Mental HealthOncoGenex Pharmaceuticals Announces Release Of Two ASCO Abstracts
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced the release of two abstracts to be presented during oral presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. Abstracts are now available to the public online on the OncoGenex Web site at http://www.oncogenex.com in addition to the ASCO Web site, http://www.abstract.asco.org.
Highlights from the OGX-011 Abstract
At the time data was submitted to ASCO and as previously disclosed in December 2008, the preliminary median overall survival in patients with advanced prostate cancer who were treated with OGX-011 plus docetaxel in a randomized Phase 2 trial was 27.5 months compared to 16.9 months for patients treated with docetaxel alone. The hazard ratio (HR), a measure used to determine the difference in survival between treatment groups, was 0.60, representing a 40% reduction in the rate of death for patients treated with OGX-011. New data disclosed today include a prospectively defined multivariate analysis evaluating variables predictive of overall survival. The analysis defined only three variables predictive of overall survival: performance status, presence of visceral metastasis and assignment to the OGX-011 treatment arm. Based on the multivariate analysis, patients treated with OGX-011 had a rate of death 46% lower than patients treated with docetaxel alone (HR=0.54; p=0.04).
The abstract represents survival data as of November 2008. Final survival data as of April 2009 for this trial will be presented during an oral presentation at ASCO.
Highlights from the OGX-427 Abstract
At the time the data was submitted to ASCO, 34 patients with a variety of cancers had been treated with OGX-427 as a single agent in a dose escalation Phase 1 trial. OGX-427 was well tolerated. Declines in circulating tumor cells (CTCs), an emerging metric to assess treatment effect, have been observed at all dose levels. Changes in tumor markers (i.e declines of PSA, CA-125) have also been observed. Reductions in CTCs and tumor markers both suggest single-agent activity.
The abstract represents preliminary data on OGX-427 as a single agent. Updated data will be presented during an oral presentation at ASCO.
The oral presentations are scheduled to be held as shown below at the ASCO Annual Meeting in Orlando, Florida.
Presentation Information
Title: Mature results of a randomized phase II study of OGX-011 in
combination with docetaxel/prednisone versus
docetaxel/prednisone in patients with metastatic castration
resistant prostate cancer
Authors: K. N. Chi, S. J. Hotte, E. Yu, D. Tu, B. Eigl, I. Tannock, F.
Saad, S. North, J. Powers, E. Eisenhauer, National Cancer
Institute of Canada Clinical Trials Group
Date: 4:30 p.m. - 4:45 p.m. EDT, Saturday, May 30, 2009
Location: Level 3, Chapin Theatre, W320, Orange County Convention Center
Abstract: No. 5012
Title: OGX-427, a 2"methoxyethyl antisense oligonucleotide (ASO),
against HSP27: Results of a first-in-human trial
Authors: S. J. Hotte, E. Y. Yu, H. W. Hirte, C. S.Higano, M. Gleave, K.
N. Chi
Date: 2:00 p.m. - 2:15 p.m. EDT, Saturday, May 30, 2009
Location: Level 4, Valencia Room, W415A, Orange County Convention Center
Abstract: No. 3506
About OGX-011
OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance and is currently being evaluated in Phase 2 clinical trials in prostate, lung and breast cancer. At the 2008 Annual Meeting of the American Society of Clinical Oncology, OncoGenex reported Phase 2 data with OGX-011 in combination with second-line treatment of metastatic castrate resistant prostate cancer showing better than expected survival results, reductions in levels of clusterin, durable reductions in pain, and a decline in PSA, a protein that is often elevated in patients with prostate cancer.
Based on clinical results to date, OncoGenex intends to conduct Phase 3 registration trials with OGX-011 in metastatic castrate resistant prostate cancer, subject to the receipt of additional funding. The U.S. Food & Drug Administration (FDA) has agreed on the design of two Phase 3 registration trials, via the Special Protocol Assessment (SPA) process, of OGX-011 in combination with second-line chemotherapy. One trial design investigates overall survival as the primary endpoint; the other trial design investigates pain palliation as the primary endpoint. Based on the survival benefit observed after combining OGX-011 with first-line docetaxel chemotherapy, OncoGenex has initiated discussions with the FDA regarding evaluating the overall survival benefit in patients treated with first-line chemotherapy, rather than second-line chemotherapy.
OGX-011 has received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel.
About OGX-427
OGX-427 is designed to reduce production of Hsp27, a protein that is over-produced in response to many cancer treatments including hormone ablation therapy, chemotherapy and radiation therapy. Hsp27 production has been shown to inhibit cell death in tumor cells through a variety of mechanisms. OGX-427 is being evaluated in a Phase 1 clinical trial for the treatment of solid tumors including prostate, non-small cell lung, breast, ovarian, and bladder cancers. Like OGX-011, this product candidate has potential as a treatment in a broad number of cancers.
OncoGenex Pharmaceuticals, Inc.