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'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).
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Asaf Shiloni CEO
