NEW YORK, Dec. 28, 2020 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a primary developer of mobile therapies for neurodegenerative disorders, today declared the pursuing letter from its Main Government Officer, Chaim Lebovits, to its shareholders and the expenditure neighborhood.
Pricey Valued Shareholders,
I am extremely happy of the remarkable development BrainStorm created as a organization in 2020. The many scientific and corporate milestones we have achieved this year are a testament to the expertise and unwavering dedication of our staff members, companions and investigators. I deeply recognize the get the job done they have completed, and their capacity to execute in this difficult COVID setting. I want to thank in particular the sufferers and caregivers, who showed a steadfast dedication to our medical trials in spite of the pandemic. We stay committed to bringing NurOwn® to patients with neurodegenerative disorders as a substantially-desired cure solution. In addition, we are increasing our pipeline with the application of our exosome system technological innovation to contain new indications that have sizeable unmet medical require.
BrainStorm’s most important medical milestone of 2020 was the well timed completion of the NurOwn® Period 3 ALS medical demo, even with the difficulties of COVID-19. We believe that the totality of evidence that we have produced are supportive of NurOwn’s medical gain. We are diligently pursuing future ways, together with energetic discussions with the United States Food stuff and Drug Administration (Fda) to recognize regulatory pathways that may well help NurOwn’s acceptance in ALS.
Though we did not display statistical significance in the key efficacy endpoint in the total review populace, pre-specified analyses propose that NurOwn® has a clinically meaningful remedy influence. For case in point, in a pre-specified participant subgroup with early ailment and preserved function primarily based on the ALSFRS-R baseline rating, NurOwn® showed the predicted numerically remarkable cure reaction in comparison to placebo. In addition, phase 3 cerebrospinal fluid neurodegenerative and inflammatory biomarkers were continually modified by NurOwn treatment method, supporting NurOwn’s proposed system of motion in ALS. We are grateful to the Food and drug administration for prioritizing our IND, as we and the Agency clearly realize the urgency essential for ALS people.
Subsequent the completion of our Section 3 ALS scientific demo, we not long ago initiated an Expanded Accessibility System (EAP) to deliver NurOwn® treatment for people who finished the Stage 3 demo and meet particular eligibility requirements. This EAP was developed in partnership with the Food and drug administration and will get put at the 6 scientific centers of excellence that participated in the trial. Initiating the EAP quickly following the Section 3 trial’s completion speaks to the assure of NurOwn’s phase 3 medical facts, the urgent unmet professional medical need for ALS clients and our determination to sufferers. The ALS health practitioner, advocacy and affected person local community feedback on the EAP has been really good.
In parallel with the medical systems to progress NurOwn, Brainstorm is also functioning to establish the producing capacity needed for a commercial ramp up. To this result, we engaged in strategic partnerships to develop our Recent Good Producing Practice (cGMP) capabilities. Our tech transfer to Catalent has currently been initiated and will allow for for continual source of NurOwn® for upcoming medical trials and preliminary commercialization. Our perform with Rapid Reshore & Enhancement, to help BrainStorm build in-residence producing abilities, will accelerate as soon as a regulatory pathway is crystal clear. These agreements will help to ensure an ongoing cGMP medical supply of NurOwn® and will be integral to making sure rapid entry for people pursuing a possible regulatory acceptance. We also signed a lease agreement with the Tel Aviv Sourasky Healthcare Centre (Ichilov Healthcare facility) in Tel Aviv, Israel, to generate NurOwn® in 3 condition-of-the-artwork cleanrooms. The new facility will considerably increase our manufacturing ability, positioning us to strategically enter the European and Israeli marketplaces. In addition to our medical data evaluation, we are also in energetic dialog with the Food and drug administration all over this element of NurOwn’s regulatory assessment. I am content to share with you that we have lately had a successful assembly with the Food and drug administration pertaining to Chemistry, Manufacturing and Controls (CMC). We will present an update when the minutes are finalized.
We have manufactured superb development in our NurOwn clinical plan in progressive MS, inspite of some delays in medical trial enrollment due to COVID-19 healthcare limits. The future milestone will be the generation of prime line benefits from our entirely dosed Section 2 trial which we count on by the end of to start with quarter 2021. Specific analyses of the comprehensive examine clinical and biomarker dataset can enable display the possible of NurOwn know-how in progressive MS. The broader aim for NurOwn is to proceed to expand a solid body of evidence for NurOwn in ALS, MS in addition to other neurodegenerative diseases.
As aspect of our technique to progress the NurOwn engineering and grow our pipeline, we introduced before this 12 months a new scientific application in Alzheimer’s condition. NurOwn has the functionality to at the same time target various relevant Alzheimer’s condition pathways and bring a in depth technique that addresses equally neurodegeneration and neuroinflammation. This is a basically different approach to a lot of previous Alzheimer’s therapies which have concentrated on a solitary goal this kind of as tau or beta-amyloid. We intend to perform a 52-week, Phase 2 open-label, proof-of-strategy medical trial to assess NurOwn in 40 members with prodromal to delicate Alzheimer’s ailment. The trial will be executed at the Mind Investigate Facilities affiliated with the Alzheimer Middle Amsterdam, Pitié-Salpêtrière Medical center (Paris), and many other clinical demo internet sites in the Netherlands and France.
We were being also delighted to announce a new plan using our exosome-centered system-technological innovation for the therapy of serious COVID-19 an infection and released proof-of-idea results from a pre-scientific review. In the pre-clinical examine in mice, we demonstrated that intratracheal administration of exosomes extracted from Mesenchymal stem cells resulted in a statistically sizeable enhancement in numerous lung parameters. The final results from this research have been accepted and will be published in a peer-reviewed professional medical journal in 2021. We are actively assessing following measures to determine the greatest route ahead with our exosome platform.
We manufactured important additions to the senior administration group for the duration of 2020 including Dr. David Setboun as Main Operating Officer and Dr. Stacy Lindborg as Head of World-wide Clinical Exploration. Dr. Setboun has in depth experience in the biopharmaceutical business possessing held crucial leadership roles in commercial growth and product launches at Biogen. Dr. Lindborg is an knowledgeable healthcare government and globally recognized healthcare statistician with about two decades of multinational working experience in R&D, regulatory drug approvals, tactic development, analytics and massive details at Lilly and Biogen. Prof. Jacob Frenkel joined us as Chairman of our Board before in the yr. These appointments, as properly as the other new hires, are part of a strategic initiative to develop a senior workforce with verified business capabilities, as we transition to potentially becoming a professional group.
Seeking forward to 2021, our key emphasis spots are to arrive at arrangement with Fda on a path for regulatory approval NurOwn® in ALS, to produce prime-line effects for our Period 2 MS examine in the very first quarter, to progress our Phase 2 Alzheimer’s condition trial, to develop our exosome-dependent engineering, and to additional produce our mobile engineering and production capabilities and infrastructure.
In 2021, we will leverage our potent economical posture with about $40 million in hard cash and our experienced crew will proceed to be influenced by the ALS individuals to deliver our progressive therapy choice ahead whilst providing price to our shareholders.
I would like to thank you for your continued help.
Main Govt Officer
BrainStorm Cell Therapeutics Inc.
Statements in this announcement other than historic info and information and facts, like statements relating to long run medical trial enrollment and knowledge, represent “forward-looking statements” and contain hazards and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s true benefits to vary materially from all those said or implied by these ahead-wanting statements. Conditions and phrases such as “might”, “need to”, “would”, “could”, “will”, “hope”, “very likely”, “think”, “approach”, “estimate”, “forecast”, “potential”, and similar conditions and phrases are meant to determine these forward-seeking statements. The opportunity pitfalls and uncertainties incorporate, without limitation, BrainStorm’s need to elevate supplemental capital, BrainStorm’s ability to keep on as a likely issue, regulatory acceptance of BrainStorm’s NurOwn® treatment candidate, the achievement of BrainStorm’s product progress applications and research, regulatory and personnel troubles, growth of a worldwide marketplace for our companies, the potential to safe and keep analysis institutions to perform our medical trials, the ability to deliver considerable earnings, the means of BrainStorm’s NurOwn® therapy prospect to attain broad acceptance as a treatment method selection for ALS or other neurodegenerative health conditions, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, acquiring patents that provide meaningful protection, competitors and market place developments, BrainStorm’s ability to protect our intellectual house from infringement by third functions, heath reform laws, demand for our expert services, forex exchange rates and products liability statements and litigation, and other factors in depth in BrainStorm’s annual report on Form 10-K and quarterly studies on Kind 10-Q readily available at http://www.sec.gov. These components really should be regarded very carefully, and readers should really not position undue reliance on BrainStorm’s forward-looking statements. The forward-wanting statements contained in this press release are dependent on the beliefs, expectations and viewpoints of administration as of the date of this push launch. We do not believe any obligation to update ahead-hunting statements to mirror real success or assumptions if instances or management’s beliefs, anticipations or views need to transform, unless otherwise expected by law. Whilst we believe that that the anticipations mirrored in the ahead-seeking statements are sensible, we are not able to guarantee potential success, stages of activity, performance or achievements.
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Phone: +1 646-465-1138
Telephone: + 1.973.713.3768
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