Ness Ziona, Israel, May 30, 2022 --- Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS, exploring one for multiple sclerosis and developing a potential cure for diabetes, has received a patent from the Japan Patent Office for AstroRx® for the treatment of ALS and drug screening. The patent also protects AstroRx® for the treatment of multiple sclerosis.
Caption: Astrocyte Cells
AstroRx® is comprised of a differentiated cell population of human astrocytes derived from human pluripotent stem cells. The cells are intended to support the central nervous system (brain and spinal cord), impaired by neurological diseases such as ALS and multiple sclerosis, which disrupt voluntary muscle movement.
In a first of its kind Phase I/IIa clinical trial, healthy and functioning astrocyte cells (AstroRx®) were injected into the spinal cord fluid of 10 ALS patients in a standard lumbar puncture. Data showed that AstroRx® delayed the progression of ALS by three months in ALSFRS-R measurement in both tested AstroRx doses.
In the next clinical trial of AstroRx®, the plan is to test if this three-month effect can be prolonged with repeated doses every three months of the off-shelf product of AstroRx®. Kadimastem remains on track to submit an 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.
Kadimastem CEO Asaf Shiloni said, “The Japanese patent strengthens our intellectual property and gives our cell therapy products top priority in the very important and large Southeast Asian region of the world. In addition, we are exploring the possibilities of business partnerships with the pharmaceutical industry in Japan, both for AstroRx® for ALS and IsletRx for diabetes.”
Kadimastem Chief Scientist Professor Michel Revel said, "Japan is a prominent territory. This patent protects a significant and highly unique technology and provides a solid IP advantage for Kadimastem."
The Japanese market is one of the most significant for stem cell-derived cell therapies. Japan has strategic importance in this field, as it is at the forefront of the international community supporting innovation and the development of products in the field of cell therapy. In November 2014, the Japanese Parliament approved a special law to facilitate clinical trials in the field of cellular medicine, with the aim of expediting approvals of intracellular therapies and quickly bringing them to market. Japan has more than 12,000 ALS patients and this number continues to increase as the population ages. The treatment of these patients is currently estimated at an annual $ 1 billion.
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 is being explored as a treatment for 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.
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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