Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 204

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 204
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 and secretion of a variety of potent neurotrophic factors. For example, disruption of
the astrocytic TNFR1 - GDNF axis accelerates MN degeneration and disease progression, as the levels of the protective
agents for MNs, glial-derived neurotrophic factor, are reduced. AstroRx®were tested in vitro, in vivo (animal studies)
and on human subjects, as described in the following peer reviewed papers:

PMID: 36788520: Safety and efficacy of first-in-man
intrathecal injection of human astrocytes (AstroRx®) in ALS patients: phase I/IIa clinical trial results. This paper describes
the results of Phase 1/2a NCT0348205010 clinical trial (further described on page 137).

PMID: 29871694: Safety and efficacy of human
embryonic stem cell-derived astrocytes following intrathecal transplantation in SOD1 G93AThis
paper describes the development of good manufacturing practice-grade protocol for generation of astrocytes from human embryonic stem cells
(AstroRx®), their in vitro function, their efficacy in ALS animal model (hSOD1G93Atransgenic mice) and their
safety and biodistribution in a 9-month study conducted in immunodeficient NSG mice under good laboratory practice conditions. In vitro,
AstroRx®possess the activities of functional healthy astrocytes, including glutamate uptake, promotion of axon outgrowth
and protection of MNs from oxidative stress. A secretome analysis shows that AstroRx®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 hSOD1G93Amice and rats significantly delayed disease onset and improved motor
performance compared to sham-injected animals. 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-injected mice gained similar body weight to the sham-injected
group and did not exhibit clinical signs that could be related to the treatment. No differences from the vehicle control were observed