Brainstorm Gets $16 Million California Grant for Trial of NurOwn, Its Stem Cell Therapy for ALS

Brainstorm Gets $16 Million California Grant for Trial of NurOwn, Its Stem Cell Therapy for ALS

Brainstorm Cell Therapeutics has received a $16 million grant from a state agency known as the California Institute for Regenerative Medicine to develop a Phase 3 clinical trial of its ALS stem-cell therapy NurOwn.

NurOwn is based on mesenchymal stem cells, which can transform themselves into various types of cells. Brainstorm transforms stem cells harvested from patients into cells that secrete neurotrophic factors, which promote nerve tissue growth. The treatment can be injected into muscle or the spinal canal to help nerve cells survive.

Brainstorm plans to enroll about 200 patients in the trial, which will be conducted at six ALS specialty centers in the United States.

The primary objective of the study will be to see if NurOwn can improve patients’ functional impairment. The measuring tool investigators will use is the ALS Functional Rating Scale-Revised, or ALSFRS-R.

Researchers will include in the trial patients who responded well to NurOwn in the Phase 2 ALS trial (NCT02017912).

The Phase 2 study assessed NurOwn’s safety and effectiveness in 48 patients. The effectiveness yardsticks were ALSFRS-R and slow vital capacity, a measure of breathing capacity.

NurOwn provided the patients with meaningful benefits, compared with a placebo, according to the trial results. It also was safe, and patients tolerated it well.

Massachusetts General Hospital in Boston and California Pacific Medical Center in San Francisco will be among the sites to participate in the Phase 3 trial.

The study will begin after the company receives U.S. Food and Drug Administration and Institutional Review Board approval. The board looks at ethical considerations of proposed research.

“We are honored to be awarded this CIRM [state agency] grant, and appreciate the support of CIRM in the development of NurOwn,” Chaim Lebovits, Brainstorm’s president and chief executive officer, said in a press release. “This substantial award provides further support for our technology and clinical program, and recognizes the importance of developing effective treatments for patients afflicted with ALS.”

“CIRM is partnering with Brainstorm to follow up on the company’s promising Phase 2 trial in patients with ALS,” said Maria Millan, the agency’s interim president and chief executive officer. “CIRM’s mission is to accelerate stem cell treatments to patients with unmet medical needs and, in keeping with this mission, our objective is to find a treatment for patients ravaged by this neurologic condition for which there is currently no cure.”

 

16 comments

  1. Colorado 18yr ALS research shows ANY stem cell therapy can only be supportive as a pat on the butt to insure 100% recovery from ALS after the biochemical physics of ALS are corrected. Not before the fact. 16 million dollars to direction and methodology that will not work while Colorado ALS Research was not funded and is in the hole. And can show a recovery from ALS in four to eight months with progression stopped in one month. Colorado ALS research is light years ahead but can’t get past big pharma. And the Veterans Administration is ignoring ALS veterans that are twice as likely to be ALS diagnosed regardless of war served. Radicava is a perfect example of big pharma profiting while saving no one from ALS at a cost of $140,000 a year. This is inexcusable. A flawed system that will allow the horror and death of ALS to go on. ALS cause and recovery is an education in sequential biochemical physics not the failures of medicine. Roughly half of all ALS cases are women who don’t play contact sports. Get in the game people. Enjoy those paychecks to fail. The rest of us would have been fired by now. Colorado ALS Research

  2. Thomas Gavorcik says:

    I am also an ALS patient. I pray every day that something like this will come about to stop and /or reverse my progression.. Eventually I know it will. I just hope I can hang in there until then. I am definitely intrersted in the trial.

  3. Diane says:

    Quite obvious there are life saving treatments out there for ALS victims being withheld ! What the hell is going on!!

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