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Home » Brainstorm Cell Therapeutics

FDA Accepts BrainStorm’s NurOwn® IND Application for Progressive Multiple Sclerosis

December 17, 2018 By Cade Hildreth (CEO) Leave a Comment

Brainstorm NurOwn

U.S. Phase 2 Study to Begin in First Quarter of 2019

NEW YORK, Dec. 17, 2018 — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to initiate a Phase 2 clinical trial of NurOwn® for the treatment of progressive multiple sclerosis (MS).

There are currently no FDA approved autologous cellular therapies addressing MS or other neurological diseases. While treatment options for patients with MS exist, there remains a significant unmet need in progressive MS. There is currently no FDA approved therapy that addresses more than one progressive form of MS.

[Read more…]

Filed Under: MSCs Tagged With: Brainstorm Cell Therapeutics, multiple sclerosis

BrainStorm Cell Therapeutics Announces Submission of IND for NurOwn® in Progressive Multiple Sclerosis

November 19, 2018 By Cade Hildreth (CEO) Leave a Comment

Brainstorm

NEW YORK, Nov. 19, 2018 — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 study of NurOwn® in patients with progressive multiple sclerosis (MS).

“This important step toward the development of NurOwn® in progressive MS confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease,” said Chaim Lebovits, president and CEO of BrainStorm. “This builds upon the important progress made in advancing NurOwn® in the ongoing pivotal study in ALS.” [Read more…]

Filed Under: Press Releases, Stem Cells Tagged With: Brainstorm Cell Therapeutics, multiple sclerosis

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