For the Support of Production Scale Up of Astrocyte cells Used to Produce ALS Cell Therapy Treatment AstroRx® in Preparation for Phase IIa a Multi-site Clinical Trial
Kadimastem Plans to Submit an IND for a Phase IIa FDA
Clinical Study of AstroRx® for ALS by the End of 2022
NESS ZIONA, ISRAEL, December 12, 2021 – 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 of NIS 1.6 million ($500K), 40% of the approved budget of NIS 4 million ($1.29M) from the Israel Innovation Authority (IIA).This brings the total amount of financing raised by Kadimastem in 2021 to NIS 51.6 million ($16 M).
Shir Klein-Lavi- Research Assistant at Kadimastem
As Kadimastem intends to submit the IND for the Phase IIa clinical study before the end of 2022, the IIA funding will be used to scale up the production of a frozen, off-the-shelf product of AstroRx® in preparation for the trial. Using large reactors and special tools, hundreds of millions of high-quality astrocyte cells, the brain supporting cells that comprise AstroRx®, will be produced for the clinical trial, as well as for future commercialization purposes for the benefit of the hundreds of thousands of ALS patients worldwide.
Kadimastem has already completed a Phase I/IIa clinical trial (ClinicalTrials.gov Identifier: NCT03482050). This trial was the first of its kind in the world, whereby the supporting cells of the central nervous system (AstroRx®), produced by the company, were injected into the spinal fluid of patients, in a standard lumbar puncture procedure.
Five ALS patients were injected with 100 million cells and five patients were injected with 250 million cells. The results of both doses demonstrated a high safety profile. No serious treatment-related side effects were reported and no side effects limiting the treatment dose were found.
In order to determine initial efficacy, an analysis was performed comparing the rate of disease progression according to the ALSFRS-R index in the pre-treatment follow-up period and the post-treatment follow-up period. It was found that with both doses the rate of disease progression slowed significantly during the three months following injection.
In light of these clinical trial results, in the next study, the company intends to examine if dosing every three months with the cellular off-the-shelf AstroRx® product prolongs the therapeutic effect.
Kadimastem CEO Asaf Shiloni said, "In the past year, Kadimastem has experienced an unprecedented show of support from both existing and new investors. Today’s grant by the Israeli Innovation Authority is another strong endorsement of the company’s important work in developing an improved therapeutic treatment for the millions suffering from debilitating neurological diseases. Kadimastem is at an exciting turning point and this grant supports us with the necessary resources to advance the plans for the quantitative production of the company's flagship product - AstroRx®. In other words, after this past year’s fund raising, we now have the capital to create increased quantities of brain supporting cells, enough to truly make a big difference in helping the hundreds of thousands of ALS patients worldwide."
Chief Scientist of Kadimastem Professor Michel Revel said, "We thank the Israel Innovation Authority for its continued support and for further helping Kadimastem to proceed on this very worthwhile journey."
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. In November 2021, the company announced its intention to list on NASDAQ.
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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