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.

23 comments

  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

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