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news.StemCells has closed patient enrollment in its Phase I/II clinical trial for dry age-related macular degeneration (AMD) based on positive interim results.
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The move will help the company to focus its efforts on a follow-on Phase II randomized, controlled proof-of-concept study, later in 2014.
Interim results for the existing AMD trial show a 70% reduction in the rate of geographic atrophy (GA) as compared to the control eye and a 65% reduction in the rate of GA as compared to the expected natural history of the disease after a single dose of the company’s HuCNS-SC human neural stem cells.
Apart from these initial efficacy findings, the Phase I/II trial has also showed a favorable safety profile for HuCNS-SC as a treatment for dry AMD.
The company said that final results from this trial are expected to be released mid-2015.
StemCells chief medical officer and vice president of CNS clinical research Stephen Huhn said the strength of the interim results exceeded the company’s expectations.
"These positive clinical safety and efficacy findings are an important milestone in our goal of developing a first-in-class therapy for dry AMD based on our proprietary HuCNS-SC platform technology," Huhn said.
"We now need to move forward to the next phase of product development and replicate these results in a Phase II study appropriately designed to demonstrate the efficacy of our HuCNS-SC cells as a treatment for dry AMD."