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®, 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®. We see in this cell-based product high hopes for effective treatment of ALS, which damages motor neurons. AstroRx® 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®. 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®, 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.
Kadimastem (http://www.kadimastem.com) is a biotechnology company that develops industrial regenerative medicine therapies based on differentiated cells derived from Human Embryonic Stem Cells (hESCs) to treat neuro-degenerative diseases such as ALS, as well as diabetes. The company was founded in August 2009 by Professor Michel Revel and Yossi Ben Yosef, and is traded on the Tel Aviv Stock Exchange (TASE: KDST). The company's chairman is Dr. Eli Opper, formerly the Chief Scientist of the Israeli Ministry of Industry, Labor and Trade. The company's investors, in addition to the founders, include Altshuler Shaham Investment House, foreign investors (Julien Ruggieri and Avi Meizler), and additional institutional investors.
Kadimastem was founded based on patent protected technology that was developed at the Weizmann Institute of Science. Based on the company's unique platform, Kadimastem is developing two types of medical applications: A. Regenerative medicine, which repairs and replaces organs and tissue by using functioning cells differentiated from stem cells. The company focuses on transplanting healthy brain cells to support the survivability of nerve cells as cell therapy for ALS, and transplanting insulin-secreting pancreatic cells for the treatment of insulin-dependent diabetes; B. Drug screening platforms, which use functional human cells and tissues to discover new medicinal drugs. The company has two collaboration agreements with leading global pharmaceutical companies.
Kadimastem has an extensive scientific advisory board, featuring prominent scientists and pioneers: in the embryonic stem cells field, Professor Benjamin Reubinoff, Director of the Hadassah Human Embryonic Stem Cell Research Center and Senior Physician at the Department of Obstetrics and Gynecology at the Hadassah University Medical Center; Professor Joseph Itskovich, world renowned expert and pioneer in pluripotent stem cell research and former head of Obstetrics and Gynecology at RAMBAM Medical Center; in the neurodegenerative disease field, Professor Tamir Ben-Hur, Head of the Department of Obstetrics and Gynecology at Hadassah University Medical Center; and in the diabetes field, Professor Shimon Efrat, professor of Human Molecular Genetics and Juvenile Diabetes at Tel Aviv University and a world renowned expert in cell replacement therapy for diabetes and Professor Eddy Karnieli, former Director of the Institute for Endocrinology, Diabetes and Metabolism at the RAMBAM Medical Center, and a world renowned expert in these fields.
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