NESS ZIONA, Israel, Nov. 19, 2019 /PRNewswire/ — Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company, today announced successful results of its preclinical proof-of-concept study of IsletRx, an “off-the-shelf” cell product for the treatment of Insulin Dependent Diabetes. IsletRx is comprised of highly purified functional human pancreatic islet cells integrated with a microencapsulation technology developed by the Company.
The Company reports that study objectives have been achieved, as study results show safe delivery of IsletRx and demonstrate efficacy manifested by prolonged normalized blood sugar levels in treated immunocompetent diabetic mice throughout the duration of the preclinical study (3 months). Furthermore, no disease or treatment related complications were observed, and all treated animals remained healthy throughout study duration. In comparison, a control group of non-treated diabetic mice presented severe hyperglycemia, leading to the death of the non-treated mice within 40 days.
The unique microencapsulation technology, integrated within the IsletRx, protected the islet cells from host immune system response, without the need for potentially toxic immunosuppressive drug treatment.
Based on these results, the Company continues to advance its IsletRx development program towards the clinical stage. The Company plans to engage in discussions with the U.S. Food and Drug Administration (FDA) during H1 2020. The Company estimates that additional pre-clinical studies will be required, with results expected during H1 2021. These results will support further discussions with the FDA regarding an Investigational New Drug (IND) application later that year, in order to advance IsletRx to the clinical stage.
Prof. Michel Revel, Founder and CSO of the Company, stated “Not only do these results demonstrate the high quality of our cells but also our ability to overcome major challenges faced by the cell therapy industry, the delivery method of cells and the need to protect them from the host immune system without the requirement for immunosuppressive drugs. We are excited by this significant progress, as we further develop our ability to provide treatment to millions of Insulin-Dependent Diabetes patients.”
Rami Epstein, CEO of the Company, added: “The IsletRx product targets a multi-billion dollar market, which currently offers only repeated daily insulin injections. This achievement is an additional validation of our scientific and technological capabilities, positioning us in the forefront of the cell therapy industry.“
About Insulin-Dependent Diabetes
Diabetes is one of the 21st century’s largest global health epidemics. It is a chronic disease characterized by high blood sugar levels and sugar intolerance due to insulin deficiency, impaired insulin effectiveness or both. Diabetes complications include cardiovascular diseases, kidney failure, and neuropathies, and increase the risk of serious vision disorders, such as cataracts and glaucoma. According to the International Diabetes Federation (IDF), in 2017 there were 424.9 Million people who suffered from diabetes and by 2045, the number is expected to increase to 628.6 Million. The American Diabetes Association (ADA) estimates the annual costs of diabetes patients in the US alone at $223.5 Billion. The global costs are estimated at $465 Billion and expected to reach $510 Billion by 2030.
Two types of diabetes, type 1 and type 2, are different in their causes and clinical representation. All type 1 diabetes and 30% of type 2 diabetes patients depend on the administration of insulin for managing their glucose levels in the blood. According to Prescient & Strategic (P&S) Intelligence Private Limited market report (2018), the global human insulin market was valued at $42.9 Billion in 2017 and is projected to register a CAGR of 8.8% to reach $70.6 Billion in 2023.
IsletRx is cellular product developed and manufactured by the Company based on its proprietary Technology Platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into clinical grade functional cells for the treatment of multiple diseases. IsletRx contains pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels. IsletRx is produced utilizing proprietary method of the Company, which includes a unique stage for functionally active cells using newly specific cell surface biomarkers. In addition, a unique microencapsulation technology, integrated within IsletRx, protects the islet cells from the host immune system, thus allowing prolonged therapeutic effect. IsletRx is intended for the treatment of Insulin Dependent Diabetes, aiming to free patients from continuous monitoring of blood sugar levels and repeated insulin injections.
Kadimastem is a clinical stage cell therapy company, developing and manufacturing “off-the-shelf” allogeneic proprietary cell products based on its platform technology for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into clinical grade functional cells. AstroRx®, the Company’s lead program, is a clinical-grade astrocyte cell therapy for the treatment of ALS, currently undergoing a Phase 1/2a clinical trial. In addition, preclinical trials are ongoing with the Company’s IsletRx pancreatic functional islet cells for the treatment of insulin dependent diabetes. Kadimastem was founded by Prof. Michel Revel, CSO of the Company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Prof. Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug with annual sales of billions of dollars worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
Forward Looking Statement
This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company’s activity, as well as developments in the general environment and external factors affecting the Company’s activity. The Company’s results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company’s securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular, bears risks. One should take into account that past performance does not necessarily indicate performance in the future.
Yossi Nizhar, CFO
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