Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 413

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 413
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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 (n = 5). Rapid progressors were defined as patients who deteriorated ≥ 1.1 ALSFRS -Rpoints per month during the run -inperiod. The mean improvement in ALSFRS -Rslope between the run -inperiod and 3 -monthfollow -upin these patients was 58% (− 1.58/month vs. − 0.65/month, p < 0.001). Also in this subpopulation, after 3 months post single dosing the ALSFRS -Rslope returned to a similar rate that was recorded before treatment (Fig. 2). 208 An improvement ≥ 25% in the ALSFRS -Rslope is considered clinically meaningful. The individual ALSFRS -Rslopes demonstrated an improvement of at least 25% in ALSFRS -Rslope between the run -inand 3 -monthfollow -upin 80% of the patients (4 patients in each group, data not shown). At 6 and 12 months after treatment, the ALSFRS -Rdeterioration rate was − 0.76/month and − 0.82/month, respectively, similar to that observed during run -in. The mean deterioration of ALSFRS -Rslope in Group B (− 1.43/month) during the run -inwas greater than Group A (− 0.88/month). Similar to Group A, the ALSFRS -Rdeterioration rate during the first 3 months after treatment decreased to − 0.78/month (p = 0.002), representing an attenuation of 45% in ALSFRS -Rdecline. As observed in Group A, the attenuation of ALSFRS -Rdecline over the first 3 months