PRIMA-1MET: Additional Phase I/II data

Additional data from an open-label, Swedish Phase I/II trial in 22 patients with refractory hematologic malignancies or prostate cancer showed that once-daily doses of up to 90 mg/kg IV APR-246 for 4 consecutive days were well tolerated with fatigue, dizziness, headache and confusion reported as the most common adverse events. The MTD was 60 mg/kg APR-246. Additionally, 1 patient with acute myelogenous leukemia (AML) achieved a 50% reduction in the number of blast cells in the bone marrow and 1 patient with non-Hodgkin's lymphoma (NHL) had a minor response on a CT scan. Data were published in the Journal of Clinical Oncology. ...