Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 404

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 404
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 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 for measuring the statistical significance of experimental results; p -valueof less than 0.05 indicates statistically significant result), which was not maintained at 6- and 12 -monthfollow -up. The change in the ALSFRS -Rslope was also analyzed in a subpopulation of rapid progressors from both groups (