JUN 20, 2014
Comprehensive Ophthalmology, Retina/Vitreous
StemCells, Inc., has reported positive interim results from its phase 1/2 clinical trial of a human neural stem cell platform in dry AMD.
Based on at least six months’ follow-up, the results showed a 65 percent reduction in the rate of geographic atrophy (GA) in the study eye when compared to the expected natural history of the disease, as well as a 70 percent reduction in the rate of GA when compared to the control eye.
The interim results also indicate improvement in contrast sensitivity in four of the seven patients, while contrast sensitivity remained stable in the other three patients.
The study was conducted by administering a single injection of HuCNS-SC, the company’s proprietary stem cell platform, into the space behind the retina in the most affected eye. The interim analysis demonstrates a favorable safety profile for this treatment.
"The interim data are very encouraging from two separate perspectives,” said Stephen Huhn, MD, FACS, FAAP, vice president of CNS clinical research and chief medical officer at StemCells, Inc. “First, the reduction in the rate of geographic atrophy suggests the HuCNS-SC cells are affecting the underlying cause of AMD. Secondly, the data demonstrates there are increases in contrast sensitivity, which is a vital aspect of visual function.
“These results are particularly interesting given that the first cohort of patients had significant visual impairment and baseline GA,” said David Birch, PhD, chief scientific and executive officer of the Retina Foundation of the Southwest in Dallas, one of the five locations where the study is being conducted. “The next cohort of patients will have less impairment and we look forward to learning even more as we analyze data from the patients in the second half of the trial."
The company plans to initiate a randomized, controlled, phase 2 proof-of-concept trial later this year.