| StemCells provided an update on the ongoing clinical development program of its proprietary HuCNS-SC product candidate (purified human neural stem cells) for neuronal ceroid lipofuscinosis - or NCL -, often referred to as Batten disease. On November 6, representatives of StemCells met with the FDA in Rockville, Maryland to review the results of the company’s recently completed Phase I trial in NCL and to discuss the company’s proposed clinical development plans. The Phase I trial was designed to assess safety, and focused on patients in the late stage of the disease. The discussions with the FDA centered on how the company might construct a second study enrolling patients in less advanced stages of NCL to further expand the safety database and to assess whether earlier intervention might alter the course of the disease. The FDA acknowledged the company’s position that the risk-benefit profile shown by the Phase I data merits further clinical evaluation of HuCNS-SC cells in NCL, and the company obtained constructive feedback and guidance with respect to additional clinical testing of the cells in this fatal disease. The company’s Phase I trial of HuCNS-SC cells for NCL was completed in January. :theflyonthewall.com |
