Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 413

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 413
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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 and 34.9 ± 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 AstroRx ®cell injection, the mean decline of the ALSFRS -Rslope was attenuated to − 0.3/month (p = 0.039), reflecting an attenuation of 66% in ALSFRS -Rdeterioration. Combining the data of both groups demonstrated an attenuation of 53% in ALSFRS -Rover the first 3 months post AstroRx ®IT injection (p < 0.001) (a p -valueis a conventional statistical method