The investigational new drug (IND) application for PRX302 was filed in December 2005. PRX302 is the first of a novel class of targeted prodrugs based on the company’s PORxin platform. It is a therapeutic pore-forming toxin designed to be activated by prostate specific antigen (PSA), an enzyme that is produced and is active only in the prostate.
The phase I clinical trial will be an open-label, dose-escalation study of PRX302 in patients with locally recurrent prostate cancer. The trial is expected to enroll approximately 24 patients and has been designed to determine safety, tolerability and therapeutic activity of PRX302.
“Receiving FDA approval to proceed with our first phase I clinical trial is a significant and exciting milestone for the growth of Protox and its clinical development programme,” stated Dr Fahar Merchant, president and CEO of Protox. “This milestone underscores the potential therapeutic benefit of our targeted PORxin platform.”
Dr Merchant went on to say that the company plans to submit an additional IND later in the year for the drug in an indication to treat benign prostatic hyperplasia, or enlarged prostate.