Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 379

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 379
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 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 post -treatmentwas not maintained at 6 and 12 months post -treatment(− 1.59/month and − 1.39/month, respectively). FDA approved planned Phase 2a study:In March 2023, Kadimastem received approval from the FDA regarding its AstroRx ®multisite -sitePhase 2a clinical trial study in the United States based on the IND application. The application includes a detailed clinical synopsis approved by the FDA. Briefly, the studies titled: “A Prospective, Randomized, Double -Blind, Placebo Controlled, Phase 2a Study For 6 Months, followed by a 6 -MonthOpen -LabelExtension to Evaluate the Safety, Tolerability, And Effectiveness of Repeated Administration of Cryopreserved AstroRx ®in Patients with Amyotrophic Lateral Sclerosis (ALS)”. This study will be conducted in participants with a sporadic or familial ALS, who meet the El Escorial criteria of probable, or definite criteria for a diagnosis of ALS, with disease onset of 18months or less, from first symptoms until screening. At screening, eligible participants must be between ages 18 -80years old, have an ALSFRS -Rscore ≥35, and a SVC ≥70% of predicted capacity for age, height and gender. Participants on a stable dose of riluzole and/or edaravone or PB (sodium phenylbutyrate)/TURSO (taururs