Technology evaluation: CV-787, Calydon Inc.

CV-787 is a recombinant adenovirus that replicates only in prostate-specific antigen (PSA)-producing cells, which is being developed by Calydon Inc for the treatment of prostate cancer [339621]. This attenuated replication-competent virus (ARCA) only replicates in and destroys PSA-producing cells. By engineering the prostate-specific enhancer (PSE) control element into the adenovirus, Calydon has established both a means for delivery and the mechanism for killing prostate cancer cells [339621]. In October 1999, Calydon began treating patients with biopsy-proven, prostate-confined cancer with CV-787 in a phase I/II multi-center, open-label, dose-finding study [362188], [344731]. In September 2000, Calydon initiated a a phase I/II multi-center, open-label, dose-finding trial of an intravenous formulation of CV-787 in men with metastatic prostate cancer [384039]. The trial was designed to enrol 48, and enrollment was continuing in April 2001. The study is being conducted at three medical centers: University of California at San Francisco; Johns Hopkins Oncology Center in Baltimore; and, University of Wisconsin at Madison. The primary objectives of this trial are to determine the safety, tolerability, and PSA efficacy of CV-787 administered intravenously to patients with end-stage prostate cancer [384039].