StemCells: Patient Died in Phase I Trial
biz.yahoo.com
Friday January 18, 10:52 am ET
StemCells Reports Patient Death in Early-Stage Trial of Experimental Stem-Cell Treatment
PALO ALTO, Calif. (AP) -- StemCells Inc., a clinical-stage biotechnology company, reported Friday that a patient transplanted with the company's experimental stem-cell product in early-stage clinical trials has died.
The stock fell to a four-year low following the news release.
The Phase I clinical trial of experimental stem-cell product HuCNS-SC was designed to evaluate the safety and preliminary effectiveness of HuCNS-SC cells as a potential treatment for neuronal ceroid lipofuscinosis.
NCL, often called Batten disease, is a rare and fatal neurodegenerative condition afflicting infants and children. Children with NCL suffer seizures, progressive loss of motor skills, sight and mental capacity, eventually becoming blind, bedridden and unable to communicate.
A 9-year-old female patient transplanted with HuCNS-SC cells in January 2007 was due to return this month to the trial site for her 12-month follow-up. However, she was hospitalized nearly two weeks ago, suffering from an apparent viral infection, seizures and respiratory distress, and died earlier this week.
Based on the information available, StemCells said the study's principal investigators, the independent Data Safety Monitoring Committee and the company's medical experts think the death was most likely due to the natural progression of the disease and not related to the HuCNS-SC cells or the transplantation procedure.
StemCells said it is continuing to investigate the death and has been in contact with the U.S. Food and Drug Administration since becoming aware of the patient's condition. The company expects to provide more updates about the trial.
"Our research team was profoundly moved by the loss of one of our patients in the trial. Unfortunately, those of us involved in this trial have seen the devastating and deadly affects of NCL, a fatal degenerative disease, so her death was not unexpected," Dr. Robert D. Steiner, who is a co-principal investigator in the trial, said in a statement.
Shares of Palo Alto, Calif.-based StemCells fell 6 cents, or 4.7 percent, to $1.8, having dropped to $1.16 earlier in the day. The stock last fell to that level on Aug. 8, 2003. Previously, the stock had ranged between $1.21 and $3.20 over the past 52 weeks. |
