The National Cancer Institute (NCI), under the Cancer Treatment Research Federal Grant Program (CFDA 93.395), awarded Enclear Therapies Inc. a $295,851 Project Grant on July 1, 2024. The purpose of this Phase 1 grant is to demonstrate the safety and feasibility of optimally delivering the chemotherapy drug topotecan to the cerebrospinal fluid (CSF) in a large animal model. The key products and services to be delivered include: 1) further development and optimization of a preclinical CSF extracorporeal flow system for subarachnoid chemotherapy delivery, 2) bench-top testing of the preclinical system, and 3) demonstration of the feasibility and safety of the Enclear preclinical delivery system in a minipig glioma tumor model with topotecan treatment. This work is intended to lead to the final device development, design verification, expanded animal efficacy studies, GLP safety testing, and ultimately an Investigational Device Exemption application to the FDA for a first-in-human study.
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