Protox plans to initiate phase I clinical trials of PRX302 early next year upon approval of the IND by the FDA. The trial is expected to enroll 18-24 patients and has been designed to determine safety, tolerability and therapeutic activity of PRX302.
“At present there are no licensed drugs available for salvage therapy of purely local recurrence of prostate cancer,” commented Dr Fahar Merchant, president and CEO of Protox.
PRX302 is a novel, first-in-class pore-forming prodrug that is activated by prostate specific antigen (PSA), an enzyme that is produced by, and only active in, the prostate.
The company plans to file an IND for PRX302B for the treatment of benign prostate hyperplasia in 2006.