Aldoxorubicin: Phase IIb started
CytRx began an open-label, international Phase IIb trial to compare 230 mg/m 2 IV aldoxorubicin given on day 1 of a 21-day cycle vs. IV Hycamtin topotecan in about 132 patients with SCLC who have relapsed or were refractory to prior chemotherapy. Patients in the Hycamtin arm will receive a 1.5 mg/m 2 dose for 5 consecutive days starting on day 1 of a 21-day cycle or a 4 mg/m 2 dose on days 1, 8 and 15 of a 28-day cycle.
FDA also granted Orphan Drug designation to aldoxorubicin for glioblastoma multiforme (GBM), SCLC and ovarian cancer. Aldoxorubicin is in Phase III testing for second-line treatment of soft tissue sarcoma (STS) and Phase II testing to treat GBM and HIV-related Kaposi's sarcoma. Top-line Phase II data in GBM and Kaposi's sarcoma are expected next half. The product has Orphan Drug designation in the U.S. and EU for STS and in the U.S. for pancreatic cancer. ...