Kadimastem Holds Successful Preliminary Meeting with the FDA (INTERACT) Regarding IsletRx for the Treatment of Diabetes
Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing cell therapy treatments for ALS and diabetes, announced today that the Company held a preliminary meeting with the FDA (INTERACT) on October 7, 2021 regarding IsletRx, the company’s cell therapy product in development for the treatment of diabetes.
During the meeting, Kadimastem received a response document from the FDA noting that the company’s clinical development plan for IsletRx was being positively considered. It also included constructive comments and guidelines applicable for the next step pre-IND submission.
This interaction is of great importance to Kadimastem’s clinical product development process and is an important milestone for the company. It was Kadimastem’s first meeting with the FDA regarding its diabetes project and the FDA’s first review of IsletRx, which demonstrated positive results in preclinical trials.
IsletRx is an expanded population of allogeneic stem cells differentiated into functioning insulin producing pancreatic islet cells. The company then uses a proprietary technology to select the purest performing cells from its population and puts them into a microcapsule that protects the cells from being rejected by the body’s immune system. The implanted cells have shown in preclinical studies to be able to detect the sugar levels in the body and to, produce, and secrete, on demand, the required amounts of insulin and glucagon, just like a healthy pancreas.
Kadimastem CEO Asaf Shiloni said, "Thanks to Dr. Kfir Molakandov, the Director of Diabetes at Kadimastem, who presented the IsletRx project in an impressive manner, we received a positive response to the company’s clinical development outline from the FDA's expert team, who we believe were overall very impressed with our technology. The FDA’s expert team provided us with important feedback that we will use to prepare for the next step, our Pre-IND submission for IsletRx. I am convinced that the successful meeting and the relevant feedback will contribute to the continued progress of our product development and if all goes well, ultimately provide a cure for those living with diabetes.”
Kadimastem Chief Scientist Professor Michel Revel said, “The INTERACT meeting with the FDA is an important step forward and shows that Kadimastem's development plan for its diabetes treatment product, IsletRx, is in the right direction.”
Kadimastem is a clinical stage cell therapy company, developing and manufacturing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development as a treatment for ALS. IsletRx is the company's second product in development. IsletRx is comprised of functional pancreatic islet cells intended to cure patients with insulin dependent diabetes. IsletRx demonstrated safety and efficacy in a proof-of-concept preclinical study. An INTERACT meeting took place with the FDA on October 7, 2021 where the diabetes treatment program was discussed and the company received directions how to prepare its Pre-IND submission. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold 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 consider that past performance does not necessarily indicate performance in the future.
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