StemCells, Inc. has announced that based on positive interim results, it has closed enrollment in its Phase I/II clinical trial for dry age-related macular degeneration (AMD) in order to focus its efforts on a follow-on Phase II randomized, controlled proof-of-concept study, later this year.
Interim results for the current AMD trial show a 70 percent reduction in the rate of geographic atrophy (GA) as compared to the control eye and a 65 percent reduction in the rate of GA as compared to the expected natural history of the disease following a single dose of the Company's proprietary HuCNS-SC® human neural stem cells.
In addition to these initial efficacy findings, the Phase I/II trial has also demonstrated a favorable safety profile for HuCNS-SC® as a treatment for dry AMD. Final results from this landmark study are expected to be released mid-2015.
"The strength of the interim results exceeded our expectations," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and chief medical officer, StemCells, Inc. "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. 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."
"There is a large unmet medical need for patients suffering from this disabling disease," continued Dr. Huhn. "I have the utmost respect and gratitude for all of the brave patients, their families and caregivers who have been open to participating in this study."