Early Clinical Experience - Safety, Tolerance, Pharmacokinetics, and Imaging Properties

The safety and efficacy of N1177-sq has been studied in normal human subjects, adult males and females, and in breast cancer patients, adult females.  In the Phase 1 program, three different clinical trials have been conducted to evaluate the safety, tolerance, pharmacokinetics, and imaging properties of several doses of N1177 when administered subcutaneously to healthy adult male and female subjects. Each subject was monitored before and for varying lengths of time (up to 100 days) after the administration of N1177 for signs of adverse tolerance to the material. Safety evaluation included a complete battery of blood chemistry tests, 12-lead electrocardiogram, physical examinations, vital sign measurements, and questioning the subject. CT scans of lymphatics draining the site of injection (feet, thigh or anterior chest wall) were obtained up to 24 hours after injection. No clinically significant change requiring intervention was noted in any laboratory test value, vital sign measurement, or electrocardiographic interval. CT scans obtained after the injection of N1177 indicated a generally dose-related increase in lymphatic node enhancement. Over time, sequential nodes in the basin/chain were enhanced, indicating node-to-node transfer of N1177. These data support NSI’s hypothesis that N1177 has the potential to offer a safe and accurate, noninvasive assessment of the lymph nodes regional to various carcinomas.