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OncoGenex Pharmaceuticals Announces Initiation of a Phase 3 Trial in Men with Metastatic Prostate Cancer
Date:6/21/2010

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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. An Investigator meeting was held in May to train and initiate US and Canadian sites. The Company expects to initiate European sites in the third quarter of 2010.

The SATURN trial design is based on the Phase 2 data in patients with metastatic CRPC who were treated with OGX-011/ TV-1011 in combination with docetaxel/prednisone retreatment 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
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SOURCE OncoGenex Pharmaceuticals, Inc.
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