A new phase 3, registration trial has been announced by OncoGenex Pharmaceuticals, Inc. of its investigational drug custirsen sodium (OGX-011/TV-1011). The trial, for men with metastatic castrate resistant prostate cancer (mCRPC) is referred to as the Prostate Cancer SATURN Trial.

This randomized, controlled, trial will include approximately 50 cancer centers and is planned to enroll approximately 300 men with mCRPC who have previously responded to first-line docetaxel therapy, but subsequently have disease progression that involves prostate cancer-related pain despite opioid usage.

The subject men will be randomized to receive treatment with docetaxel/prednisone plus OGX-011/ TV-1011 or docetaxel/prednisone plus placebo in a blinded manner. The primary endpoint of this trial will be durable pain palliation for 12 weeks or more in the men treated with docetaxel/prednisone plus OGX-011/ TV-1011 compared to docetaxel/prednisone plus placebo.

The Principal Investigators for the SATURN trial are Dr. Tomasz Beer at the Oregon Health & Science University Knight Cancer Institute for the United States, Dr. Sebastien Hotte at Juravinski Cancer Centre in Hamilton, Ontario for Canada and Professor Karim Fizazi at the University of Paris for Europe.

This trial is moving forward based on the Phase 2 data in men with mCRPC who were treated with OGX-011/ TV-1011 in combination with docetaxel/prednisone treatment as second-line chemotherapy.

“Pain is a dominant symptom in patients with progressive prostate cancer and frequently remains a challenge despite treatment with opioid analgesics. Poorly controlled pain has devastating effects on both patients and their family members,” stated Dr. Beer. “In the Phase 2 trial, almost half of patients who had pain or were on opioids and were retreated with docetaxel/prednisone with the addition of OGX-011/ TV-1011 had durable pain palliation for 12 weeks or more. This is better than expected based on pain responses seen after initial treatment with docetaxel/prednisone.”

A separate Phase 2 trial evaluating OGX-011/ TV-1011 in combination with first-line chemotherapy showed that patients with advanced metastatic prostate cancer who were treated with OGX-011/ TV-1011 plus docetaxel had a median overall survival of 23.8 months compared to 16.9 months for patients treated with docetaxel alone — a 6.9 month observed survival advantage for the OGX-011/ TV-1011 arm.

Additionally, OGX-011/ TV-1011 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) and this SATURN trial is being conducted through the Special Protocol Assessment (SPA) process. Earlier this year, the European Medicines Agency indicated that the Committee for Medicinal Products for Human Use was in overall agreement with the company’s development plan for OGX-011/ TV-1011 which included this Phase 3 trial.

More information on the Prostate Cancer SATURN Trial is available on the Company’s website at .

Joel T Nowak MA, MSW