Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it’s preparing for a phase III trial of its NurOwn stem cell treatment, after meeting with the FDA about a biologic license application. The company is developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases, such as ALS.
Hackensack, N.J.-based Brainstorm is planning a randomized, double-blind, multi-dose phase III trial at multiple sites across the U.S. and in Israel. The trial is slated to enroll patients in the 2nd quarter of next year.
“We are very pleased with the outcome of the End-of-Phase II meeting with the FDA, and we look forward to initiating our Phase III clinical trial for NurOwn in ALS,” president & CEO Chaim Lebovits said in prepared remarks. “Together with our clinical investigators in the U.S. and Israel, we have worked diligently with the FDA to advance NurOwn through to late-stage development. Building off NurOwn’s safety and clinical efficacy observed to date, we are developing a phase III program that, if successful, will position us to bring to the market an innovative, disease modifying treatment for patients suffering from ALS.”
The company also said it plans to submit a hospital exemption application in Israel, in the hopes of partnering with a medical center and treating patients with NurOwn for a fee.
“Our planned application for Hospital Exemption is our first step toward providing ALS patients with access to NurOwn,” said Mr. Lebovits. “Our decision to proceed with this application is based on a strong interest voiced by ALS patients via a questionnaire. We foresee possible treatments under this pathway as early as the second half of 2017.”