Worldwide Clinical Trials Picked to Manage Phase 3 Study of NurOwn for ALS

Worldwide Clinical Trials Picked to Manage Phase 3 Study of NurOwn for ALS

Worldwide Clinical Trials was selected as the Clinical Research Organization (CRO) to run a Phase 3 study of the investigational stem-cell therapy NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm Cell Therapeutics, which developed NurOwn, expects the collaboration will provide all of the necessary requirements to pursue the placebo-controlled, multi-dose pivotal Phase 3 trial of its lead drug candidate. The trial will be conducted at multiple sites in the United States and Israel. A kick-off meeting between the companies is expected this month.

“Selecting a CRO is a critical step before initiating patient enrollment into our Phase 3 study of NurOwn in the treatment of ALS,” Chaim Lebovits, the CEO of BrainStorm Cell Therapeutics, said in a press release.

“We see Worldwide as the ideal partner for this important clinical trial — its deep expertise and capabilities in managing pivotal Phase 3 clinical trials in more than 60 countries, particularly in the fields of ALS and neurology, will be tremendous assets to us,” Lebovits added.

NurOwn is based on the collection and expansion of mesenchymal stem cells (MSCs) harvested from patients. These cells have the ability to differentiate into various cell types, and are recognized for their capacity to modulate immune and inflammatory responses with the therapeutic potential for several illnesses.

With its proprietary expansion methods, BrainStorm Cell Therapeutics has developed MSCs that can, in addition to their normal properties, produce growth factors that can support the survival of neurons.

NurOwn has been tested in about 75 ALS patients who were included in three clinical trials, two conducted in Israel (NCT01051882 and NCT01777646), and a Phase 2 trial in the United States (NCT02017912).

Results of the Phase 2 trial in the U.S. included 48 ALS patients and showed that NurOwn was safe and well-tolerated. The treatment also demonstrated the ability to halt or reverse disease progression over a six-month period compared to placebo.

These positive results supported the U.S. Food and Drug Administration’s (FDA) decision to allow the Phase 3 clinical development of NurOwn.

In May, BrainStorm announced that City of Hope’s Center for Biomedicine and Genetics in Los Angeles would be the clinical supplier of NurOwn stem cells to be administrated to all U.S.-based clinical centers participating in the Phase 3 trial.

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  1. Steven says:

    As an ALS patient I’m excited to hear this good news. I’ve been suffering from ALS for two years I have faith I will be back to normal.

  2. Pam Haas says:

    My question is….my husband was in the phase 2 trial at MAYO clinic and did very well…why can’t he be in the phase 3 trial?

    • Alice Melão says:

      Usually, the cohort of patients included in different trials, even for the same drug, are expected to be different to make sure there are no bias in the results. The only exception are extension trials or long term treatment’s evaluations. This is probably why your husband can not participate in this new Phase 3 trial. But in case of doubt you can try to ask the doctor who evaluated your husband in the previous trial.

    • Alice Melão says:

      Dear Margot, the design of the trial is still being developed so I do not know at this point if you met the inclusion criteria.

    • Alice Melão says:

      Dear Marcelo, as I replied to Elaine the locations and treatment centers involved in this Phase 3 trial are not yet stablished.

  3. Irene ottaviani says:

    Would love my husband to be in this clinical trial . Like most ALS victims. He is running out of time😞

  4. James Hermes says:

    I have ALS. I am a Navy veteran. I am 73 years old and in good health other than ALS. I was diagnosed 2013. I have a slow progression. I can still transfer myself. I would love to get in your clinical trial.

  5. Nehal says:

    My sister has ALS 3 years ago , she is in Egypt. How could she participate in this trial.Researches should not be limited on patients in developed countries. Plz.,extend the helping hand for Poor peoples in developing countries. Until the drug reach Egypt and reaches the price we bear, my sister will be in advanced stage.
    Please Help her pleeeeease

  6. Simon Nomoah says:

    Is there a chance for me to participate in this new Phase 3 trial?
    I live with ALS for 3 years now in Sweden

  7. Lucia Ribeiro says:

    Hello! My husband was diagnosed with ALS in dec.2016 and the progression was much faster then the doctors could expect. He is 77 years old and in may 2017 he had a tracheostomy and gastrostomy. He is not able to move any part of his body only his head and eyes. He doesn’t speak only when using a phonation valve (for 2 hour/day maximum). We imported Edaravone from Japan for his first 14 days of treatment and he tolerated well.
    We live in Rio de Janeiro, Brazil and would be easier to import from US. Is that any possibility to do it? Thanks a lot

  8. Stephen Ritchie says:

    I am 32 years old, diagnose 2 weeks ago, living in scotland in the UK. It probably doesn’t matter for selection criteria but in the off chance of scientific empathy, i habe a 22 minth old sone and s wifr who is eight weeks pregnant. I am still mobile, but weakening each week. Each day really. Is there any chance of a phase 3 trial in the UK that I could participate in that would give us some semblance of hope in an otherwise bleak situation? I’m T the bottom of the abyss here

  9. Sampath kumar says:

    My husband is an ala patient.he was diagnosed with ala 2years back. He had his stem cell therapy last year pls let me know the details of this so that I could help him. Pls make a little time to mail it to [email protected]. It would really help me alot.

  10. Mark Harrison says:

    Hi it’s Mark Harrison in Fresno Ca . Was diagnosed with family ALS in March 2017 . It’s November 11 , 2017 . I’m 51 years old and am I would say progressing moderately . I have limb onset as my respitory is still fairly normal and I still have my voice . Walking is harder with use of cane on the outside . I have 24/7 muscle fascinations and cramps throughout my body . I am on the phase 3 trial list and eagerly waiting for my turn . I take multi vitamins b and sleep meds . Anyone with a timeline on when the trial starts would be greatly appreciated .

  11. Liesbeth Verhage says:

    I am 61 years old living in Holland.
    I was diagnosed in february 2017 with ALS can hardly walk and getting worse every day.
    How can I get included in the trials?

  12. Jennifer Hall says:

    I have a friend who will be in phase 3 and scheduled to arrive in 1 -2 weeks. How long will each participant be in Irvine? 6 full months or will they be allowed to return home and then return to CA for assessments? To further clarify she will be coming from TN so in wanting to plan a visit while she is there I just wondering what time frame I had to get out there. Thank you

  13. Lisa says:

    In phase 3 trial at UCI! My bone marrow harvest was last month and my first cell transplant is the day after tomorrow! I’m so excited to be a part of this!!! Now…no placebo please!!! This mama needs to walk again!

  14. Pam Haas says:

    Good luck Lisa! I’m so mad they won’t let my husband in the phase 3 trial cause he was in phase 2 And recived the cells and did great!! You’d think they would want/let those people in!!

    • Lisa says:

      Thanks Pam and I’m sorry your husband can’t get in the trial again! I heard amazing things about Phase 2. I’m praying they fast track this through the FDA. In the meantime, they need to come through with compassionate use!! We all deserve to fight!!!

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