Positive Six-Month Results, With Gains in Both Strength and Motor Function, for the First Cohort in the Phase II Pathway Study
NEWARK, Calif., Nov. 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:
· Muscle strength was improved in five of the six patients.
· Four of the five patients with gains in muscle strength also demonstrated improved performance on functional tasks assessing dexterity and fine motor skills.
· 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.
· Based on a Patient Global Impression of Change (PGIC) assessment, four of the six patients reported that their condition had improved post-transplant.
· Changes in muscle strength and function were observed around three months post-transplant, consistent with the onset of sensory improvements seen in the Company’s Phase I/II thoracic study.
· No adverse events were attributed to the cells.
· 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 Company’s 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.”
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.
Interested parties are invited to listen to the webcast over the Internet by accessing the Investors section of the Company’s website at http://www.stemcellsinc.com.