PRX302

PRX302 is an inactive pro drug that is genetically engineered to be activated by an enzyme called prostate specific antigen (PSA). Once activated PRX302 is transformed into a powerful pore forming toxin that selectively kills cells that produce PSA. Most men with prostate cancer or benign prostatic hyperplasia (BPH) produce large amounts of active PSA at the diseased site and therefore PRX302 has the potential to treat both of these devastating conditions. BPH and localized prostate cancer affect millions of men worldwide and today there are no effective therapeutic agents with a good safety profile.

In April 2008, Protox received approvals from the Institutional Review Board (IRB) and Health Canada to proceed with a Phase 2 clinical trial evaluating PRX302 for the treatment of benign prostatic hyperplasia (BPH). Results released in November 2008 demonstrated a statistically significant improvement in International Prostate Symptom Scores (IPSS) (p>0.001) and Quality of Life (QoL) scores (p>0.0001), as well as a continued strong safety profile. A Phase 2b study is ongoing and top-line results are expected in Q4 2009.

Protox received clearance from the United States Food and Drug Administration (FDA) in January of 2006 to commence a Phase 1 open label, single arm dose escalation clinical study with PRX302 for patients with locally recurrent prostate cancer. That trial, completed in November 2007, demonstrated that PRX302 is safe and well tolerated and shows promising signs of therapeutic activity.