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Kadimastem Expands R&D Program to Include Multiple Sclerosis

Following positive results from its first clinical study in ALS, Kadimastem Tests The Potential of AstroRx® As A Therapeutic Treatment For MS in Pre-Clinical Study Conducted in Cooperation With Hadasit Medical Research Services and Development Ltd.


Kadimastem remains on track to submit IND to the FDA before the end of 2022 to begin a multicenter clinical trial of AstroRx® for ALS in 2023 in the U.S.


 

Ness Ziona, Science Park, May 18, 2022 - Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, is expanding its R&D activity with the exploration of developing a treatment for Multiple Sclerosis (MS).

As part of this initiative, the company has signed a service agreement with Hadasit Medical Research Services and Development Ltd. Hadasit is the technology transfer arm of Hadassah Medical Center. It is well known for its partnerships with international companies and research institutions, and its success with groundbreaking medical developments that fill unmet market needs.

Under the terms of the agreement, Kadimastem’s astrocyte cells, which comprise AstroRx®, the company’s flagship product for ALS, will be tested for their therapeutic potential for MS using a unique animal model in Professor Tamir Ben-Hur’s laboratory at Hadassah Medical Center. Professor Ben-Hur is the Director of Brain Medicine at Hadassah Ein Kerem Medical Center and a pioneer and opinion leader in the field of clinical research in multiple sclerosis.


Dr. Michal Izrael Picture by Kadimastem


If successful, the goal is to thereafter plan and conduct a clinical trial of AstroRx® for MS.

"We are very excited about the expansion of the range of neurological diseases that astrocyte cells (AstroRx®) could be used to treat. The pre-clinical study that will be conducted at Professor Ben-Hur's laboratory is extraordinary. It’s a first-of-its-kind in the world to treat multiple sclerosis, " said Professor Michel Revel, Israel Prize Winner, Kadimastem Founder and Chief Scientist, and famous for his groundbreaking research that led to the development of the blockbuster drug Rabif for multiple sclerosis.


Kadimastem CEO Asaf Shiloni said, “Expanding our R&D activity by conducting the ALS and the MS research in parallel enables us to provide maximum value for patients and investors alike. We are working diligently to move the ALS clinical program ahead. We also hope that AstroRx® will be the answer for the millions of MS patients for whom the usual method of treatment is ineffective. The use of AstroRx® cells, with their various mechanisms of action, may lead to an innovative regenerative treatment for the disease."


About AstroRx®

Kadimastem’s AstroRx® is manufactured under GMP manufacturing conditions and has FDA “orphan drug” status for the treatment of ALS. The product is comprised of astrocyte cells created from embryonic stem cells, expanded and differentiated using Kadimastem’s proprietary technology.

AstroRx® has shown to support the nerve cells in the central nervous system, including the brain and spinal cord. In the company’s first clinical trial, AstroRx® demonstrated safety and showed to delay the progression of ALS by three months.

Kadimastem intends to file an IND with the FDA by the end of 2022, with the goal of securing the agency’s approval to begin a Phase IIa, multicenter, clinical trial of AstroRx® in the US for the treatment of ALS.

Kadimatem also intends to explore the therapeutic effects of its astrocytes in treating various other indications including MS, as indicative by today’s announcement.

Multiple Sclerosis is a chronic, autoimmune disease of the nervous system, which impairs the proper functioning of the nerve cells in the central nervous system by damaging and reducing the myelin sheath. Myelin is a fatty substance that isolates nerve fibers (axons), thus allowing uninterrupted transmission of electrical currents between nerve cells. Impairment in the transmission of currents makes it difficult for the brain to function properly (which is based on the transmission of electrical currents), which affects the functioning of the entire body and causes many neurological symptoms.

AstroRx® may protect these nerve cells and the cells that produce the myelin, thus preserving their function. AstroRx® also has the potential in MS to support the damaged cells by releasing neurotrophic substances that protect nerve cells, lowering the amount of free radicals, regulating the immune system and eliminating toxic substances released in the pathological state.


About Kadimastem


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 Multiple Sclerosis.


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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Company Contacts:

Asaf Shiloni

CEO

s.bazak@kadimastem.com


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General Manager

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