Key Developments: OncoGenex Pharmaceuticals Inc (OGXI.PH)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
OncoGenex Pharmaceuticals Inc Announces Plans For Initiation Of Rainier Clinical Trial Evaluating OGX-427 In Combination With ABRAXANE Plus Gemcitabine In Patients With Metastatic Pancreatic Cancer
OncoGenex Pharmaceuticals Inc announced plans for the initiation of the Rainier trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 in combination with ABRAXANE (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer. Rainier will randomize approximately 130 patients to receive either OGX-427 or placebo in combination with ABRAXANE and gemcitabine therapy. The primary endpoint of the trial will be overall survival, with additional analyses to evaluate progression-free survival (PFS), tumor response rates, safety, tolerability, and the effect of therapy on heat shock protein (Hsp27) levels. Full Article
OncoGenex Pharmaceuticals Inc Announces Plans For Initiation Of Spruce Clinical Trial Evaluating OGX-427 In Combination With Chemotherapy In Advanced Non-Squamous Non-Small Cell Lung Cancer
OncoGenex Pharmaceuticals Inc announced plans for the initiation of the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled Phase 2 study evaluating OGX-427 in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC). The trial will investigate whether adding OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival (PFS) outcomes. The Spruce clinical trial will randomize approximately 155 patients with non-squamous NSCLC to receive either OGX-427 plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy. Patients may also continue maintenance therapy with pemetrexed and/or OGX-427/placebo until disease progression or unacceptable toxicity. The primary objective will be PFS, with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability, and the effect of therapy on heat shock protein 27 (Hsp27) levels. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to treatment resistance and more aggressive cancer phenotypes. OGX-427 is a once-weekly intravenous (IV) drug that is designed to inhibit production of Hsp27 to disable cancer cells' defenses and overcome treatment resistance. Full Article
OncoGenex Pharmaceuticals Inc Announces Resignation OF CFO-Form 8-K
OncoGenex Pharmaceuticals Inc reported in its Form 8-K that on February 1, 2013, Ms. Burris resigned as the Company’s Principal Accounting Officer, Chief Financial Officer (CFO), Secretary and Treasurer. From February 1, 2013 to March 31, 2013, Ms. Burris will continue to serve as the Company’s Executive Vice President of Operations. Full Article
OncoGenex Pharmaceuticals Inc Announces Initiation Of Randomized Phase 2 PACIFIC Study Of OGX-427 In Combination With Zytiga In Men With Metastatic Castrate Resistant Prostate Cancer
OncoGenex Pharmaceuticals Inc announced the initiation of PACIFIC, an investigator-sponsored, randomized Phase 2 study evaluating OGX-427 in men with metastatic castrate-resistant prostate cancer (CRPC) who are experiencing a rising PSA while receiving Zytiga (abiraterone acetate). The aim of the study is to determine if adding OGX-427 to Zytiga treatment can reverse or delay treatment resistance. Approximately 80 men who are being treated with Zytiga and have evidence of a rising PSA, but no evidence of symptomatic or radiographic progression, will be randomized to either continue treatment with Zytiga and prednisone alone, or have OGX-427 added to the Zytiga and prednisone treatment. Patients will be stratified based on whether they have received prior chemotherapy and will continue on study until symptomatic, radiographic or other documented disease progression occurs. The primary objective will be to compare the two treatment groups for delaying further disease progression while on Zytiga by assessing the progression-free survival (PFS) rate at 60 days after adding OGX-427. Secondary objectives include comparing the treatment arms for PSA responses, objective responses, time to progression, circulating tumor cells (CTCs) and other biomarkers. Full Article
OncoGenex Pharmaceuticals Inc Announces Initiation Of A Phase 3 Trial For Custirsen In Advanced Non-Small Cell Lung Cancer
OncoGenex Pharmaceuticals Inc announced the initiation of ENSPIRIT, a Phase 3 trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have progressed after initial chemotherapy treatment has failed. The trial will investigate if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients. Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned. Full Article
OncoGenex Pharmaceuticals Inc Announces Initiation Of Phase III Affinity Trial For Patients With Advanced Prostate Cancer
OncoGenex Pharmaceuticals Inc announced that it has initiated patient enrollment in its second Phase III clinical trial evaluating custirsen in patients with advanced prostate cancer. The AFFINITY trial will evaluate if custirsen when combined with second-line chemotherapy has the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone. This Phase III trial is an international, randomized, open-label study that will enroll approximately 630 men with CRPC who received first-line docetaxel chemotherapy and have disease progression. Patients will be randomized to receive custirsen, cabazitaxel and prednisone or cabazitaxel and prednisone alone. The primary endpoint of the study is overall survival. Additional analyses will evaluate disease progression parameters and quality of life. Full Article
OncoGenex Pharmaceuticals Inc Announces Results From Phase 2 Study Of OGX-427
OncoGenex Pharmaceuticals Inc announced data from a Phase 2 study of investigational compound OGX-427 in chemotherapy-naive metastatic castration resistant prostate cancer (mCRPC). Preliminary results show higher number of patients taking OGX-427 plus prednisone without disease progression at 12 weeks and with declines in prostate-specific antigen (PSA), compared with those taking prednisone alone. 64 of 72 planned patients have been randomized to study and data on 42 patients are available at or beyond the 12 week assessment time point. The primary efficacy endpoint of this study is defined as the proportion of patients without disease progression at 12 weeks where disease progression is based on any of parameters PSA levels, measurable disease, bone lesions, global deterioration or requiring palliative radiation therapy. 50% of patients who received OGX-427 plus prednisone experienced a >50% decline in PSA, versus 20% of patients who received prednisone alone. Among the 21 patients with baseline measurable disease, 44% (4 of 9) in the OGX-427 plus prednisone arm had a measureable disease response compared to 0% (0 of 12) in the prednisone alone arm. There was 1 complete response in the OGX-427 plus prednisone arm. Circulating tumor cell declines from greater than or equal to 5 to <5 occurred in 55% of patients receiving OGX-427 plus prednisone compared to 41% of patients receiving prednisone alone. Full Article
OncoGenex Pharmaceuticals Inc Prices $50 Million Public Offering
OncoGenex Pharmaceuticals Inc announced that it has priced an underwritten public offering of 4,165,000 shares of its common stock at a purchase price of $12.00 per share. Net proceeds, after estimated underwriting discounts and commissions and estimated expenses, will be approximately $46.8 million. OncoGenex granted the underwriters a 30-day option to purchase up to an additional 624,750 shares of common stock to cover overallotments, if any. The offering is expected to close on or about March 21, 2012, subject to customary closing conditions. Leerink Swann LLC and Stifel Nicolaus Weisel are acting as joint book-running managers and Lazard Capital Markets LLC and William Blair & Company, L.L.C. are acting as co-managers. Full Article
OncoGenex Pharmaceuticals Inc's Phase 1 Study Of OGX-427 Shows Early Evidence Of Activity In Bladder Cancer
OncoGenex Pharmaceuticals Inc announced preliminary results from an investigator-sponsored Phase 1 study of patients with superficial bladder cancer with its investigational compound OGX-427, which is designed to inhibit the production of Hsp27. Hsp27 is a cell-survival protein expressed in many types of cancers including prostate, bladder, breast and non-small cell lung cancer. In patients with superficial bladder cancer, preliminary results of this Phase 1 study demonstrated a trend towards decreased levels of Hsp27 and increased tumor cell death rates after intravesical treatment with OGX-427. Additionally, of the 15 patients treated with OGX-427, 33% had complete responses with no pathologic evidence of disease observed in post-surgical tissue following 4 doses of OGX-427 administered intravesically over an 8 day period. The absence of residual disease post OGX-427 intravesical treatment prevented evaluation of Hsp27 levels and tumor cell death rates within tumor cells in these patients. Full Article
OncoGenex Pharmaceuticals Inc Announces Publication Of Phase I/II Custirsen (OGX-011/TV-1011) Data
OncoGenex Pharmaceuticals Inc announced data evaluating its investigational compound custirsen (OGX-011/TV-1011) in patients with advanced non-small cell lung cancer (NSCLC). 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 primary analysis. Key study findings are as follows 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; 12% 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. Full Article
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