Bring NurOwn to Canada
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Encourage BrainStorm Cell Therapeutics to apply to Health Canada to make their therapy, NurOwn, available for Canadian ALS patients.
Currently there are only two Health Canada approved therapies, Rilutek and Edaravone. Rilutek has been shown to provide a short survival benefit of approximately 2-3 months(1), while Edaravone has been shown to slow progression and prolong the survival rate from a median of 32.5 months to 61.0 months(2). Although these medications slow the disease progression in most ALS patients, it does not stop the progression.
The use of stem cells for the treatment of ALS has been gaining significant attention as of late, with several clinical trials using adipose-derived mesenchymal stem cells (AD-MSCs), bone marrow-derived MSCs (BM-MSC), neural progenitor cells (NPC), peripheral blood stem cells (PBSC), and olfactory ensheathing cells(OEC)(3,4). The most researched stem cell treatment for ALS involves BM-MSC, with at least 19 clinical trials performed to date(3,4).
The safety of BM-MSC administration has been demonstrated throughout the 19 clinical trials conducted so far, with the most common adverse reactions occurring due to intrathecally-administered BM-MSC is headache and fever(3,4). A BM-MSC phase III clinical trial (NCT03280056) occurring in the USA has recently passed its second pre-specified interim analysis by an independent Data Safety Monitoring Board which reviewed 106 patients repeatedly treated with BM-MSC during the trial(5).
Clinical trials involving BM-MSC show efficacy in slowing disease progression post-treatment(3,4). Results from a NurOwn (BM-MSC) phase II clinical trial, presented as a conference call summary(6), show 74 % of treated patientsstabilized with no decline in function at 2 weeks post-treatment compared to controls. The disease stabilization was still observed in 29 % of treated patients 12 weeks post-treatment(5). No other treatment investigated to date has been able to stabilize disease progression in ALS patients.
The NurOwn product has recently been granted orphan drug status by the FDA and the European Medicines Agency. The company which manufactures NurOwn, BrainStorm, applied for approval to distribute NurOwn in Canada in 2017(7). However, this application process was abandoned because Brainstorm didn’t see it as economically profitable avenue for them. ALS has been specifically identified by Health Canada as a serious condition with unmet clinical needs which should qualify for a special regulatory pathway, empowering people with ALS to finally have a chance to fight their disease with a ground-breaking therapy.
Below is a link to a talk, given by the wife of a fire fighter in California, who is fighting ALS as well. The video details some of the success ALS patients have had reversing and slowing down the disease progression:
Another link below the highlights the results of the clinical trials run with NurOwn to date:
1. Dharmadasa, Thanuja et al. “Riluzole, disease stage and survival in ALS.” The Lancet vol. 17 385 – 386. 01 May. 2018, Doi:10.1016/S1474-4422(18)30091-7
2. Okada, Masamitsu et al. “Long-term effects of edaravone on survival of patients with amyotrophic lateral sclerosis.” eNeurologicalSci vol. 11 11-14. 17 May. 2018, Doi:10.1016/j.ensci.2018.05.001
3. Goutman, Stephen et al. “Stem cell treatments for amyotrophic lateral sclerosis: a critical overview of early phase trials.” Expert Opin. Investig. Drugs vol. 28 525 – 543. 2019, Doi:10.1080/13543784.2019.1627324
4. Saeed, Shahbeigi et al. “A comprehensive review on the application of mesenchymal stem cell in the treatment of ALS patients.” J Neurol Neurophysiol vol. 9. 2018,Doi:10.4172/2155-9562.1000471
5. NurOwn® Data Safety Monitoring Board recommends ALS phase 3 clinical trial continue. October, 2019.
6. BrainStorm announces positive top line results from the U.S. Phase 2 Study of NurOwn® in patients with amyotrophic lateral sclerosis (ALS). July, 2016.
7. BrainStorm seeking approval to distribute NurOwn® in Canada. February, 2017.
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