First-line trial currently shows median overall survival of 27.5 months
for OGX-011 in combination with docetaxel and prednisone and a 16.9
months overall survival for docetaxel and prednisone alone.
Achievement of survival benefit milestone results in release of
all remaining escrowed shares of OGXI.
BOTHELL, WA and VANCOUVER, Dec. 3 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced positive survival results from a randomized Phase 2 clinical trial of OGX-011 in combination with docetaxel and prednisone ('the OGX-011 arm') compared to docetaxel and prednisone alone ('the control arm') for first-line treatment of metastatic castrate resistant prostate cancer. The current 10.6 month median overall survival advantage observed in the OGX-011 arm represents an increase over the median survival observed in the control arm. Docetaxel was approved by the FDA based on a survival advantage of 2.4 months over mitoxantrone.
Based on the median overall survival advantage, the Board of Directors of OncoGenex Pharmaceuticals has approved the release of all of the remaining shares held in escrow pursuant to agreements related to Sonus Pharmaceuticals' merger with OncoGenex Technologies described in its Proxy Statement filed with the SEC on July 3, 2008. The escrow agreements provided for the release of 50% of the original number of shares held in escrow following the demonstration of at least a two-month improvement in survival in the OGX-011 arm as compared to the control arm. All milestone shares have now been released from escrow; as of December 3, 2008 there are 5,513,643 shares outstanding.
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. Previous results regarding the primary endpoint analysis (PSA response) were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 2, 2007.
The study randomized 82 patients with metastatic or locally recurring prostate cancer refractory to hormone therapy. The median survival was 27.5 months for the patients in the OGX-011 arm and 16.9 months for those in the control arm. Results currently indicate that patients in the OGX-011 arm have a death rate approximately 40% lower than patients in the control arm. The current results are based on study data with a median follow-up of approximately 30 months for both arms. Additional survival updates are needed before a mature median survival for the OGX-011 arm can be reported.
