StemCells, Inc. Issues FDA Update on Proposed Clinical Trial
Related News: Spinal / Nervous / Brain, Stem Cell CompaniesPALO ALTO, Calif.--(BUSINESS WIRE)--March 31, 2005--StemCells, Inc. (NASDAQ: STEM) today announced recent, positive progress towards its goal of initiating Phase I clinical testing of its proprietary neural cell therapy product - HuCNS-SC - in Batten disease.
On February 1, 2005, StemCells announced that the U.S. Food and Drug Administration (FDA) had orally informed it that the proposed trial had been placed on clinical hold. On February 25, 2005, the Company received a letter from the FDA confirming that fact and detailing the Agency's specific comments, questions and requests for additional information.
"In the last 30 days we believe there has been positive and gratifying progress made between StemCells and the FDA," said Martin McGlynn, chief executive officer of StemCells. "After a thorough evaluation of the FDA's questions and concerns we met with the Center for Biologic's Evaluation and Research (CEBR) Clinical Hold Oversight Committee. I would characterize the dialogue from the FDA as informed, supportive and encouraging. Our next step is to prepare an amendment to our original IND filing and re-submit it to the FDA. We are hard at work on this already, and intend to continue to be in active and ongoing dialogue with the FDA throughout the process."
"We are sensitive to and appreciate the care with which the FDA is reviewing our IND for this trial," continued McGlynn. "We are in agreement with the FDA that frequent discussion between the company and the Agency is the best course of action given the ground-breaking nature of our proposed clinical trial."
If approved by the FDA, the proposed study would mark the first-ever FDA-approved clinical trial to use a purified composition of human neural stem cells as the potential therapeutic agent. The Phase I trial is designed to investigate the safety of HuCNS-SC in the treatment of infantile and late-infantile neuronal ceroid lipofuscinosis (NCL), the most severe forms of a group of disorders commonly referred to as Batten disease.
Posted on March 31, 2005 07:25 PM