Kadimastem 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.
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"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,” Prof. Michel Revel, Founder and CSO of the Company, said. “We are excited by this significant progress, as we further develop our ability to provide treatment to millions of Insulin-Dependent Diabetes patients."
"The IsletRx product targets a multi-billion dollar market, which currently offers only repeated daily insulin injections,” Rami Epstein, CEO of the Company, said. “This achievement is an additional validation of our scientific and technological capabilities, positioning us in the forefront of the cell therapy industry."
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.