- Clinical Trials
A phase I 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 I trial was to assess the toxicity of REQORSA administered intravenously and to determine the maximum tolerated dose, or MTD, and recommended Phase II 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.