Kadimastem - Stem Cell to Cure Diseases

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Following successful first stage in trial: Kadimastem Signed Agreement with Medical Device Company to Expand Joint Trials of Diabetes Therapy using Unique Encapsulation Device Joint Feasibility Trial on Animals to Start Next Month

Aug. 18, 2016

Ness Ziona, Israel, August 18, 2016 – Israeli biotechnology company Kadimastem (TASE: KDST) announced today that following success in the first stage of trials held under the agreement entered on November 24, 2015, an addendum was signed which sets out the timetable for starting feasibility studies in animals in the course of next month.

The first stage involved joint trials in which optimization of the conditions was carried out and it was shown that the insulin-secreting cells developed by Kadimastem demonstrate activity which is similar to human pancreatic islet cells. The purpose of that stage of the trial was to evaluate the oxygen consumption level of Kadimastem's cell-based product for the treatment of diabetes, in order to adapt it to the unique encapsulation technology that allows oxygen supply to the implanted device.

The innovative product will be a combination of the advanced technological capabilities of Kadimastem in developing medical solutions from embryonic stem cells for cell-based therapy of diabetes, with of the encapsulation technology. The use of the encapsulation device allows implanting the cells in compliance with the regulation and ensuring readily-available oxygen supply, saving the patients the need for prolonged therapy for suppressing the rejection of the implant by the immune system and thus ensuring the cells' long term survival and functioning. The device also facilitates the removal of cells from the body when necessary. This combination is expected to accelerate the development of the cell-based therapy for diabetes with Kadimastem's insulin-generating cells, cutting the time to the clinical trials.

Prof. Eddy Karnieli, former president of the Israel Endocrine Society, commented, "These trials will test the ability of Kadimastem's cells to exist in the encapsulation device and may prove to be a pivotal and critical turning point in the evolution from in vitro to in vivo trials in an animal diabetic model and in the future to clinical implementation in humans."

Prof. Michel Revel, the company's Chief Scientist, explained, "Along with the encapsulation technology, we hope to develop a unique technology that combines Kadimastem's capability of using pluripotent stem cells for large-scale production of diabetes-treating cells with a device that ensures the cells' survival and functioning. This combination promises an excellent implantation method for treatment of diabetes."

Yossi Ben-Yosef, CEO of Kadimastem, added, "Kadimastem puts strong emphasis on the need to protect the cells it produces following their implantation. The animal trials with the unique encapsulation devices will allow us to improve our ability to ensure the survival and functioning of Kadimastem's insulin-secreting cells in future clinical trials."

About diabetes

Diabetes is a chronic condition characterized by high blood sugar level and sugar intolerance due to shortage of insulin in the body, ineffective insulin secretion or both. There are two main types of diabetes, which differ in terms of the cause and clinical representation of the disorder: Type I and Type II diabetes. The number of diabetic patients in the world was estimated at over 422 million people in 2015 and is expected to grow to over 552 million by 2030. The American Diabetes Association (ADA) estimates that the total cost of diabetic patients is $223.5 billion a year in the USA alone. The global cost is estimated at $465 billion a year and is expected to reach $510 billion a year by 2030.

About Kadimastem

Kadimastem (www.kadimastemcom) is a biotechnology company that specializes in the development of human stem cell-based medical solutions for the treatment of diabetes and neurodegenerative diseases, such as ALS and Multiple Sclerosis. 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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For more information contact Noam Yellin at 972-54-424-6720; Iris Lubitch at 972-54 -252-8007


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