A 10% Rose Bengal in saline solution (PV-10) can elicit selective ablation of solid tumors upon intralesional injection. Interim safety and efficacy data were presented for 40 subjects with stage III or IV melanomas after an initial treatment of 1-20 lesions. The primary endpoint was objective response (OR) of injected lesions; secondary endpoints included OR of bystander lesions. Transient locoregional pain was reported by 60% of patients; vesicles (30%); edema (28%); and local swelling (18%). Grade III adverse events were rare. Interim efficacy data on the first 20 patients indicated a complete response in 30% and partial response in 30%. These results were similar to those seen in phase I studies ...