Batten disease is a rare and fatal neuro-degenerative genetic condition affecting infants and children. The proposed phase I trial has been on hold since February 2005, pending a complete response to questions and concerns presented to the company by the FDA.
“In May of this year, we announced that we expected to file our response to the FDA in Q3, and I am pleased to say we have done so,” said Martin McGlynn, president and CEO of StemCells. “Our primary focus has been the preparation of what we believe to be a complete response letter, in the form of an investigational new drug (IND) application amendment, in an effort to provide the information required so that our application can be taken off of clinical hold.”
StemCells announced the filing of its first IND application on January 4, 2005. If approved by the FDA, this would mark the first ever FDA-approved clinical trial to use a purified composition of human neural stem cells as the potential therapeutic agent.