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International Stem Cell Corporation: Trial
This company seems to be having some success with stem cell xplants.
Home - ISCO CARLSBAD, Calif., Nov. 05, 2018 (GLOBE NEWSWIRE) -- via NetworkWire - 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 positive 12-month results of the first cohort and six-month interim results of the second cohort of its currently-ongoing, single-arm, open-label phase 1 clinical study (NCT02452723) evaluating the safety and tolerability of its lead candidate, ISC-hpNSC®, a cellular therapeutic consisting of human parthenogenetic neural stem cells, for the treatment of Parkinson's disease (PD). Six of the 12 patients in the clinical trial of have now completed one year of follow-up observations and one patient in the low dose cohort has now been followed for 2 years. There have been no safety signals or serious adverse effects seen to date as related to the transplanted ISC-hpNSC® cells. "We are excited about our clinical study progress and results. Patients followed for one year after cell transplantation have reported improvements in a Parkinson's specific quality of life measure when compared to baseline evaluations. In this context, the results are encouraging that the procedure of transplantation may be well tolerated," commented ISCO's Executive Vice President and Chief Scientific Officer Russell Kern, PhD. The evaluation is based on more than 12 months of safety data from the first cohort (low dose), and 6 months of data from the second cohort (mid dose). Each cohort is comprised of 4 patients. Dosing of patients in Cohort 3, which is receiving the highest dose, is ongoing. The Melbourne-based Data Safety Monitoring Board (DSMB) has overview responsibilities for evaluating adverse event data from the study and has determined that the favorable safety profile of ISC-hpNSC justified proceeding from Cohort 1 to Cohort 2 and Cohort 3. In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a dose-pendent response. 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 and 49% for the second cohort at six months post-transplantation. The same was true for % ON-Time without dyskinesia, which is the time of day when levodopa medication is performing optimally without dyskinesia. The % ON-Time increased an average of 19% for the first cohort and 33% for the second cohort during the same period. The quality of life of the patients as measured by the Parkinson's Disease Quality of Life Score-39 (PDQ-39) Summary Index, improved 15% for the first cohort and 47% for the second cohort at six months post-transplantation. These results should take into account that this Phase 1 safety study (due to its size), lacks the statistical power to generate efficacy conclusions. In addition, there was no placebo control group. Proper comparisons against a control group will be performed in the Phase 2 clinical trial that we are currently planning. |
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