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
| Date of Report (Date of Earliest Event Reported): | May 19, 2014 |
StemCells, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
| Delaware | 000-19871 | 94-3078125 |
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_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
| 7707 Gateway Blvd, Suite 140, Newark, California | 94560 | |
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_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
| Registrant’s telephone number, including area code: | 510.456.4000 |
Not Applicable
______________________________________________
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 May 19, 2014, StemCells, Inc. (the "Company") issued a press release announcing the presentation of data from the Company's Phase I/II clinical study of its HuCNS-SC cells (purified human neural stem cells) in patients with spinal cord injury, which show significant gains in sensory function in two additional patients. The data was presented at the Annual Meeting of the American Spinal Injury Association in San Antonio, Texas. A copy of this press release is attached hereto as Exhibit 99.1.
On May 22, 2014, the Company issued a press release announcing the initiation of the final cohort in the Phase I/II clinical study of its HuCNS-SC cells in patients with geographic atrophy of age related macular degeneration. A copy of this press release is attached hereto as Exhibit 99.2.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit 99.1 Press release, dated May 19, 2014, announcing the presentation of an interim update on the Company's clinical study of HuCNS-SC cells in patients with spinal cord injury.
Exhibit 99.2 Press release, dated May 22, 2014, announcing the initiation of the final cohort of the Company's clinical study of HuCNS-SC cells in patients with geographic atrophy of age related macular degeneration.
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.
| StemCells, Inc. | ||||
| May 23, 2014 | By: |
/s/ Kenneth Stratton
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| Name: Kenneth Stratton | ||||
| Title: General Counsel | ||||
Exhibit Index
| Exhibit No. | Description | |
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99.1
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Press Release, dated May 19, 2014 | |
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99.2
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Press Release, dated May 22, 2014 |
StemCells, Inc. Provides Update on its Phase I/II Study in Spinal Cord Injury
Significant Sensory Gains Observed in Additional Patients
NEWARK, CA, May 19, 2014 (GLOBE NEWSWIRE) — StemCells, Inc. (Nasdaq:STEM) announced today that Armin Curt, M.D., study principal investigator, presented an interim update on the Phase I/II trial in spinal cord injury at the Annual Meeting of the American Spinal Injury Association in San Antonio, Texas. Interim analysis of clinical data to date has shown that the significant post-transplant gains in sensory function first reported in two patients have now been observed in two additional patients.
The presentation included the first data on AIS B subjects to be transplanted in the Phase I/II chronic spinal cord injury trial with the HuCNS-SC® cells. In contrast to AIS A patients who have no mobility or sensory perception below the point of injury, AIS B subjects are less severely injured, they are paralyzed but retain sensory perception below the point of injury. Two of the three AIS B patients had significant gains in sensory perception and the third remained stable. The interim results also continue to confirm the favorable safety profile of the cells and the surgical implant procedure.
The presentation included data from a total of five new subjects with a minimum six month follow up. In total, the Company has now reported clinical updates on a total of eight of the twelve patients enrolled in its Phase I/II clinical trial using the Company’s proprietary HuCNS-SC (purified human neural stem cells) platform technology for chronic thoracic spinal cord injury.
“Thoracic spinal cord injury was chosen as the indication in this first trial primarily to demonstrate safety. This patient population represents a form of spinal cord injury that has historically defied responses to experimental therapies and is associated with a very high hurdle to demonstrate any measurable clinical change. Because of the severity associated with thoracic injury, gains in multiple sensory modalities and segments are unexpected, and changes in motor function are even more unlikely,” said Dr. Armin Curt, Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich. “In contrast, the cervical cord, which controls more motor function, may represent a patient population in which motor responses to transplant may be more readily anticipated.”
“We are seeing multi-segmental gains and a return of function in the cord in multiple patients. This indicates something that was not working in the spinal cord, now appears to be working following transplantation. This is even more significant because of the time that has elapsed from the date of injury, which ranges from 4 months to 24 months across the subjects with sensory gains,” said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research at StemCells, Inc. “These results are exciting with respect to the expansion of this trial into patients with cervical injury because even a gain of one to two segments in cervical spinal cord injury patients can allow for additional function in the upper extremities.”
A copy Dr. Armin Curt’s presentation can be found on the StemCells, Inc. website at:
http://www.stemcellsinc.com/Presentations/ASIA—FINAL.pdf
About the StemCells, Inc. Spinal Cord Injury Clinical Trial
The Company’s Phase I/II clinical trial is designed to assess the tolerability, safety and preliminary efficacy of HuCNS-SC cells as a treatment for chronic spinal cord injury. The Company enrolled 12 subjects with thoracic (chest-level) neurological injuries at the T2-T11 level, classified as complete (AIS A) or incomplete (AIS B) according to the American Spinal Injury Association Impairment Scale. Seven of the patients enrolled in the study were classified as AIS A and 5 classified as AIS B.
All twelve patients have been enrolled and transplanted with HuCNS-SC cells. Each of the first three subjects suffered a complete injury prior to enrolling in the study. Twelve months after transplantation of the HuCNS-SC cells, data showed multi-segment gains in sensory function in two of the first three subjects, one of which converted from a complete injury classification to an incomplete injury. The third subject in this cohort remained stable, 12 months after transplantation.
The trial enrolled spinal cord injury patients at three centers: the University of Calgary; the University of Toronto; and at Balgrist University Hospital, University of Zurich, all world-leading medical centers for spinal cord injury and rehabilitation.
All subjects who enrolled in the trial received HuCNS-SC cells through direct transplantation into the spinal cord and underwent temporary treatment with immunosuppressive drugs. Evaluations are being regularly performed 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. Preliminary efficacy is being 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 intervention long term, and each of the subjects will be invited to enroll in a separate four-year observational study after completing the Phase I/II study. In addition, the Company plans to initiate a controlled Phase II efficacy trial in in cervical spinal cord injury in 2014.
Information about the Company’s Spinal Cord Injury program can be found on the StemCells, Inc. website at:
http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm
Additional information about the clinical trial is available at:
http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm
and at the U.S. National Institutes of Health website at:
http://www.clinicaltrials.gov/ct2/show/NCT01321333?lead=StemCells+Inc.&rank=4
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, 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 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; 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: Greg Schiffman
StemCells, Inc.
Chief Financial Officer
(510) 456-4128
Andrea Flynn
Russo Partners
(646) 942-5631
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StemCells, Inc. Advances Clinical Trial in Age-Related Macular Degeneration to
Final Cohort
Phase I/II AMD Trial on Track to Complete Enrollment in June
NEWARK, CA, May 22, 2014 (GLOBE NEWSWIRE) — StemCells, Inc. (Nasdaq:STEM) announced today that it has transplanted the Company’s proprietary HuCNS-SC® (purified human neural stem cells) into the first five patients in the final cohort of its 16-patient Phase I/II trial for geographic atrophy of age related macular degeneration (GA-AMD). Each of the eight patients in this second cohort will receive a dose of 1 million stem cells into the most affected eye.
“We are very pleased with the rate of progress being made towards our goal of completing enrollment in this study by the end of this quarter,” said Stephen Huhn, M.D., FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc. “We look forward to releasing the first interim results from this study next month and are planning to initiate a controlled Phase II proof-of-concept study later this year.”
About Geographic Atrophy of Age-Related Macular Degeneration
An estimated 10 million people in the U.S. either have age-related macular degeneration (AMD) or are at substantial risk for receiving the diagnosis, according to the Foundation Fighting Blindness. AMD is a degenerative retinal disease that typically strikes adults in their 50s or early 60s and gradually progresses to destroy central vision. Age-related macular degeneration refers to a loss of photoreceptors (rods and cones) from the macula, the central part of the retina. Overall, about 85% of patients with AMD suffer from the dry form of the disease, the advanced form of which is referred to as “geographic atrophy.”
About the Trial
The Phase I/II trial evaluates the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The investigation is divided into two sequential cohorts. Subjects are 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. Patients with BCVA of less than or equal to 20/400 in the study eye were enrolled in Cohort I. Patients with less severe BCVA of 20/320 to 20/100 in the study eye are being enrolled in Cohort II. Cohort I consists of four subjects who were each transplanted with 200,000 stem cells, followed by four subjects who have each been transplanted with 1 million cells. Cohort II will consist of eight subjects who will undergo transplant with 1 million cells. The HuCNS-SC cells are administered by a single injection into the space behind the retina in the most affected eye. Patients’ vision is being evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations are being performed at predetermined intervals over a one-year period to assess safety and signs of vision improvement. Patients will be followed for an additional four years in a separate observational study.
The trial is currently enrolling patients at five centers. Patients interested in participating in the study should contact one of these centers directly:
| • | Byers Eye Institute at Stanford, Stanford Hospital and Clinics, Palo Alto, CA – |
(650) 498-4486
| • | New York Eye and Ear Infirmary, New York, NY – (212) 979-4251 |
| • | Retina Foundation of the Southwest, Dallas, Texas – (214) 363-3911 |
| • | Retina Research Institute of Texas, Abilene, TX – (325) 690-4414 |
| • | Retina-Vitreaous Associates Medical Group, Los Angeles, California – (310) 289-2478 ext 1243 |
More information about the StemCells Dry Age Related Macular Degeneration program can be found on the Company website at:
http://www.stemcellsinc.com/Therapeutic-Programs/AMD-and-Retinal-Disorders.htm
Additional information about the clinical trial is available at:
http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm
and at the U.S. National Institutes of Health website at:
http://www.clinicaltrials.gov/ct2/show/NCT01632527?term=stemcells+inc+amd&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 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 Company’s preclinical research established that HuCNS-SC cells can be directly transplanted in the central nervous system (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 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 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. 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 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 the prospect of the Company’s HuCNS-SC cells to preserve vision; the prospect and timing of patient enrollment in the Company’s clinical trial in dry AMD; 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 the FDA or other applicable regulatory agencies or review boards will permit the Company to continue clinical testing in AMD; uncertainties regarding the timing and duration of any clinical trials; 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; 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, 2013, and in its subsequent reports on Forms 10-Q and 8-K.
CONTACT: Greg Schiffman
StemCells, Inc.
Chief Financial Officer
(510) 456-4128
Andrea Flynn
Russo Partners
(646) 942-5631
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