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Isis Announces That OGX-011 Has Shown Overall Survival Advantage in Prostate Cancer Compared to Standard Therapy in a Randomized Phase 2 Study
Date:12/3/2008

dian survival for the OGX-011 arm can be reported. Based on the current results, OncoGenex has calculated that the final median survival for patients in the OGX-011 arm cannot be lower than 22.7 months. The trial was conducted and data were analyzed by the National Cancer Institute of Canada, Clinical Trials Group and was supported by a grant from the NCI-Canada with funding from the Canadian Cancer Society. For further details on the study, please see OncoGenex' release that was issued today, December 3, 2008.

ABOUT OGX-011

OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with treatment resistance and is currently being evaluated in Phase 2 clinical studies in prostate, lung and breast cancer. It has received Fast Track designation from the U.S. Food & Drug Administration (FDA) in combination with docetaxel for progressive metastatic prostate cancer. Recently, the FDA confirmed the appropriateness of durable pain palliation as a primary endpoint for product marketing approval for OGX-011 as a treatment for hormone refractory prostate cancer. Earlier this year at ASCO, OncoGenex reported OGX-011 Phase 2 data showing better than expected survival results in combination with chemotherapy, reduction in levels of clusterin, durable reductions in pain, and a decline in PSA, a protein that is often elevated in patients with prostate cancer.

OGX-011 was jointly discovered by Isis and OncoGenex and until July 2, 2008 was co-developed by Isis and OncoGenex. OncoGenex is now responsible for all development costs and activities of OGX-011. Isis will receive royalties for OGX-011 ranging from 5.5% to 7% of net sales. In addition, OncoGenex will pay Isis 30% of the upfront fees and milestone payments OncoGenex receives if OncoGenex licenses OGX-011 prior to initiation of registration trials, 25% if OGX-011 is licensed before 20% of patients have been enrolled in a
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SOURCE Isis Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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