NEWARK, Calif., Nov. 12, 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, will host a webcast to discuss the six-month interim results from the first cohort in its Phase II PathwayTM Study in cervical spinal cord injury. The Company will also provide a progress update on the second 40-patient cohort which is currently enrolling patients.
The first cohort is an open-label dose escalation arm used to determine the cell dose for the second cohort of the study. The second cohort is a randomized, single-blind study expected to enroll 40 motor complete patients, these are patients with complete loss of motor function below the point of injury. This cohort is statistically powered to demonstrate efficacy of the Company’s proprietary HuCNS-SC® platform technology (purified human neural stem cells) for the treatment of cervical spinal cord injury. The patients in the first and second cohorts undergo all of the same clinical safety and efficacy assessments. All patients in the study will be followed for 12 months post-transplant. Final results from this first cohort will be available Q2 2016, and final results from the study are expected in 2017.
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 on Wednesday, November 18, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
Interested parties are invited to listen to the webcast over the Internet by accessing the Investors section of the Company's website at www.stemcellsinc.com. Webcast participants should allot extra time before the webcast begins to register and, if necessary, download and install audio software.
Event: Clinical update, and top line interim data analysis, of the Pathway, Phase II Spinal Cord Injury Study
Date: Wednesday, November 18, 2015
Time: 4:30 PM ET (1:30 PM PT)
Live webcast: http://edge.media-server.com/m/p/zmuy6r4y
An archived version of the webcast will be available for replay on the Company's website beginning approximately two hours following the conclusion of the live call and continuing for a period of 90 days.
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 Company’s 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-blind 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 Company’s spinal cord injury program can be found on the StemCells, Inc. website at:
http://www.stemcellsinc.com/Clinical-Programs/SCI
Information on the Company’s 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 Company’s 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 Company's 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 Company's 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 Company's 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 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") and the prospect for continued clinical development of the Company's 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 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 preclinical and 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.