News: International Stem Cell Corporation Doses First Patient of the Third Cohort in Parkinson's Disease Clinical Trial
7:00 am ET June 11, 2018 (Globe Newswire) Print
International Stem Cell Corporation (OTCQB:ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, announced today that the first patient of the third cohort of the clinical trial for Parkinson's disease was successfully transplanted with 70,000,000 ISC-hpNSC(R).
The operation was performed at the Royal Melbourne Hospital (RMH) in Melbourne, Australia by a team of RMH neurosurgeons. The surgery proceeded with no complications and the patient was discharged soon after.
Prior to the surgery, a Data and Safety Monitoring Board (DSMB) meeting was held in which board members reviewed cumulative safety data of the first and second cohorts and determined that it was safe to proceed to the third cohort.
All four patients from the first cohort have entered the follow-up phase while three patients from the second cohort have completed the six-month evaluation. The study will conclude following the dosing of the last three patients of the third cohort, which ISCO plans to complete in 2018.
Previously, the Company announced interim results of the clinical trial at the American Academy of Neurology annual meeting. The % OFF-Time, which is the time of day when levodopa medication is not performing optimally and Parkinson's disease symptoms return, decreased an average of 24% for the first cohort at six months post-transplantation. The % ON-Time without dyskinesia, which is the time of day when levodopa medication is performing optimally without dyskinesia, increased an average of 19% for the first cohort during the same period. 100% of patients improved or retained the same cognitive abilities with an average improvement of 14% in the Cognitive Impairment dimension of the PDQ-39.
"We are thrilled to provide yet another exciting update regarding the progress of our Parkinson's disease clinical trial," commented ISCO's Executive Vice President and Chief Scientific Officer Russell Kern, PhD. "While the patient received the highest dose of ISC-hpNSC(R) cells, we are confident that the therapy is safe and well-tolerated. Additionally, we continue to see encouraging signs of improvement that are dose-dependent, with patients with higher dosage performing better on average than patients with lower dosage," he continued.
About the clinical study
The Phase I clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC(R), intracranially transplanted into patients with moderate Parkinson's disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30,000,000 to 70,000,000 neural cells. A total of 12 participants with moderate-to-severe Parkinson's disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals to evaluate the safety and biologic activity of ISC-hpNSC(R). A PET scan will be performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC(R) will be evaluated using various neurological assessments such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr and other rating scales. An extension phase of the study will evaluate patients every 6 months for 5 additional years.
About Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement-related. These symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease, and depression as the most common psychiatric symptom. Parkinson's disease is more common in people over the
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