A peer reviewed article on Kadimastem's AstroRx® Cryopreserved off the Shelf Cell Product for the Treatment of ALS was Published in the Journal of Clinical Toxicology
- Jan 25, 2024
- 3 min read
The publication presents the development and preclinical safety of Kadimastem's off the shelf AstroRx ("thaw to inject") cell product in comprehensive toxicity studies
Ness Ziona, Israel, January 25th 2024, Kadimastem (TASE: KDST), a well-known biotech company in the field of cellular therapy, which is in the clinical development stages of innovative products for the treatment of ALS and diabetes, announced today the publication of the peer-reviewed prestigious journal of Clinical Toxicology. The article describes the development and safety of the new off the shelf cryopreserved AstroRx cell product in toxicity studies. Intrathecal injection of both low dose of DMSO (vehicle control) used for cryopreservation of human astrocytes and the cryopreserved AstroRx® cell product demonstrated high safety profile in mice. Link to the article.
The article details the important milestone achieved by the company in the development of cryopreserved AstroRx® off the shelf cell product that will be thawed and injected near the patient's bedside. The development of a cryopreserved cell therapy product would allow the completion of more accurate and longer sterility testing, the completion of potency results, simplify the process of manufacturing scaling, enable long term storage and transport and facilitate timing of therapy delivery to the patient. The Cryopreserved product will help secure the clinical objectives of the upcoming IND approved phase IIa clinical trial in 30 ALS patients.
Kadimastem production team members with AstroRx®
Kadimastem production team members with AstroRx®
Kadimastem's AstroRx® cell product is an allogeneic cell-based product composed of healthy and functional human astrocytes derived from embryonic stem cells. AstroRx® acts through multiple mechanisms of action that increase the survival of neurons, such as removal of toxic excessive glutamate, reduce oxidative stress, secrete various neuroprotective factors, and act as an immunomodulator.
Dr. Michal Izrael, Kadimastem's VP R&D says: “The new formulation of cryopreserved of the shelf AstroRx® cell product (“thaw and inject”) is of great importance for product commercialization as well as to the success of our upcoming phase II clinical study, as it permits coordination of cell administration with patient care and completion of safety and quality control testing before cell administration.”
Asaf Shiloni, Kadimastem’s CEO says: “We would like to thank Kadimastem's dedicated team for achieving this significant milestone. We are very excited to move towards our next Phase IIa clinical study approved by the FDA, with the new off-the-shelf AstroRx® cell product which will be tested using repeated intrathecal injections of AstroRx® in ALS patients.”
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 and in pre-clinical studies for other neurodegenerative indications.
IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional, insulin and glucagon producing and releasing pancreatic islet cells, intended to treat and potentially cure patients with insulin-dependent diabetes.
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.
Company Contacts:
Asaf Shiloni
CEO
It is incredibly exciting to see the publication of this peer-reviewed article in the Journal of Clinical Toxicology. The development of a cryopreserved, "off-the-shelf" AstroRx product marks a significant milestone in making advanced ALS treatments more accessible and scalable. The scientific rigor behind these toxicity studies and the potential for multi-mechanism neuroprotection provide a lot of hope for the upcoming clinical trials.
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This peer-reviewed publication is such a significant milestone for the field of regenerative medicine! It's fascinating to see the development of "thaw-to-inject" technology and how it can streamline the delivery of advanced cell therapies. The potential for these astrocytes to support neuron survival and slow disease progression offers so much hope for the future of treatment.
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This peer‑reviewed article on Kadimastem’s AST‑RoRx cryopreserved off‑the‑shelf cell product is incredibly informative and highlights some exciting advancements in regenerative medicine. It's inspiring to see research pushing the boundaries of what's possible in therapeutic treatments and patient care. In a world where innovation matters in both science and self‑care, it’s also important to pay attention to personal wellness routines like scalp care to support everyday health and balance. Similarly, treatments such as High Frequency Facial provide rejuvenation and reflect how wellness continues to evolve. Thank you for sharing such a compelling study!
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This peer‑reviewed article on Kadimastem’s AST‑ROX cryopreserved off‑the‑shelf cell product is a fascinating read — it’s exciting to see rigorous science and innovation coming together in ways that could really advance treatment options. The level of research and validation here speaks volumes about the importance of careful development and evidence‑based progress in medical science. It even made me think about how thoughtful engineering and quality choices matter in completely different fields too — whether it’s cutting‑edge biotech or industries like marine insulation companies & marine pipe insulation, where expertise and precision behind the scenes are essential for performance and reliability. Really appreciate seeing this work highlighted!