The Grant will support the Further Development of Cell Therapy Product AstroRx®, for the Treatment of ALS
And support the Company’s FDA IND enabling studies
For its next clinical trial in ALS patients
NESS ZIONA, ISRAEL, March 3, 2022 – Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, has received a grant from the Israel Innovation Authority (IIA) for a total budget of NIS 10 million ($3.1 million) and a net grant of NIS 4 million ($1.25 million).
The funds will be used to advance the filing of an IND with the FDA by the end of 2022, to secure the approval of the FDA of the anticipated Phase IIa, US, multicenter, clinical trial protocol of AstroRx® for the treatment of ALS and expand the use of AstroRx® cell product for other neurological conditions such as multiple sclerosis and glaucoma.
Kadimastem CEO Asaf Shiloni said, "This grant is an important expression of trust by the Israeli Innovation Authority in Kadimastem and the potential of our clinical, cell therapy platform to provide millions of patients worldwide with life-saving treatments. The Company is currently in one of the most significant periods in its history, both clinically and financially. We are scaling-up for a Phase IIa clinical trial of AstroRx® for ALS in the US as well as preparing to list on NASDAQ. This grant provides us with the necessary resources to advance both sets of plans.”
Prof. Michel Revel, Chief Scientist of Kadimastem: "We thank the Innovation Authority for supporting Kadimastem, its work and its vision."
This is the second grant awarded to Kadimastem in the past months by the IIA. The previous grant was earmarked for the scale-up of the production of AstroRx® as well as for creating a frozen, off-the-shelf product, to ensure the clinical quality of the product for patients worldwide.
In 2019, Kadimastem completed a first-of-its-kind, Phase I/IIa clinical trial of AstroRx®, whereby the treatment was injected into the spinal cord fluid of 10 patients in a standard lumbar puncture procedure. AstroRx® showed high safety profile and significantly slowed the rate of disease progression for 3 months following treatment, as measured by the ALSFRS-R.
Dr. Michal lzrael, VP of R&D
Dr. Michal lzrael, VP of R&D said, “The grants the Company has received from the IIA for the development and clinical production of Kadimastem’s cellular, off-the-shelf AstroRx® product are a clear recognition of the company's innovative technology. Astrocytes, the support cells in the nervous system, which are the basis for the AstroRx® product, have enormous therapeutic potential to protect all types of nerve cells. We are working hard to bring a product to market that will help to improve the lives of ALS patients worldwide as well as to development this therapy for other neurodegenerative diseases such as multiple sclerosis and glaucoma."
Kadimastem is a clinical stage cell therapy company, developing and manufacturing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS. IsletRx is the company's second product in development. IsletRx is comprised of functional, insulin producing, pancreatic islet cells intended to treat and cure patients with insulin-dependent diabetes. IsletRx demonstrated safety and efficacy in a proof-of-concept preclinical study. An INTERACT meeting took place with the FDA on October 7, 2021, where the diabetes treatment program was discussed, and the company received directions how to prepare its Pre-IND submission. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
Forward Looking Statement
This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.
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