Kadimastem Expands R&D Program to Include Multiple Sclerosis
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.
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."
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.