Israel’s BrainStorm Initiates Technology Transfer to City of Hope for NurOwn ALS Phase 3 Study

Israel’s BrainStorm Initiates Technology Transfer to City of Hope for NurOwn ALS Phase 3 Study

BrainStorm Cell Therapeutics has begun training the cell manufacturing team at City of Hope’s Center for Biomedicine and Genetics to produce NurOwn adult stem cells for a Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS).

Los Angeles-based City of Hope will be the clinical supplier of NurOwn stem cells for all U.S. medical centers participating in the study.

NurOwn uses a patient’s own mesenchymal stem cells (MSCs), isolates them the patient’s bone marrow, and expands and induces them to differentiate into NurOwn (MSC-NTF) cells. The cells with neuro-protective properties are then transplanted back into the patient. NurOwn spurs production of growth factors that help neurons survive — a critical step in treating neurodegenerative diseases such as ALS.

BrainStorm develops and commercializes NurOwn in partnership with Ramot, the business engagement unit of Israel’s Tel Aviv University.

Following completion of a Phase 2 clinical trial that showed that NurOwn was safe and well tolerated — and able to halt or reverse ALS progression — the U.S. Food and Drug Administration (FDA) gave BrainStorm permission to start a Phase 3 trial. The randomized, double-blind, placebo-controlled multi-dose Phase 3 clinical trial will be conducted at multiple U.S. and Israeli sites, with enrollment of patients starting later this year.

The FDA has accepted some components of the Phase 3 program protocol to support a Biologic License Application for NurOwn.

“City of Hope is one of the world’s pre-eminent cell product manufacturing centers,” Chaim Lebovits, president and CEO of BrainStorm, said in a  news release. “The transfer of our proprietary autologous cell production technology to City of Hope’s production team reflects the rapid progress we are making in preparing for our Phase 3 ALS clinical study and will ensure that we have adequate high-quality cell-production capacity in place when we begin the Phase 3 study.  We welcome them as a clinical partner and appreciate their commitment to the success of this important clinical program.”

Added Joseph Gold, manufacturing director at the Center for Biomedicine and Genetics: “BrainStorm’s NurOwn technology represents an innovative approach to treating ALS. City of Hope is excited to play a role in treating this devastating disease.”

10 comments

  1. Karen says:

    Is there a date that this expected? Do you know if people will be able to elect to do this on their own and pay for it themselves? This has been on Brainstorm website for some time, they were wondering if people would be interested.

  2. Allan Moore says:

    another possible treatment that will be not affordable for ALS people at age 71 that only is having loss of muscle in legs and arms but no home help and no 100.000s of dollars to pay for treatment

  3. Michelle Geoffrion-Vinci says:

    Will this technology transfer delay the start of the phase 3 study? Several sources have indicated that the study was to commence during spring quarter of 2017 (that’s now by my count). Thanks!

  4. Steven says:

    I was diagnosed with ALS st patricks day 2016 I’m in a wheelchair, can’t walk or lift arms with shallow breathing but can still talk and chew swallow is still normal but can choke on water sometime. Will I be back to normal with this therapy?

  5. Talse Filipe, South Africa says:

    I so wish that i could have been part of these trials. South Africa is lost. We simply cant affort this, how can i(us) be part of this exciting trials. Or must we just wait and face our fait? I will give anything just to have a right to try. Please helo me.

  6. don ng says:

    first of all in i simply do not understand why singapore doctor are all like that when i tell them about stem cell they said is not proven what proven are they talking about i think they are less knowledgeable than me i screen at the web site everyday ad i think that so far is proven ok everytime tell them to help em to write to the Ministry of health to release my medisave for my treatment they will said No very very disappointed with them , so what can i do penniless

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