OncoGenex Announces Publication of Phase I/II Custirsen (OGX-011/TV-1011) Data in Journal of Thoracic Oncology

BOTHELL, Wash. and VANCOUVER, British Columbia, Jan. 4, 2012 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that data evaluating its investigational compound custirsen (OGX-011/TV-1011) in patients with advanced non-small cell lung cancer (NSCLC) were published in an early online version of the January 2012 issue of the Journal of Thoracic Oncology. These data provide additional clinical evidence for the potential of custirsen, a drug designed to block production of clusterin, a cell survival protein that is commonly overexpressed in several cancer types.

The single-arm trial, conducted at 15 sites in North America, evaluated treatment of custirsen in combination with a gemcitabine/platinum-based regimen in patients with previously untreated, advanced NSCLC. Eighty-one patients received at least one dose of custirsen and were included in the primary analysis. Key study findings are as follows:

• The median overall survival was 14.1 months and progression-free survival was 4.3 months.
• The one- and two-year survival rates were 54% and 30%, respectively; twelve percent of patients were still alive at a median follow-up of 41 months (range 38-59 months).
• 69% of patients had a clinical response defined as objective response or stable disease and 31% of patients had tumor responses defined as complete or partial responses.
• Custirsen treatment decreased serum clusterin levels in 95% of patients evaluated. In addition, patients who achieved a threshold minimum serum clusterin level of < / = 45 mcg/mL had a median survival of 27.1 months compared to 15.6 months for patients who did not.

The authors concluded that the survival data in this trial compared quite favorably with published data of patients receiving a gemcitabine/platinum-based regimen in a similar dose and schedule, with median survivals of approximately seven to 11 months. Additionally, they determined toxicity of the combination was not appreciably different from what has been reported for gemcitabine/platinum combinations.

"The identification and targeting of new therapeutic pathways, such as clusterin inhibition, are required in order to improve outcomes for cancer patients," said Dr. Janessa Laskin, a medical oncologist at the British Columbia Cancer Centre and the principal investigator on the study. "The data reported in this clinical trial warrant the need to further evaluate custirsen in a randomized, Phase III study in advanced lung cancer."

An abstract of the article can be found at http://www.ncbi.nlm.nih.gov/pubmed/22198426.

Lung cancer is the leading cause of cancer-related death. This year, in the United States alone, approximately 220,000 new cases will be diagnosed. Plans are underway for Teva and OncoGenex to initiate a Phase III clinical trial of custirsen in NSCLC expected to begin in 2012.

About Custirsen
Custirsen is an experimental drug that is designed to block the production of clusterin, a protein that, when over-produced, can be associated with tumor cell survival and hence treatment resistance, faster rates of progression, and shorter survival duration in many types of cancer.  

Custirsen has been administered to 294 patients with various types of cancer in Phase I and Phase II clinical trials. Most patients experienced one or more adverse events, some of which were attributable to either the disease itself or other treatments in the protocol. Most adverse events were mild and those commonly associated with custirsen consisted of flu-like symptoms. A total of 74 patients (25%) developed serious adverse events (SAEs). For 36 patients (12%) the events were considered by the Investigator to be possibly, probably or definitely related to study treatment (chemotherapy plus custirsen).The most common SAEs, occurring in > / = 2% of patients, associated with custirsen were febrile neutropenia, pyrexia, pleural effusion and dyspnea.

About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase III clinical development as a treatment in men with metastatic castrate-resistant prostate cancer. The companies plan to begin Phase III development of custirsen in first-line treatment of advanced, unresectable non-small cell lung cancer. OGX-427 is in Phase II clinical development; CSP-9222 and OGX-225 are currently in pre-clinical development. More information is available at www.OncoGenex.com.

OncoGenex' Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial initiation. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company's Quarterly Report on Form 10-Q for third quarter ended September 30, 2011. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

SOURCE OncoGenex Pharmaceuticals, Inc.