural history of the disease, although these observations were not confirmed in a
subsequent post hoc analysis. 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
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 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); the timing and
prospects associated with detecting potential clinical benefit from the use of the Companys
HuCNS-SC cells; the ability of HuCNS-SC cells to affect the rate of geographic atrophy; the
prospect for continued clinical development of the Companys HuCNS-SC cells in CNS disorders; the
prospect that the Company can initiate the necessary clinical trial sites and enroll study subjects
in a timely fashion, if at all, in the Radiant and Pathway Phase II Studies; and the likelihood
that early signs of clinical efficacy can be replicated in future clinical studies. 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 with respect to the fact
that additional trials will be required to confirm the safety and demonstrate the efficacy of the
Companys HuCNS-SC cells for the treatment of spinal cord injury, AMD, PMD, or any other condition;
uncertainties about whether data in any Phase I clinical study will prove to be reproducible or
biologically meaningful in any future clinical study; risks whether the FDA or other applicable
regulatory agencies 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 the Companys manufacturing capabilities given its increasing
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 disclosed in Part I, Item 1A in the Companys Annual
Report on Form 10-K for the year ended December 31, 2014 and in its subsequent reports on Form 10-Q
and Form 8-K.
CONTACT:
Greg Schiffman
StemCells, Inc.
Chief Financial Officer
(510) 456-4128
Lena Evans
Russo Partners
(212) 845-4262
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