Key Developments: OncoGenex Pharmaceuticals Inc (OGXI.OQ)

OGXI.OQ on NASDAQ Stock Exchange Capital Market

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Latest Key Developments (Source: Significant Developments)

OncoGenex Pharmaceuticals Inc announces update on phase 3 ENSPIRIT trial evaluating Custirsen in advanced non-small cell lung cancer
Thursday, 21 Aug 2014 04:00pm EDT 

OncoGenex Pharmaceuticals Inc:Says Phase 3 ENSPIRIT trial, evaluating custirsen in treatment of non-small cell lung cancer (NSCLC), is continuing as planned per recommendation of Independent Data Monitoring Committee (IDMC) based upon completion of first interim futility analysis.  Full Article

OncoGenex Pharmaceuticals Inc appoints CFO
Thursday, 7 Aug 2014 06:30am EDT 

OncoGenex Pharmaceuticals Inc:Appointment of John A. Bencich as Vice President and Chief Financial Officer.John Joining company effective Aug. 11.  Full Article

OncoGenex Pharmaceuticals announces pricing of $24 mln underwritten registered direct offering
Thursday, 26 Jun 2014 06:00pm EDT 

OncoGenex Pharmaceuticals Inc:Prices an underwritten registered direct offering, which is expected to raise gross proceeds of $24 million.Offering 5,559,866 Series A units at a purchase price per unit of $3.48.Each Series A unit will consist of one share of common stock and a Series A warrant to purchase up to one-half of one share of common stock at an initial exercise price of $4.00 per share.Offering is expected to close on or about July 2.  Full Article

Teva Pharmaceutical and OncoGenex announces top-line survival results of phase III SYNERGY Trial Evaluating Custirsen in Combination with First-line Docetaxel and Prednisone
Monday, 28 Apr 2014 07:00am EDT 

Teva Pharmaceutical Industries Ltd and OncoGenex Pharmaceuticals, Inc:Results from Phase III SYNERGY trial, a randomized, open-label, two-arm study comparing the combination of custirsen and standard first-line docetaxel/prednisone therapy to docetaxel/prednisone alone in men with metastatic castrate-resistant prostate cancer.Top-line survival results indicate addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet the primary endpoint of statistically significant improvement in overall survival (OS) in men with metastatic CRPC.Says compared to docetaxel/prednisone alone (median survival 23.4 months vs 22.2 months, respectively, hazard ratio 0.93 and one-sided p-value 0.207).  Full Article

OncoGenex Pharmaceuticals Inc announces fast track designation granted for custirsen in combination with Cabazitaxel/Prednisone
Wednesday, 23 Apr 2014 06:01am EDT 

OncoGenex Pharmaceuticals Inc:U.S. Food and Drug Administration (FDA) has granted Fast Track designation to investigation of custirsen when administered in combination with cabazitaxel/prednisone.Says for treatment of men with metastatic castrate-resistant prostate cancer (CRPC) following prior treatment with a docetaxel-containing regimen.Fast track is process designed to facilitate development, and expedite review, of drugs to treat serious conditions and fill an unmet medical need.Purpose is to get important new drugs to patient earlier.International, randomized, open-label Phase 3 AFFINITY trial is designed to evaluate if custirsen, when combined with second-line chemotherapy cabazitaxel and prednisone, has the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone.AFFINITY will enroll about 630 men and is expected to complete enrollment in second half of 2014.Custirsen has also received Fast Track designation from FDA for treatment of patients with metastatic non-small cell lung cancer as part of Phase 3 ENSPIRIT trial and for men with metastatic CRPC as part of the Phase 3 SYNERGY trial.Enrollment in ENSPIRIT trial is ongoing and top-line survival results from SYNERGY are expected by mid-2014.  Full Article

OncoGenex Pharmaceuticals Inc Announces Plans For Initiation Of Cedar Clinical Trial Evaluating OGX-427 In Combination With Chemotherapy In Advanced Squamous Cell Lung Cancer
Thursday, 23 May 2013 06:30am EDT 

OncoGenex Pharmaceuticals Inc announced plans for the initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer. This trial will be the seventh randomized Phase 2 clinical trial evaluating OGX-427 in the treatment of advanced cancers and will investigate whether adding OGX-427 to gemcitabine and carboplatin therapy can extend progression-free survival (PFS) outcomes. The trial is being conducted by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will involve 35 centres in the UK. Cedar will be the second randomized Phase 2 trial of OGX-427 in advanced lung cancer. OncoGenex also recently announced plans to initiate the Spruce trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer (NSCLC). Spruce is being conducted in partnership with the Sarah Cannon Research Institute (SCRI) and is expected to begin enrollment later this year.  Full Article

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
Wednesday, 1 May 2013 06:30am EDT 

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
Thursday, 11 Apr 2013 08:01am EDT 

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
Monday, 4 Feb 2013 05:28pm EST 

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
Wednesday, 19 Dec 2012 09:31am EST 

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

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