UC Irvine Medical Center to Take Part in Phase 3 NurOwn Trial for ALS

UC Irvine Medical Center to Take Part in Phase 3 NurOwn Trial for ALS

BrainStorm Cell Therapeutics has signed an agreement with the University of California Irvine Medical Center (UCI) to start enrolling patients for an upcoming Phase 3 clinical trial evaluating whether NurOwn can improve functional impairment in amyotrophic lateral sclerosis (ALS) patients.

NurOwn is made of mesenchymal stem cells — a type of cell that can transform into other types of cells. NurOwn’s stem cells are collected from the patients themselves and then transformed into cells that secrete neurotrophic factors, which boost nerve tissue growth.

UCI will join Massachusetts General Hospital in Boston and California Pacific Medical Center in San Francisco, as recently announced by Brainstorm, and become the third U.S. center to enroll patients in the planned Phase 3 NurOwn study.

Brainstorm plans to enroll about 200 patients in the trial. Its primary objective is to see if NurOwn can improve functional impairment using the ALS Functional Rating Scale-Revised, or ALSFRS-R.

Researchers will optimize patient population to include the patient profiles that seemed to respond better to NurOwn in the Phase 2 ALS trial (NCT02017912). The Phase 2 trial assessed the safety and efficacy of NurOwn using ALSFRS-R and slow vital capacity, a measure of breathing capacity.

Based on positive results from the Phase 2 trial, NurOwn was shown to provide meaningful benefits compared to placebo. It was also considered safe and well tolerated by patients.

Dr. Namita Goyal will be UCI’s principal investigator. Goyal is an associate clinical professor of neurology in UCI’s Department of Neurology. She specializes in neuromuscular medicine, neurology, and electrodiagnostic medicine.

“We are privileged to have UCI and Dr. Goyal join our pivotal Phase 3 study of NurOwn,” Chaim Lebovits, president and CEO of BrainStorm, said in a press release. “Adding UCI as an enrolling center with Dr. Goyal as Principal Investigator will make the treatment more accessible to patients in California, and we welcome the opportunity to work with this prestigious institution.”

“NurOwn is a very promising treatment with compelling Phase 2 data in patients with ALS; we look forward to further advancing it in clinical development and confirming the therapeutic benefit with BrainStorm,” Goyal added.

BrainStorm has tested NurOwn in three previous clinical trials involving a total of 75 ALS patients: two in Israel (NCT01051882 and NCT01777646) and one in the U.S. (NCT02017912).

18 comments

  1. Steven says:

    NurOwn is a very promising treatment with compelling Phase 2 data in patients with ALS; we look forward to further advancing it in clinical development and confirming the therapeutic benefit with BrainStorm,” Goyal added. As an ALS patient we need nurown this is big. No one knows how much I would love to improve and function better.

      • Steven says:

        But as an ALS patient I would love to be able to walk, drive an automobile, dress myself, and bath and use the restroom and eventually work again.

    • Steven says:

      Here is a few pro’s Nick the only con I could think of is the harvesting the stem cells from the patients bone marrow that is going to hurt lol but they may put an ALS patient to sleep to do so.

      important point is that all the benefits of NurOwn are coming after a single intrathecal injection. This compares to 64 intravenous injections of edaravone over the 24 week treatment period!
      the most significant benefit with NurOwn came in patients with the rapidly progressive disease.
      there are only two drugs on the market, and both (riluzole and edaravone) show only a modest slowing of disease progression in fairly mild subjects.

  2. Isn’t Mayo going to be named as one of the centers? And what’s taking so long?! This was supposed to happen months ago and they keep saying later this year, later this year! This whole process needs to be rapidly speeded up! The phase 2 showed great results and all of us ALS patients have no time to lose! The FDA may be holding things up and some pressure needs to be applied! As soon as this phase 3 trial shows some success they need to offer this as a treatment based on great need! Even if it didn’t work or there was some harm what’s the difference?! We are dying! And this is the best treatment to date, much better than Radicava!

  3. Harrison Anderson says:

    Having ALS is like holding a ticking time bomb you are trying to defuse. The FDA and the right to try need to work together. Without some new therapy we have no hope.

  4. Patricia pendleton says:

    Dr Goyle at UCI CA is my husbands Doctor we will contact her to see if he can take part in this trial. Is there Any specific criteria that must be met to be part of the trial ??

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