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|Brainstorm Issues 2017 Letter to Shareholders|
Dear Valued Shareholders,
This past year was an extraordinary success for
In October, we enrolled the first patients in the randomized, double-blind, placebo-controlled multi-dose Phase 3 clinical trial of NurOwn® for the treatment of ALS. Our Phase 3 trial builds upon the promising efficacy demonstrated in our Phase 2 randomized US trial, the first ALS study data to highlight the restoration of patient function.
As the most advanced stem cell therapy in development for the treatment of ALS, our Phase 3 trial will enroll approximately 200 patients at six leading clinical sites in the U.S. The NurOwn® phase 3 trial patient population will focus on the patient sub-groups which demonstrated superior outcomes in the Phase 2 ALS clinical trial. The primary outcome measure will be the ALSFR-S score responder analysis, a score that measures a patient's ability to perform tasks that are affected by ALS. We expect interim safety data in mid 2018 and top-line data in late 2019. The phase 3 trial will also expand upon phase 2 biomarkers to further evaluate their potential to predict ALS disease progression and NurOwn® treatment response.
The pivotal phase 3 NurOwn® trial is being supported by a
We met and exceeded expectations in 2017 on the manufacturing and product development front. As an important milestone for potential commercialization, in early 2017 our NurOwn® cryopreservation process was validated for the Phase 3 clinical study for treatment of ALS. Additionally, to further expand our manufacturing capabilities, we contracted the
We continue to explore strategic partnerships to advance NurOwn's clinical development and maximize its market potential. In 2017 we signed a Memorandum of Understanding (MOU) to explore the possibility of making NurOwn® available to ALS patients under provision of the MOH Hospital Exemption regulation with
In addition, this year we expanded our patent portfolio by obtaining an additional US patent for BrainStorm's NurOwn® technology for the treatment of ALS and Parkinson's disease. This move further protects our technology and is a result of BrainStorm's ongoing development and clinical successes.
In parallel to our NurOwn® successes, we strengthened our executive team and board of directors. We added three senior members to our executive team:
Our Board of Directors was strengthened in February with the addition of
This year, in addition to support enrollment in the Phase 3 ALS clinical trial, we are also looking to advance BrainStorm's pipeline in other neurodegenerative diseases, based on strong preclinical data in Parkinson's disease and Multiple Sclerosis.
In closing, management is dedicated to achieving our primary goals to deliver value for our shareholders, to develop transformative cell therapies for ALS and other severe neurodegenerative diseases, and to be the leader in this field. We have accomplished much in the past year but there is no doubt in our mind that our best days are ahead of us. Thank you for your continued interest in and commitment to support Brainstorm.
Please do not hesitate to contact us directly with any additional questions; we can be reached at firstname.lastname@example.org
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