Kadimastem Announces the Completion of Cell Transplantation of AstroRx® in ALS Patients for Cohort A in Phase I/IIa of Its Clinical Trial

Wednesday, February 27, 2019 Clinical Trials News
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NESS ZIONA, Israel, Feb. 27, 2019 /PRNewswire/ -- Israeli biotechnology company Kadimastem

(TASE: KDST) announced the completion of cell transplantation (AstroRx®) in 5 patients who were enrolled in Cohort A for its clinical trial in ALS.

In preparation for this stage of the clinical trial the company has recently hired a production

manager with many years of experience in the field of clinical production. The company has also upgraded the production system, increased its QA and production teams, and invested considerable resources in improving the production process.

The phase I/IIa clinical trial is being conducted by the Department of Neurology of the Hadassah Ein-Kerem Medical Center, and it is expected to include a total of 21 patients. The objective of the trial is to evaluate the safety and efficacy of AstroRx® in patients. Results for Cohort A of the trial are expected within around half a year. The company is prepared for the next cohort of patients and is expecting to receive MOH approval by April 2019.

AstroRx® contains functional healthy astrocytes (nervous system support cells) derived from human embryonic stem cells that aim to protect ALS-diseased motor neurons through several mechanisms. The company's technology enables the injection of AstroRx® cells into the patient's spinal fluid with the goal of supporting the malfunctioning cells in the brain and spinal cord, slowing the progression of the disease and improving the patient's quality of life and life expectancy.

Mr. Yossi Ben-Yosef, CEO of the company said: "I am proud of the professional and dedicated work of the Kadimastem team. Providing treatment to 5 patients is an important milestone in the progress of the trial. A great deal of effort has been invested in reaching this point and we are looking forward to continuing to provide treatment to additional patients."

Prof. Michel Revel, Kadimastem's Chief Scientist commented: "I am pleased with the progress of the clinical trial thanks to the professional organization of the drug production system in the company's clean rooms. The continued data collection of neurologic data in ALS patients before and after treatment will allow us in the near future to evaluate the results of the first group of patients."

About AstroRx®

AstroRx®is an innovative cell-based treatment for ALS, which consists of brain supporting cells (astrocytes), designed to replace the astrocytes whose functionality was damaged in ALS patients. AstroRx® is manufactured by Kadimastem from pluripotent stem cells using a unique technology developed by the company. Currently, there are only two FDA-approved drugs for the treatment of ALS, and they are only able to slightly slow down the progression of the disease. The advantage of AstroRx® is in replacing the patient's malfunctioning astrocytes with healthy cells. AstroRx® has several mechanisms of action protecting the damaged motor neurons simultaneously, as opposed to currently available treatments which use a single mechanism. The unique properties of AstroRx® are expected to significantly slow down the progression of the disease, as demonstrated by the company in its pre-clinical trials.

About Kadimastem

Kadimastem (www.kadimastem.com) is a clinical stage 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 technology for 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.

Kadimastem has an extensive scientific advisory board, featuring prominent scientists and pioneers: in the embryonic stem cells field, - Professor Joseph Itskovitz-Eldor, a world renowned expert and pioneer in pluripotent stem cell research and former head of Obstetrics and Gynecology at Rambam Medical Center, serves both as a director and a senior strategic consultant in the company, and Prof. Benjamin Reubinoff, head of Department of Obstetrics and Gynecology at the Hadassah University Medical Center and director of the Hadassah Human Embryonic Stem Cell Research 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.

Contact: Sarah HerzlTel: +972-73-7971613Email: s.herzl@kadimastem.com

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SOURCE Kadimastem



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