Kadimastem announced that it has received the approval of the Ministry of Health’s Supreme Committee, for conducting its phase I/IIa clinical trial in ALS patients using the unique cell therapy developed by the company.
NESS ZIONA, Israel, March 13, 2018 /PRNewswire/ -- Israeli biotechnology company Kadimastem (TASE: KDST) announced today that it has received the approval of the Ministry of Health’s Supreme Committee, for conducting its phase I/IIa clinical trial in ALS patients using the unique cell therapy developed by the company. With this approval, Kadimastem has obtained all the approvals required for its clinical trial, which will commence right away.
The clinical trial will be conducted by the Department of Neurology of the Hadassah Ein-Kerem Medical Center, a world-leading center in the field of ALS, and is expected to include 21 patients. Hadassah Medical Center is beginning to recruit the patients for the trial. The trial will be performed within a framework of the outline coordinated with the FDA. The company intends to initiate the clinical site in Hadassah Ein-Kerem within the next two weeks.
The treatment developed by the company, AstroRx(R), is a groundbreaking cell-based treatment for ALS, the result of unique research of the company over many years. Kadimastem developed a unique technological platform for the repair and replacement of tissue and organs, using functioning cells differentiated from pluripotent stem cells.
Yossi Ben-Yossef, CEO of Kadimastem, noted: “The vision before us, when Professor Revel and I founded the company, was to build a leading company in the cell therapy field, and to develop innovative, groundbreaking treatments to help millions of patients suffering from various diseases worldwide. Today, we are proud to announce the start of this vision turning into reality, with the receipt of the Ministry of Health’s approval for commencing our clinical trial in ALS.”
Ben-Yossef added: “The commencement of the clinical trial is the most significant event since the founding of the company. It is a great achievement for us, both in the company’s reaching the clinical stage, as well as in the successful development of a revolutionary, groundbreaking treatment, based on a unique approach in the cell-based medicine field, which demonstrated excellent preliminary results, attesting to the treatment’s efficacy and safety.”
Professor Michel Revel, the company’s Chief Scientist, said: “I am very happy the company had achieved this important milestone and received approval for the clinical trial in ALS patients with AstroRx(R). We see in this cell-based product high hopes for effective treatment of ALS, which damages motor neurons. AstroRx(R) is made up of young astrocytes, which are manufactured by the company from pluripotent stem cells, and which have shown high efficacy in protecting the survivability and functioning of motor neurons in ALS models. The benefit is that, for the first time, we’ll be able to offer the same product for the treatment of ALS patients worldwide. This is an important stage in the activities of Kadimastem and the fruit of the endeavors of our scientific and regulatory teams, who worked to successfully complete the development of the treatment. The company is now advancing to the clinical trial, which will be conducted with Hadassah Medical Center’s experts, and also plans to work on applying the same drug in additional neurological diseases.”
Professor Tamir Ben-Hur, Head of the Department of Neurology in Hadassah Medical Center in Jerusalem, added: “We are happy to be commencing the first-of-its-kind clinical trial using human embryonic stem cells for the treatment of ALS, an incurable neurodegenerative disease. We’re particularly proud that the cell based platform was developed and produced at Hadassah by Professor Benjamin Reubinoff and his team, now making its way into the clinical application thanks to its development as a drug by Kadimastem. There’s a robust scientific foundation for this trial and preliminary safety trials were conducted at an unprecedented scope. All of this gives way to optimism.”
Dr. Michal Izrael, the company’s VP R&D for ALS and Neurodegenerative Diseases, noted: “We are excited about receiving the approval for the treatment of incurable ALS patients using AstroRx(R). Kadimastem’s clinical trial is among the pioneers in the world, in its use of cell therapy derived from embryonic stem cells to treat a neurodegenerative disease. The company’s clinical product, AstroRx(R), is manufactured in the company’s production facilities, under GMP conditions, and has been proven effective and safe. The clinical trial will be accompanied by a skilled medical team from Hadassah Ein-Kerem Medical Center and monitored by international clinical trial management company CATO Research. Within the next two weeks, the company intends to initiate the clinical site at Hadassah Ein Kerem, in order to facilitate the commencement of the clinical trial.”
Kadimastem’s innovative approach is based on research showing that in ALS patients, brain-supporting cells (astrocytes) are malfunctioning and fail to properly support motor neurons. The company’s technology enables the production of healthy supporting cells and their injection into the patient’s spinal fluid (using a standard procedure) with the goal of supporting the malfunctioning cells in the brain, slowing the progression of the disease and improving the patient’s life quality and expectancy.
Kadimastem’s technology enables large-scale production of the cells under GMP conditions and as an off-the-shelf product which will enable the treatment of large ALS patient populations.
