SCIB1: Updated Phase I/II data

Updated data from 16 patients with fully resected stage III/IV metastatic melanoma in an open-label, U.K. Phase I/II trial showed that SCIB1 led to a median survival of 26 months from study entry. Four patients showed evidence of disease progression. The Phase II portion is evaluating SCIB1 given at weeks 0, 3, 6, 12 and 24. The trial also includes an extension phase in which patients can receive SCIB1 every 3-6 months for up to 5 years. Scancell reported initial data from the Phase II portion last year and updated data in July (see BioCentury, Jan. 13 & July 21). The Phase II portion of the trial is also enrolling an 8 mg SCIB1 cohort of up to 13 patients.

Updated data from the Phase I portion of the trial showed that in patients who received >=3 doses of 2 or 4 mg SCIB1, median survival is 34 months from study entry. SCIB1 led to 1-, 2- and 3-year survival rates of 100%, 67% and 50%, respectively. In patients with stage IV disease who received 8 mg SCIB1, median survival is 13 months from study entry. ...