13:38 , Jun 26, 2018 |  BC Extra  |  Company News

No right-to-try for BrainStorm's ALS therapy

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) will not make its NurOwn therapy available under the U.S. right-to-try law, it announced Tuesday. NurOwn is in a Phase III trial to treat amyotrophic lateral sclerosis. It consists of autologous...
21:00 , Jun 7, 2018 |  BC Extra  |  Company News

BrainStorm considering right to try for ALS therapy

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) is considering offering NurOwn to treat amyotrophic lateral sclerosis under the recently enacted federal right-to-try law, BrainStorm President and CEO Chaim Lebovits told BioCentury. He also discussed the company’s plans on...
00:52 , Dec 16, 2017 |  BioCentury  |  Regulation

Growth medium

FDA’s regenerative medicines framework could level the global regulatory playing field for products like cell and gene therapies. It describes approaches to implementing expedited development and review pathways that make them comparable, and in some...
22:53 , Nov 3, 2017 |  BC Extra  |  Company News

Management tracks: Tissue Regenix, Therapix

Regenerative medical device company Tissue Regenix Group plc (LSE:TRX) named Steve Couldwell CEO. A Tissue Regenix director since 2013, Couldwell was COO of global biosurgery at Sanofi (Euronext:SAN; NYSE:SNY). Cannabinoid company Therapix Biosciences Ltd. (Tel Aviv:TRPX;...
04:51 , Nov 3, 2017 |  BC Week In Review  |  Clinical News

BrainStorm starts Ph III of NurOwn to treat ALS

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) began a Phase III trial of NurOwn (MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS). The double-blind, placebo-controlled, U.S. study will enroll about 200 patients. The primary endpoint is safety,...
21:28 , Jul 28, 2017 |  BC Week In Review  |  Company News

BrainStorm receives $15.9M CIRM grant

The California Institute for Regenerative Medicine (CIRM) awarded BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) $15.9 million to fund a Phase III trial of NurOwn to treat amyotrophic lateral sclerosis. BrainStorm said it is in "advanced stages"...
22:31 , Jul 21, 2017 |  BC Extra  |  Financial News

CIRM grants BrainStorm $15.9M for ALS trial

The California Institute for Regenerative Medicine (CIRM) awarded BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) $15.9 million to fund a Phase III trial of NurOwn to treat amyotrophic lateral sclerosis. BrainStorm said it is in "advanced stages"...
07:00 , Aug 15, 2016 |  BC Week In Review  |  Clinical News

NurOwn: Phase II data

Top-line data from a double-blind, placebo-controlled, U.S. Phase II trial in 48 patients with ALS showed that a single treatment of NurOwn administered by combined intramuscular and intrathecal injection was well tolerated with no treatment-related...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

NurOwn: Completed Phase II enrollment

BrainStorm completed enrollment of 48 patients in the double-blind, placebo-controlled, U.S. Phase II trial evaluating combined intramuscular and intrathecal NurOwn. BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), New York, N.Y.   Product: NurOwn ( MSC-NTF cells) (formerly...
08:00 , Feb 9, 2015 |  BC Week In Review  |  Clinical News

NurOwn: Phase II ongoing>=

BrainStorm said an independent DSMB recommended continuation of a double-blind, placebo-controlled, U.S. Phase II trial evaluating combined intramuscular and intrathecal NurOwn based on a review of safety data. The trial is enrolling about 48 patients...