BrainStorm Cell Therapeutics, Inc.
| File:Brainstorm logo.png | |
| Public | |
| Traded as | NASDAQ: BCLI |
| ISIN | 🆔 |
| Industry | Biotechnology |
| Founded 📆 | |
| Founder 👔 | |
| Headquarters 🏙️ | , New York, New York, USA |
Area served 🗺️ | |
Key people |
|
| Products 📟 | Technology platform: NurOwn |
| Members | |
Number of employees |  35 (as of January 1, 2019) |
| 🌐 Website | www |
| 📇 Address | |
| 📞 telephone | |
Brainstorm Cell Therapeutics Inc. is a clinical-stage biotechnology company that develops Autotransplantation cellular therapies for Amyotrophic Lateral Sclerosis (“ALS”, also known as Lou Gehrig’s disease). [1][2][3][4]
It holds the rights to clinical development and commercialization of this platform through a worldwide licensing agreement. [1] [5] The company's Israeli subsidiary, holds commercial rights through a licensing agreement with Ramot, a Tel Aviv University technology transfer company. [1] [2]
Technology[edit]
The treatment uses the patient’s own stem cells extracted from a sample of their bone marrow. They’re multiplied and matured to make them behave more like brain cells, afterwards injected back into the patient where the cells help repair the brain and spinal cord. [6]
According to the Jerusalem Post: "During the treatment process, doctors extract cells from the bone marrow of from patients with ALS, and the cells are multiplied and matured, then prepared for injection back into the patient. During the maturation process, the cells from the bone marrow are manipulated into behaving like brain cells, in that they produce materials that are the building blocks of the brain. When these modified cells are put back in patients, the building blocks circulate in the spinal fluid and help repair the damaged brain. Since the cells are taken directly from the patient, that avoids the need for patients to be immunosuppressed so their bodies don’t attack a foreign substance." [2]
History[edit]
Brainstorm was founded in 2004 [4] based on technology developed in the Michael J. Fox Foundation for Parkinson’s Research at Tel Aviv University. [7] [5] [8]
In December 2013, Brainstorm submitted an Investigational New Drug application to the FDA. In April 2014, the company launched a randomized, double-blind, placebo controlled multi-center U.S. Phase 2 trial to test the platform on ALS patients. [1] [9]
In 2014 the NurOwn platform (autologous MSC-NTF cells) for treatment of ALS was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). It was also granted Orphan Drug status by the FDA [10] and the European Medicines Agency (EMA). [1] BrainStorm's ongoing Phase 3 pivotal trial in ALS is studying, repeat-administration of autologous MSC-NTF cells at six sites in the U.S.. This trial is supported by a grant from the California Institute for Regenerative Medicine (CIRM). [1] [11][12]
In January 2016, two completed studies were published in the Journal of the American Medical Association's Neurology journal. [1] [13] The results of these studies showed that the NurOwn platform can slow disease progression in ALS. [14][15] [9] [8]
In October 2017, the first patients were enrolled in a Phase 3 clinical trial for the treatment of ALS. [16][17] [2] [18]
In August 2018, interim analysis of safety outcomes on 31 patients treated with autologous MSC-NTF cells using repeat-administration found no significant safety concerns. It was recommended that the trial continue as planned without protocol modifications. [1]
In December 2018, BrainStorm announced plans for a Phase 2 study of autologous MSC-NTF cells in Progressive MS. [19] The trial is scheduled for early 2019. [1]
In early 2019, BrainStorm also received FDA approval for a Phase 2 trial in Progressive Multiple Sclerosis. [1] [20]
References[edit]
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 BrainStorm Cell Therapeutics site Form 10-K.
- ↑ 2.0 2.1 2.2 2.3 Max Schindler. Israeli-developed ALS treatment reversing motor decline breakthrough. Jerusalem Post. October 17, 2017.
- ↑ Reut Shpigelman. Brainstorm reported about success in phase II clinical trial. Calcalist. July 18, 2016.
- ↑ 4.0 4.1 Tomer Korenfeld. Optimism in brainstorm. Calcalist. October 11, 2008.
- ↑ 5.0 5.1 Roberta Neiger. Israeli therapy uses adult stem cells to treat Parkinson’s Disease. Israel 21c. March 27, 2006.
- ↑ Sadan O, Shemesh N, Barzilay R, Bahat-Stromza M, Melamed E, Cohen Y, Offen Stem Cells. 2008 Oct;26(10):2542-51. doi: 10.1634/stemcells.2008-0240. Epub 2008 Jul 17. Stem cell-based. Sadan O, Shemesh N, Cohen Y, Melamed E, Offen Isr Med Assoc J. 2009 Apr;11(4):201-4. Stem.
- ↑ Revolutionary Stem-Cell ALS Treatment Begins Advanced Trials. Tel Aviv University site. August 27, 2014.
- ↑ 8.0 8.1 BrainStorm Wins $15.9M CIRM Grant for Phase III Trial of ALS Cell Therapy. GEN: Genetic Engineering and Biotechnology News. July 21, 2017.
- ↑ 9.0 9.1 Daniela Semedo. NurOwn Phase 2 Clinical Trial Results Promising, BrainStorm Cell Reports. Als News Today. December 15, 2016.
- ↑ Brainstorm Cell Therapeutics raises NIS 13m. Globes. February 28, 2011.
- ↑ NCT03280056. United States National Library of Medicine.
- ↑ Stem cell co Brainstorm awarded $16m ALS grant: The California Institute for Regenerative Medicine (CIRM) will support a Phase III study for the treatment of amyotrophic lateral sclerosis (ALS). Stem cell co Brainstorm awarded $16m ALS grant. Globes. July 24, 2017.
- ↑ Shimon Cohen. New hope to ALS patients. Arutz Sheva. January 24, 2016.
- ↑ Panayiota Petrou, Yael Gothelf, Zohar Argov, et al. Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis Results of Phase 1/2 and 2a Clinical Trials. JAMA Neurology. 2016;73(3):337-344. Published Online: January 11, 2016.
- ↑ Denise Dador. Hope for ALS treatment after groundbreaking study results revealed. American Broadcasting Company. January 12, 2016.
- ↑ Carolina Hernriques. BrainStorm Enrolls First Patients in Phase 3 Trial Evaluating NurOwn in ALS. ALS News Today. October 17, 2017.
- ↑ BrainStorm enrolls first patients in advanced ALS stem cell trial. October 16, 2017.
- ↑ Abigail Klein Leichman. ALS treatment to begin Phase 3 clinical trials in US. Israel21c. July 31, 2017.
- ↑ Alberto Molano. FDA Gives Green Light to Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Patients. ALS News Today. December 19, 2018.
- ↑ NCT03799718. United States National Library of Medicine.
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