International Stem Cell Corporation Announces Positive Interim Clinical Results for Parkinson's Disease Clinical Trial

CARLSBAD, CA--(Marketwired - Nov 13, 2017) - International Stem Cell Corporation (OTCQB: ISCO), a California-based clinical stage biotechnology company developing stem cell-based therapies and biomedical products, announced today the positive six months interim results of the first cohort of Parkinson's disease (PD) patients receiving 30 million ISC-hpNSC cells in the ongoing clinical study. All patients in the first cohort are currently meeting the primary endpoint, which is safety.

"We are already seeing some positive efficacy results six months post-transplantation in this 12-month study. While the relatively small sample size makes it difficult to observe statistically significant differences, the interim efficacy results are very encouraging. The first dose tested was used to determine the safety and tolerability of ISC-hpNSC therapy and is below the optimal therapeutic dose established in our preclinical studies," commented Russell Kern, PhD, ISCO's Executive Vice President and Chief Scientific Officer. "We are anticipating strong results in the second cohort (receiving a higher dose of cells) in which two patients have been treated already. These clinical results build a strong foundation to start phase II clinical trials in PD and traumatic brain injury, which are some of the biggest current unmet medical needs," continued Dr. Kern.

The % OFF-Time, which is the time of day when levodopa medication is not performing optimally and PD 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. One hundred percent of the patients improved their mood six months post-transplantation with an average improvement of 35% in the Beck Depression Inventory and 33% in the Emotional Wellbeing dimension of the Parkinson's Disease Quality of Life Score-39 (PDQ-39). 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. Conducting routine daily activities seemed easier after six months as demonstrated by the average improvements of 22% in Activities of Daily Living and 15% in Mobility dimensions of PDQ-39. The Bodily Discomfort dimension of PDQ-39 also improved an average of 12% after six months. The Unified Parkinson's Disease Rating Scale in the OFF period did not improve six months post-transplantation. Impulsive and compulsive disorders were diminished, as demonstrated by the 53% reduction in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease. No test article related serious adverse events have been reported in the clinical trial. There is no evidence of tumors, cysts, enhanced inflammation or infection. Furthermore, no Human Leukocyte Antigen antibodies against the implanted ISC-hpNSC have been detected.