Exciting Milestone in Regenerative Medicine! The FDA approved #Ryoncil, the first mesenchymal stromal cell (MSC) therapy. This landmark achievement represents a significant step forward for regenerative medicine and underscores the FDA's progressive approach to supporting cell-based therapies. All of us Brainstorm Cell Therapeutics, send congratulations to Mesoblast Limited and the FDA on this groundbreaking approval. The remarks from Dr. Peter Marks and Dr. Nicole Verdun emphasize the FDA's unwavering commitment to fostering innovation and addressing unmet medical needs. This approval sets a promising precedent in the regulatory landscape for #MSC-based therapies, opening doors for transformative treatments for conditions such as ALS. The approval validates the potential of MSC therapies and strengthens our resolve to bring safe and effective treatments to people with ALS. At BrainStorm, we are inspired by this milestone as we advance the development of our own MSC-NTF therapy for ALS. This FDA decision reinforces the potential of MSC-based therapies and strengthens our resolve to bring safe and effective treatments to those living with #ALS. We are proud to be part of this exciting era in regenerative medicine and remain steadfast in our mission to contribute to a future where ALS and other devastating diseases are no longer life-limiting. https://lnkd.in/eH63UdNn #RegenerativeMedicine #CellTherapy #ALS #Innovation
Brainstorm Cell Therapeutics
Biotechnology Research
Kiryat Aryeh, Petach Tikva 6,124 followers
About us
BrainStorm Cell Therapeutics Inc. (NASDAQ) develops autologous stem cell therapies for neurodegenerative disorders such as ALS, MS, and Parkinson’s disease. These diseases have limited treatment options and represent unmet medical needs. NurOwn® is BrainStorm’s proprietary process for differentiating autologous mesenchymal stem cells (MSC) into neurotrophic factor (NTF)-secreting cells, transplanted at or near the affected tissue site. Our technology converts MSCs into a living drug delivery system for NTFs. We have proof-of-concept in various animal models of neurodegenerative diseases, including Parkinson's, Huntington's, ALS, MS, and peripheral nerve injury. We have completed two single-arm clinical trials in ALS patients in Israel, demonstrating good safety and tolerability profiles and strong efficacy signals. We also finalized a Phase 3 randomized, double-blind, placebo-controlled clinical trial at multiple US sites, supported by a $16 million USD grant from the California Institute for Regenerative Medicine (CIRM) and another grant from the ALS Association. Currently, we are planning a Phase 3b clinical trial of NurOwn® in ALS under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). For more information, visit www.brainstorm-cell.com
- Website
-
http://www.brainstorm-cell.com
External link for Brainstorm Cell Therapeutics
- Industry
- Biotechnology Research
- Company size
- 11-50 employees
- Headquarters
- Kiryat Aryeh, Petach Tikva
- Type
- Public Company
- Founded
- 2004
- Specialties
- stem cell therapy, drug development, neurodegenerative diseases, and ALS
Locations
-
Primary
12 Bazel Street
POB 10019
Kiryat Aryeh, Petach Tikva 49001, IL
-
3 University Plaza Drive
Suite 320
Hackensack, NJ 07601, US
Employees at Brainstorm Cell Therapeutics
-
Haro Hartounian, Ph.D.
CEO | Board Director | C-suite | Biotech Innovator and Entrepreneur | Founder | Life Science l Biotechnology | Cell and Gene Therapy | CDMO |…
-
Antal Pearl-Lendner
General Counsel and VP
-
Mary Kay Turner
Public Affairs, Advocacy, Government Affairs, Communications Executive
-
merav bahat
Business Development and Project Manager at
Updates
-
Please join us for a KOL Webinar entitled: Current Developments in the Treatment of Amyotrophic Lateral Sclerosis (ALS) When: December 11, 2024 at 10 AM EST. The webinar will feature Dr. Terry Heiman-Patterson, a KOL from the Lewis Katz School of Medicine at Temple University, who will discuss the current treatment landscape and advances for patients with amyotrophic lateral sclerosis (ALS). Dr. Heiman-Patterson will be joined by BrainStorm's management team, who will share updates on the company's planned Phase 3b registrational clinical trial, NurOwn® (autologous MSC-NTF cells), and future development plans. Successful completion and outcome of the randomized portion (Part A) of the Phase 3b trial is expected to support a Biologic License Application (BLA) for NurOwn. A live Q&A session will follow the formal presentations. https://bit.ly/4fZny2N
BrainStorm Cell Therapeutics to Host KOL Webinar on Current Developments in the Treatment of Amyotrophic Lateral Sclerosis (ALS) on December 11, 2024
ir.brainstorm-cell.com
-
Ronald Faretra is a veteran living with #ALS who served 27 years in the U.S. Air Force. ✈️ Ron shares his tenacity with the #ALS community by helping to move the needle for the next generation of people that will be diagnosed. In the past two years, Ron played an instrumental role in South Carolina’s commitment to budget $500,000 for #ALS care services. ✨ We thank you for your service and for demonstrating that we are #BetterTogether. 🇺🇸 #VeteransDay #EndALS
-
This #VeteransDay, BrainStorm Cell Therapeutics recognizes Elizabeth Fassler, who served in the U.S. Army as a Tactical Control Officer for a Patriot missile battery. 🇺🇸 Elizabeth continues to serve others as a fierce advocate for the #ALS community by contributing to multiple committees, several of which focus on veteran-specific #ALS challenges. 💪🏻 Thank you for your service and relentless efforts to help #EndALS. ⚡️ #BetterTogether
-
Thank You Veterans for your sacrifice. We honor the extraordinary strength of those who continue to battle an #ALS diagnosis, in addition to your service. Your resilience inspires our mission at BrainStorm Cell Therapeutics to help end the suffering caused by #ALS. 🤝 #BetterTogether #EndALS
-
November is #NationalCaregiversMonth. BrainStorm Cell Therapeutics recognizes the dedicated caregivers that support people navigating the evolving challenges of #ALS. We remain committed to delivering meaningful treatment options that enhance the quality of life for people living with #ALS and their caregivers.
-
The Brainstorm Cell Therapeutics team is honored to attend and be a sponsor at the The ALS Association #ALSNexus meeting. We gained valuable insights from the sessions, our interactions with #ALS stakeholders including people living with ALS, their loved ones, advocates, researchers and physicians. We truly are #BetterTogether.
-
Thank you Andrea Pauls Backman, Rick Zwiep, Indu Navar, Layne Oliff and Jennifer DiMartino for participating in Brainstorm Cell Therapeutics' Global #ALSMND Day Campaign. Your commitment to partnership and global collaboration proves we are #BetterTogether. #ALSMNDWithoutBorders #EndALS EverythingALS ALS ONE ALS Action Canada Les Turner ALS Foundation The International Alliance of ALS/MND Associations Centers for Disease Control and Prevention Northeast ALS Consortium (NEALS) ALS Society of Canada Leigh H. Massachusetts General Hospital Dr. Shelena Lalji Team Gleason Foundation Mass General Department of Neurology I AM ALS National Institute of Neurological Disorders and Stroke (NINDS) The National Institutes of Health Foundation for the National Institutes of Health FDA Critical Path Institute (C-Path) UMass Chan Medical School ALS Therapy Development Institute Compassionate Care ALS The ALS Association
-
Jennifer DiMartino leads ALS ONE as executive director, serving as a vital link to the #ALS community since its inception in December 2015. ALS ONE is a unique partnership of top #ALS experts from renowned institutions including Mass General Department of Neurology, UMass Chan Medical School, ALS Therapy Development Institute and Compassionate Care ALS. ALS ONE collaborates with Northeast ALS Consortium (NEALS) on the ALS Research Publication Review series bridging the gap between authors of significant #ALS research publications and the #ALSMND community. Through this program, community members can ask questions to fully understand the research, while authors gain direct feedback from the community. ALS ONE provides people living with #ALSMND the resources and community required for their best quality of life. Jen is a passionate connector in the #ALSMND community. #ALSMNDWithoutBorders #BetterTogether #EndALS
-
Layne Oliff, a PharmD with decades of biopharma experience and a person living with #ALS, became a prominent advocate in the #ALS community in 2020. Layne contributes extensively through roles with the ALS Problem Solvers, Northeast ALS Consortium (NEALS) PEACe Committee, Mass General Department of Neurology HEALY Platform Patient Advisory Committee, The International Alliance of ALS/MND Associations, I AM ALS and the National Institute of Neurological Disorders and Stroke (NINDS) ALS Strategic Plan steering committee. Currently, Layne serves as the #pALS advisor to the Northeast ALS Consortium (NEALS) Executive Committee and as chairperson of the Accelerating Medicines Partnership (AMP ALS) People with lived experience (PWLE) working group. PWLE are integral to the AMP ALS technical working group alongside staff from The National Institutes of Health, Foundation for the National Institutes of Health, FDA and Critical Path Institute (C-Path). Layne's involvement highlights the value of including those with lived, or as Layne says, "living", experience. PWLE participation is crucial in every part of the #ALSMND community. #ALSMNDWithoutBorders #BetterTogether #EndALS