BrainStorm initiates NurOwn Phase IIa dose-escalating trial in ALS
Published on February 5, 2013 at 12:09 AM
BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the first patient began treatment in the Company's Phase IIa dose-escalating clinical trial for ALS. The trial, which will evaluate the safety and preliminary efficacy of BrainStorm's NurOwn stem cell therapy candidate, is being conducted at the Hadassah Medical Center in Jerusalem.
In the Phase IIa trial, three groups of four patients will receive combined intramuscular and intrathecal administration of NurOwn cells, in increasing doses. The first cohort of four patients is expected to complete treatment by the end of April 2013. The trial participants will be monitored for three to six months following transplantation.
"We are excited to be treating the first patient in this trial, which will build on the excellent safety profile and encouraging positive results from our Phase I/II study," commented Alon Natanson, BrainStorm's CEO.
"This trial will provide valuable data not only on the safety of NurOwn in ALS patients, but also on the ability of different dosing levels to provide clinical benefit," added Prof. Dani Offen, the Company's Chief Scientific Advisor.
Israel's Ministry of Health recently approved BrainStorm's acceleration to a Phase IIa trial following the positive safety evaluation of the first 12 patients in the company's recent Phase I/II trial at Hadassah.
BrainStorm Cell Therapeutics, Inc.