Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 265

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 265
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elfproduct improved the streamlined production processes and allow Kadimastem to transport AstroRx ®frozen cell product from one (or more) production facility to anywhere in the world, at any point in time, without Kadimastem having to synchronize the production process with the exact date of injection of the product to any patient. Kadimastem conducted several trials that supported the stability of the frozen AstroRx ®product and that the freezing process did not change the characteristics of the product. In addition, AstroRx ®successfully passed toxicity studies. The final chemistry, manufacturing and controls data was submitted to the FDA in the Investigational New Drug, or IND, application and the FDA approved the conduction of Phase IIa clinical trial in March 2023. Kadimastem intends to initiate a Phase IIa multisite study in the United States shortly following the closing of the Merger. 134 As described in more detail below, in 2021 Kadimastem completed a Phase 1/2a clinical trial of AstroRx ®that began in April 2018, with the first patient treated in November 2018. The study was conducted at Hadassah Medical Center, Israel. Study protocols were approved by the Israeli Ministry of Health and the institutional review board of Hadassah Medical Center in Jerusalem, Israel. Eligible participants were aged between 18 and 70 years with a diagnosis of probable or definite ALS by revised El Escorial Criteria, within two years of diagnosis. The ALS Functional Rating Scale -Revised, or ALSFRS -Rscore was higher than 30, and slow vital capacity, or SVC, was 70% or more of the predicted normal value for height, age, and sex. Participants were either not receiving riluzole and/or edaravone or were on a stable dose for more than 30 days. Potential patients were excluded for the following reasons: past infection or a positive test for hepatitis B, hepatitis C or HIV (human immunodeficiency virus), need for respiratory support, renal failure, impaired hepatic function, body mass index under 18.5 or 30 or above, significant cardiac disease, diabetes, autoimmune diseases, chronic severe infection, malignant disease or any other disease or condition that may risk the patient or interfere with the result of the study. By the end of December 2019, ten patients were treated with AstroRx ®: five patients from Cohort A had been treated with 100 million AstroRx ®cells injected into their spinal fluid. Sub