BrainStorm Cell Therapeutics Passes Safety Milestone In Phase 3 Trial Of NurOwn® Therapy for ALS

Source: Mediamodifier, no changes made, CC0 Creative Commons.
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BrainStorm Cell Therapeutics Inc., founded in 2004, based in New York City, is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases.

The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University.

Amyotrophic Lateral Sclerosis (ALS) is also known as motor neuron disease or Lou Gehrig’s disease, which involves the loss of neurons controlling voluntary muscles. Symptoms include stiff muscles, twitching, and progressive weakness due to decreased muscle mass. This causes difficulty in speaking, swallowing and eventually breathing.

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NurOwn® has been administered to approximately 100 patients with Amyotrophic Lateral Sclerosis ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo controlled clinical trial conducted in the US, a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo.

In a new Phase 3 trial for ALS (NCT03280056) the first 31 participants treated with NurOwn® have completed a pre-specified interim analysis of safety outcomes by the independent Data Safety Monitoring Board (DSMB). The DSMB indicated there were no significant safety concerns and recommended that the trial continue, as planned.

“BrainStorm is focused on completing the NurOwn® ALS Phase 3 study and to bringing a much needed treatment option to ALS patients,” … “We welcome the DSMB’s review which confirms the safety profile of NurOwn® following repeat dose intrathecal administration.” – Chaim Lebovits, president and CEO of BrainStorm

“We are very pleased the DSMB has found no safety concerns that would require modification to the NurOwn® ALS Phase 3 protocol. This represents an important clinical advancement for BrainStorm and for NurOwn® as a viable cellular therapy approach for ALS patients.” – Ralph Kern MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm