ProstVac: Interim Phase II data

Interim data from a Phase II trial in 34 evaluable CRPC patients with bone metastases who were previously treated with docetaxel showed that ProstVac in combination with Quadramet led to a PFS rate at 4 months, the primary endpoint, of 29.4% vs. 11.8% for Quadramet alone. Median PFS was 117 days for ProstVac plus Quadramet vs. 60 days for Quadramet alone. Additionally, 4 of 17 patients receiving ProstVac plus Quadramet achieved a >=30% reduction in PSA, while 2 achieved a reduction of >=50%. No patient receiving Quadramet alone (n=17) achieved a >=30% PSA reduction. ProstVac plus Quadramet was well tolerated with a similar toxicity profile to that of Quadramet alone. The trial plans to enroll 68 patients to receive 1 mCi/kg IV Quadramet on day 8 and then every 12 weeks with or without ProstVac given on days 1, 15 and 29 and then every 4 weeks. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...