Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 207

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 207
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 below, in 2021 Kadimastem
completed a Phase 1/2a clinical trial of AstroRx®that began in April 2018, with the first patient treated in November
2018. The study was conducted at Hadassah Medical Center, Israel. Study protocols were approved by the Israeli Ministry of Health and
the institutional review board of Hadassah Medical Center in Jerusalem, Israel. Eligible participants were aged between 18 and 70 years
with a diagnosis of probable or definite ALS by revised El Escorial Criteria, within two years of diagnosis. The ALS Functional Rating
Scale-Revised, or ALSFRS-R score was higher than 30, and slow vital capacity, or SVC, was 70% or more of the predicted normal value for
height, age, and sex. Participants were either not receiving riluzole and/or edaravone or were on a stable dose for more than 30 days.
Potential patients were excluded for the following reasons: past infection or a positive test for hepatitis B, hepatitis C or HIV (human
immunodeficiency virus), need for respiratory support, renal failure, impaired hepatic function, body mass index under 18.5 or 30 or above,
significant cardiac disease, diabetes, autoimmune diseases, chronic severe infection, malignant disease or any other disease or condition
that may risk the patient or interfere with the result of the study. By the end of December 2019, ten patients were treated with
AstroRx®: five patients from Cohort A had been treated with 100 million AstroRx®cells injected into
their spinal fluid. Subsequently, five patients from Cohort B were treated with 250 million AstroRx®cells, with the
last patient being treated in December 2019. During 2020, clinical data was collected for the treated patients for up to 12 months.
Considering the spread of COVID-19 in Israel and following the data and safety monitoring board recommendation to suspend the continuation
of the clinical trial in the third and fourth treatment groups, Kadimastem decided to discontinue the recruitment to additional treatment
groups in ALS Phase 1/2a trial.

Safety outcomes: Nine out of 10 (90%) of treated
patients completed the six-month follow-up, and 6 patients (60%) completed the twelve-month follow-up. All patients reported a total of
86 treatment-emergent adverse events, or TEAE. None of the TEAEs was deemed to be