Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 266

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 266
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sequently, 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 -19in 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 -monthfollow -up, and 6 patients (60%) completed the twelve -monthfollow -up. All patients reported a total of 86 treatment -emergentadverse events, or TEAE. None of the TEAEs was deemed to be associated with AstroRx ®itself. 63 TEAEs were mild, 19 were moderate, and 4 were severe. Six patients developed a total of 9 serious TEAEs after the treatment, 2 patients in Group A and 4 patients in Group B. The most frequent TEAE was post lumbar puncture headache, associated with IT injection procedure of the cells, and reported by 50% of the patients. Additional procedure -relatedTEAEs included pain in the injection site (30%), arthralgia, back pain, muscle contraction, and pain in the leg, each reported by 10% of the patients. All procedure -relatedadverse events, or AEs, were graded as mild to moderate, and all were resolved. Three patients reported 4 AEs related to mycophenolate mofetil, including headache, nausea, anemia, and hyperhidrosis. All the immunosuppression -relatedAEs were graded as mild to moderate, and all were resolved. The main outcome efficacy measure in the study was ALSFRS -R. At baseline visit (1 day before treatment) the mean ALSFRS -Rscore was 35.6 ± 3.7, 34.2 ± 7.0 and34.9 ± 5.3, for Group A, Group B, and combined Group A + B, respectively. The mean decline in the ALSFRS -Rslope for patients in Group A was − 0.88/month during the run -in(3 – 4 months before treatment). In the first 3 months after Astro