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This is the first of a three-step process, with the goal of designing and commencing an FDA-approved clinical study of iTOL-102. The second step would be to submit a pre-IND application based on the feedback from the INTERACT meeting, followed by an IND application to begin clinical trials at locations worldwide.
In
The purpose of the meeting would be to present the iTOL-102 development program and specifically discuss the chemistry, manufacturing and control (CMC) program, the definitive proof of concept study design in light of preliminary data, and general plans for non-clinical safety and clinical development. The parties intend to continue the development of the product and are even considering expanding the cooperation, for the benefit of product development, including through the establishment of a joint company in
IsletRx is comprised of clinical-grade clusters of human pancreatic islet like cells (ILCs) with the ability to secrete insulin. IsletRx cells can detect the sugar levels in the body and produce the required amounts of insulin and glucagon, iTolerance will provide its platform technology (iTOL-100) intended to enable the transplantation of allogeneic cells without tissue matching and without the need for chronic treatments that suppress the immune system of the transplant recipient (immunosuppression).
Dr.
At
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 Kadimastem’s or iTolerance’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the companies' activity, as well as developments in the general environment and external factors affecting the companies' activity. The companies’ results and achievements in the future may differ materially from any presented herein and the companies make no undertaking to update or revise such projection or estimate and do not undertake to update this document. This document does not constitute a proposal to purchase the companies' securities or an invitation to receive such offers. Investment in securities in general and in the companies in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.
Contact Details
+972 73-797-1613
s.bazak@kadimastem.com
iTolerance
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+1 202-779-0929
sr@roberts-communications.com
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https://www.kadimastem.com/
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