- Clinical Trials
A Phase 1 dose escalation trial was conducted at The University of Texas MD Anderson Cancer Center evaluating intravenous REQORSA™ (TUSC2/FUS1) monotherapy in stage IV recurrent, metastatic lung cancer patients. The primary objective of this Phase 1 trial was to assess the toxicity of REQORSA administered intravenously and to determine the maximum tolerated dose, or MTD, and recommended Phase 2 dose of REQORSA alone.
The study showed for the first time that a tumor suppressor gene can be delivered intravenously and selectively to a patient’s cancer cells using a systemic nanovesicle vector. Although this trial was not designed to show changes in outcomes, a halt in cancer growth was observed in a number of patients. REQORSA was well tolerated with tumor responses noted in lung primary and metastatic cancers in the liver, pancreas, and lymph nodes. In addition, pre- and post-treatment patient biopsies demonstrated that intravenous REQORSA selectively and preferentially targeted patients’ cancer cells.