WASHINGTON (dpa-AFX) - Cancer is the second most common cause of death in the U.S., exceeded only by heart disease, accounting for nearly 1 of every 4 deaths, according to the American Cancer Society. About 571,950 Americans are estimated to have died from cancer in 2011, which corresponds to more than 1,500 deaths per day. A report by Global Industry Analysts Inc., forecasts that the world market for cancer therapies will reach $225 billion by the year 2017. Vying to penetrate this lucrative market is OncoGenex Pharmaceuticals Inc. (OGXI), a biopharmaceutical company based in Bothell, Washington. For readers who are new to OncoGenex, here's a brief overview of its product pipeline and upcoming events to keep an eye on... The company's investigational drugs in clinical development are Custirsen, a phase III drug candidate for prostate cancer, and OGX-427 under phase II testing for advanced bladder cancer and prostate cancer. Also in the pipeline are pre-clinical drug candidates - CSP-9222 and OGX-225. OncoGenex has established partnerships with Teva Pharmaceutical Industries Ltd. (TEVA) and Isis Pharmaceuticals Inc. (ISIS). Custirsen is the lead product candidate of OncoGenex. Two phase III trials with Custirsen, dubbed SATURN and SYNERGY, are ongoing. The SATURN trial, which was initiated in June 2010, is designed to enroll about 300 men with metastatic castration-resistant prostate cancer, or CRPC, who have previously responded to first-line docetaxel (Taxotere) therapy, but subsequently have disease progression that involves prostate cancer-related pain despite opioid usage. The primary endpoint of the SATURN trial will be to determine whether durable pain palliation for 12 weeks or more is observed in a greater proportion of patients treated with docetaxel/prednisone plus Custirsen compared to docetaxel/prednisone plus placebo. The study is currently recruiting participants and trial results are expected in the fourth quarter of 2013. The SYNERGY trial was initiated late September 2010 with designated recruitment of 800 men with metastatic CRPC who have disease progression and require first-line docetaxel/prednisone chemotherapy. Patients will be randomized to receive treatment with either docetaxel/prednisone plus Custirsen or with docetaxel/prednisone alone. The primary endpoint of the SYNERGY trial is to determine whether overall survival is longer in the Custirsen treatment arm. The study is currently recruiting participants and trial results are expected in the fourth quarter of 2013. OncoGenex and Teva plan to conduct yet another phase III study to evaluate a survival benefit for Custirsen in combination with first-line chemotherapy in patients with non-small cell lung cancer, or NSCLC. This trial is yet to commence. The second clinical drug candidate of OncoGenex is OGX-427. Currently, three trials evaluating OGX-427 are underway - a phase I, investigator-initiated trial in superficial or muscle-invasive bladder cancer; a randomized, phase II, investigator-initiated trial in chemotherapy-naive, castrate-resistant prostate cancer; and an international, phase II, OncoGenex-sponsored trial in metastatic bladder cancer. The phase I clinical trial of OGX-427 in bladder cancer was initiated in August 2009. The study, which will enroll up to 36 patients with bladder cancer, is designed to determine the safety and potential benefit of OGX-427 administered directly into the bladder using a catheter, which is called intravesical instillation. Preliminary data from the phase I study is expected to be presented on February 3rd at the American Society of Clinical Oncology 2012 Genitourinary Cancers Symposium. The trial is expected to be completed in April 2017. The phase II trial of OGX-427 in castration resistant prostate cancer patients was initiated in September 2010 and is designated to enroll up to 72 patients. The primary efficacy endpoint will be the proportion of patients without disease progression at the 12-week evaluation after treatment with corticosteroid drug Prednisone given with or without OGX-427. The company is scheduled to present preliminary data from this study on February 2nd at the American Society of Clinical Oncology 2012 Genitourinary Cancers Symposium. The study is expected to be completed in November 2012. The international, phase II clinical trial evaluating OGX-427 in advanced bladder cancer was initiated last October. The study is a double blind, placebo-controlled, 3-arm, randomized trial that will enroll about 180 patients with advanced bladder cancer who have not previously received chemotherapy for metastatic disease and are not candidates for potentially curative surgery or radiotherapy. Patients will be randomized to receive gemcitabine, cisplatin, and OGX-427 at two dose-levels (600 mg and 1000 mg) vs. gemcitabine, cisplatin, and placebo. The study is expected to be completed in June 2014. A quick look at OncoGenex balance sheet... The company has no marketed drugs and has incurred losses in each year since its inception. OncoGenex recognizes revenue through its strategic collaboration with Teva. In the third quarter ended September 30, 2011, the company earned $4.5 million or $0.45 per share, reversing a year-ago quarterly loss of $6.9 million or $1.07 per share. Revenue for the third quarter of 2011 decreased to $1.2 million from $4.9 million in the comparable quarter a year before. The company has zero debt and year-end (2011) cash balance had been predicted in the range of $58 million to $62 million. OGXI has gained more than 40% in the last 3 months. The stock has thus far hit a 52-week low of $8.63 and a 52-week high of $18.99. At last check, OGXI was trading around $13.41.
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