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Old 02-22-2019, 01:40 PM
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Default MSC stem cell therapy clinical trial launching for progressive MS

BrainStorm Announces First Contracted U.S. Clinical Site for Phase 2 Progressive MS Study
Phase 2 Open-Label Trial of Autologous MSC-NTF Cell Therapy (NurOwn®) in Progressive MS Patients will Begin Enrollment in Early 2019

February 22, 2019 07:30 ET | Source: BrainStorm Cell Therapeutics Inc.

NEW YORK and CLEVELAND, Feb. 22, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today Cleveland Clinic as the first U.S. clinical site contracted for a planned Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous MSC-NTF cells in participants with progressive Multiple Sclerosis (MS). The Phase 2 study (NCT03799718) will enroll progressive MS patients [Expanded Disability Status Scale (EDSS) 3.0-6.5] based on 2017 revised McDonald Criteria.

MS is a chronic neuroinflammatory and neurodegenerative disorder that affects the brain and spinal cord. MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.

“We are very excited to announce The Mellen Center for MS Treatment and Research at Cleveland Clinic as the first contracted U.S. clinical site for this very important Phase 2 progressive MS study that we plan to initiate in early 2019,” said Chaim Lebovits, president and CEO of BrainStorm. “This is a crucial step forward toward rapidly enrolling a Phase 2 study to evaluate this innovative autologous cell therapy approach using our NurOwn® technology platform in progressive MS patients.”

“Progressive MS treatment options are limited and do not directly address unmet need”, said Ralph Kern MD MHSc, COO and CMO of BrainStorm, “This phase 2 clinical trial is an important part of our commitment to bring a new treatment modality and hope to MS patients”.

Cleveland Clinic is currently ranked as the No. 2 hospital in the country, according to U.S. News & World Report (2017-2018). The Mellen Center for Multiple Sclerosis Treatment and Research at Cleveland Clinic is one of the largest and most comprehensive programs for MS care and clinical research worldwide, managing over 8,000 patients and over 21,000 total visits annually.

Trial Page (not recruiting just yet)
https://clinicaltrials.gov/ct2/show/NCT03799718
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Old 03-19-2019, 12:11 PM
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BrainStorm Announces First Patient Enrolled in Phase 2 Clinical Trial of Progressive MS

03/14/2019

Enrollment Announced During MS Awareness Week

NEW YORK and CLEVELAND, March 14, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the first patient has been enrolled in its Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous MSC-NTF cells in participants with progressive Multiple Sclerosis (MS).

Chaim Lebovits, president and CEO of BrainStorm stated, “Midway through MS Awareness Week: March 10-16, we are pleased to announce the first participant with progressive MS has been enrolled in our Phase 2 clinical trial. Progressive MS has deeply affected the lives of many and dramatically impacted family members, caregivers and others. Today, there is no U.S. FDA approved therapy addressing more than one progressive form of MS and we are pleased to deploy our NurOwn® technology platform in this new indication. Soon, we will announce additional sites where the clinical trials will be conducted.”

“The first participant enrolled in our Phase 2 trial represents an important milestone in our commitment to address the unmet medical need in progressive MS,” said Ralph Kern, MD MHSc, Chief Operating and Chief Medical Officer of Brainstorm. “We plan to quickly initiate enrollment across all study sites and look toward top line data by the middle of 2020.”

MS is a chronic neuroinflammatory and neurodegenerative disorder that affects the brain and spinal cord. MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive form of the disease, which may lead to increased levels of motor, visual, and cognitive functional impairment and disability.

For more information, refer to www.clinicaltrials.gov, using the NCT identifier (NCT03799718).
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