Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 409

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 409
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also secretes several inhibitors of metalloproteases as well as a variety of neuroprotective factors (e.g. TIMP -1, TIMP -2, OPN, MIF and Midkine). Intrathecal injections of the AstroRx ®into transgenic hSOD1 G93Amice and rats significantly delayed disease onset and improved motor performance compared to sham -injectedanimals. A safety study in immunodeficient mice showed that intrathecal transplantation of AstroRx ®demonstrated positive results. Transplanted AstroRx ®attached to the meninges along the neuroaxis and survived for the entire duration of the study without formation of tumors or teratomas. Cell -injectedmice gained similar body weight to the sham -injectedgroup and did not exhibit clinical signs that could be related to the treatment. No differences from the vehicle control were observed in hematological parameters or blood chemistry. PMID: 32848579: Rising Stars: Astrocytes as a Therapeutic Target for ALS Disease This paper describes the role of Astrocytes malfunction in several neurodegenerative diseases and specifically in LAS. Astrocytes impaired biological functionality were implicated in multiple neurodegenerative diseases, including ALS, FTD, Parkinson’s and Alzheimer’s. In ALS disease patients, A1 reactive astrocytes were found to play a key role in the pathology of ALS disease and death of motor neurons, via loss or gain of function or acquired toxicity. The contribution of astrocytes to the maintenance of motor neurons by diverse mechanisms makes them a promising therapeutic candidate for the treatment of ALS. Therapeutic approaches targeting at modulating the function of endogenous astrocytes or replacing lost functionality by transplantation of healthy astrocytes, may contribute to the development of therapies which might slow down or even halt the progression ALS diseases. The proposed mechanisms by which astrocytes can potentially ameliorate ALS progression and the status of ALS clinical studies involving astrocytes are discussed. In the Phase 1/2a trial of AstroRx ®, when applied to humans, these effects were not observed at 6- and 12 -monthfollow -uptime points. As so, Kadimastem believes that it is more likely that AstroRx ®astrocytes will be more effective in treating diseases than single -moleculebased drugs, e.g. Riluzole (assumed to improve glutamate uptake and to reduce excitotoxicity), or Edaravone (a reactive oxygen species, reducing oxidative stress).