Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Planned for US, BrainStorm Announces

Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Planned for US, BrainStorm Announces

BrainStorm Cell Therapeutics is planning to launch a Phase 2 clinical trial in the United States to evaluate the safety and activity of its lead cell therapy candidate, NurOwn, in people with progressive multiple sclerosis (MS).

The company announced that has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting to start the trial. A separate Phase 3 study of NurOwn in treating amyotrophic lateral sclerosis (ALS) patients is underway and enrolling.

“We plan to quickly initiate the Phase 2 clinical study of NurOwn in progressive MS to address the significant unmet need for MS patients,” Ralph Kern, MD, chief operating officer and chief medical officer of BrainStorm, said in a press release.

NurOwn is an autologous (self) stem cell therapy that takes the patient’s own mesenchymal stem cells (MSCs), modifies them and then returns them to the patient to promote nerve cell-supporting mechanisms.

These stem cells are engineered to produce signaling molecules that regulate the activity of surrounding cells, as well as to secrete neurotrophic factors (NTF) that support the growth, survival, and differentiation of nerve cells. These features support expectations that MSCs could be potential regulators of neurodegeneration, while protecting neurons from damage.

Submitting an IND is an “important step toward the development of NurOwn in progressive MS,” said Chaim Lebovits, president and CEO of BrainStorm, and “confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease.”

The company, Kern added, has already “demonstrated [the] safety and efficacy experience of NurOwn in our amyotrophic lateral sclerosis (ALS) clinical program.”

Results from a Phase 2 trial (NCT02017912) showed that NurOwn could significantly slow functional decline compared to placebo in patients with early stage ALS. Treatment also showed immunomodulatory and neuroprotective effects via regulation of small RNA molecules in the cerebral spinal fluid.

BrainStorm is currently evaluating NurOwn’s safety and efficacy in about 200 adults with ALS in a Phase 3 trial (NCT03280056), now enrolling eligible patients at sites in the U.S. and Canada.

29 comments

  1. My wife of 51 years has progressive M.S. She has no movement in her limbs and has trouble speaking and if there is any possibility to help her please let us know. We are unsure as which way to turn at this time and we are looking for anything that will help. I believe she would be in favor of trying out a new drug, etc…Thank you.

    • Alice Melão says:

      Dear Stephanie,
      The trial has yet to be approved by the FDA so it can be launched. We at Multiple Sclerosis Today are going to follow the advances made on this matter and will release furhter information when it becomes available. But you can also find additional information on the trial when released at https://clinicaltrials.gov

      • Rhonda Danielson says:

        Alice,

        Please! Updates on this trial would be greatly appreciated. There are so few of us with PPMS as compared to RRMS and we get so little of the research pie that any news on a possible treatment or new DMT gives us hope.

  2. Michael A. Cavallo says:

    I’m 61 years old and, after dealing with PPMS for over 40 years, became totally disabled in December of 2017. I can no longer transfer and have lost much of my independence. I would be very eager to try a stem cell treatment. Is there a possibility that it would restore my lost functionalities?

  3. Steve Slobodzian says:

    I would be very interested in participating in a trial in the US for NurOwn. I am interested in helping researchers gain information to cure this disease. I have participated in research for MS related to brain MRI, diet, memory and muscle reflex by University of Kansas. I was also on the Patient Advisory Board for Genetech For Ocrevus before it`s approval by FDA for market roll out. I would love to help your research.

    • Llinda Wisniewski says:

      I have progressive Ms diagnosed in 1991 still able to walk with a cane. Very interested in enrolling in a study using stem cells. Thanks Linda

    • Cathy Olson says:

      I have had multiple sclerosis for 20 years, it has advanced to progressive stage. I would like to get more information about how to be in a clinical trial.

  4. Llinda Wisniewski says:

    I was diagnosed with progressive MS in 1991. Still able to walk using a cane. I am 64 years old. I am not taking any medications for my disease at this time. I am very interested in participating in this study. Thanks Linda

    • Lorri Chester says:

      I was diagnosed with ms in mid 80’s. I am now 60. Still walking (barely). I am very interested in participating in this study. Thanks

  5. Celine says:

    I would be very interested in taking part in the trial. I have MS since 2001 my edds is currently 6.

    Hope to hear from you
    Celine

    • Sandi Thill says:

      Please consider my sister Cathy Olson above. She and her husband Jon are my heroes with how they have handled her having ms and raising a family and a business. Throughout it all they have remained very optimistic that someday there would be some good news. They deserve to have that chance. Thank you very much for the consideration.

  6. sachin says:

    I am not sure regarding the need of doing phase 2 again when it has already been conducted by Prof. karussis at Hadassah involving 48 patients. It’s a bit disappointing that rather than moving forward Brainstorm has taken a step back. This is only going to delay the licensing of an effective treatment.

    • J. Gerard says:

      Professor Karussis of Hadessah did recently complete a phase 2b clinical trial for ms, but it was done using cells that were not minipulated. The ALS trial he conducted concurrently used Nurown cells. The MS trial did not.

  7. CHRISTINA AIVAZOGLOU says:

    WELL EVERYONE WITH PPMS WANTS TO BE IN THIS STUDY BUT ONLY A SELECTIVE FEW WILL ACTUALLY BE INVOLVED. SO IN THE MEANTIME, EAT RIGHT, TAKE YOUR VITAMINS, DO YOGA AND PT.

  8. Sandra Browman says:

    I am 55 years old and have Spms. Could I participate in this trial. I’m not taking any meds. Thank you for your consideration.

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