Kadimastem Announces the Enrollment of the First Patient for Its Clinical Trial in ALS Patients

NESS ZIONA, Israel I April 26, 2018 I Israeli biotechnology company Kadimastem (TASE: KDST) announced today the enrollment of the first patient for its clinical trial in ALS patients, using the cell therapy product developed by the company, AstroRx®.

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 21 patients.

The objective of the trial is to evaluate the safety and efficacy of AstroRx® in patients.

Interim results of the trial are expected within the coming year.

Professor Michel Revel, the company's Chief Scientist, said: "Kadimastem's commencement of the clinical trial in ALS, according to the clinical protocol, is a significant milestone in the company's clinical program. Thanks to the full cooperation provided by the physicians responsible for the trial at the Department of Neurology of the Hadassah Medical Center and the teams involved in the trial, the quick enrollment of the first patient was made possible. We strongly believe in the success of the trial according to the set timeframe, for the benefit of the patients."

Yossi Ben-Yossef, CEO of Kadimastem, added: "After obtaining the approval of the Ministry of Health for the AstroRx® clinical trial in ALS patients, Kadimastem quickly organized for the commencement of the trial.  I hope and believe that AstroRx® will likely improve the condition of the patients participating in the trial. In recent years, the cell therapy field has greatly accelerated globally. With the commencement of the clinical trial, Kadimastem joins a select group of biotechnology companies worldwide, that have the know-how and technological capability to bring advanced treatments based on pluripotent stem cells to the clinical trial stage. I believe that the advancement of the clinical program will significantly reinforce Kadimastem and position it as a leading company in the cell therapy field."

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 asDiabetes. 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 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.

SOURCE: Kadimastem

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