Kadimastem, an early-stage cell therapy company announced successful results of a preclinical study of an “off-the-shelf” cell product for the treatment of insulin-dependent diabetes.
The product, called IsletRx, is comprised of highly purified functional human pancreatic islet cells integrated with a microencapsulation technology developed by the company.
Kadimastem 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, which lasted 3 months.
Furthermore, the company reported no disease or treatment-related complications were observed, and all treated animals remained healthy throughout the 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 the host immune system response, without the need for potentially toxic immunosuppressive drug treatment.
Based on these results, Kadimastem continues to advance its IsletRx development program towards the clinical stage.
The company plans to have discussions with the U.S. Food and Drug Administration (FDA) during the first quarter of 2020.
Additional pre-clinical studies will be required, with results expected during 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.
“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 Kadimastem, stated.
“We are excited by this significant progress, as we further develop our ability to provide treatment to millions of Insulin-Dependent Diabetes patients,” he added.
- Kadimastem Ltd. (2019, Nov. 20). Kadimastem Announces Successful Preclinical Results of Its Cell Therapy Treatment for Insulin-dependent Diabetes. PR Newswire. Retrieved Nov. 20, 2o19 from https://prnmedia.prnewswire.com/news-releases/kadimastem-announces-successful-preclinical-results-of-its-cell-therapy-treatment-for-insulin-dependent-diabetes-300960989.html