TOPIC 399 LOCALIZED TREATMENT OF SOLID TUMORS WITH RADIATION TRIGGERED LIPOSOMES.

Rejuvenics Technologies is developing a patented technology that utilizes localized ionizing radiation to trigger release of chemotherapeutic agents encapsulated inside radio-sensitive liposomes. This first-of-its- kind methodology simultaneously targets radiotherapy and delivery of chemotherapeutics to solid tumors; minimizing toxic exposure to vital organs and potentially enhancing efficacy. In this Phase I proposal, Rejuvenics will develop encapsulated chemotherapy Radiation-Triggered Liposomes (RTLs), through three Objectives in collaboration with experts at the University of Arkansas for Medical Sciences: 1) Select the lead chemotherapeutic to encapsulate in RTL001 and characterize the radiation dose response of RTL001; 2) Determine biodistribution and pharmacokinetics of RTL001 in mice; and 3) Assess localized anti-tumor efficacy of RTL001 in mice. These results represent key pre-clinical milestones important to the FDA Pre-Submission process as Rejuvenics prepares for Phase II studies. We endeavor to demonstrate the ability of RTLs to achieve safer, controlled delivery of chemotherapy to treat non-metastatic lung cancer, overcome systemic toxicity, and improve clinical outcomes for millions of cancer patients. Rejuvenics' team of cancer, drug development and radiation researchers and industry experts is prepared to successfully execute this study, deliver tangible results to the NIH, and advance the product development toward clinical testing along the path to commercialization.