oncogenex pharmaceutical inc (OGXI) Key Developments
OncoGenex Pharmaceuticals, Inc. Announces Encouraging Results from Phase II Bladder Cancer Analysis
Jun 16 15
OncoGenex Pharmaceuticals, Inc. has announced results from an exploratory analysis of the Phase II Borealis-1 trial, which showed that metastatic bladder cancer patients with poor prognostic features benefited from apatorsen 600mg added to first-line chemotherapy compared to chemotherapy alone. Patients in the trial with a Karnofsky Performance Status (KPS) of 80% or less, a common indicator of poor prognosis, experienced a 50% reduction in risk of death with the addition of apatorsen therapy (OS HR = 0.50). The trial enrolled approximately 180 patients with documented metastatic or locally inoperable transitional cell carcinoma (TCC) of the urinary tract who had not previously received chemotherapy for metastatic disease and were not candidates for potentially curative surgery or radiotherapy. Patients were randomized to receive standard chemotherapy (gemcitabine/cisplatin) in combination with apatorsen at two dose levels (600mg and 1000mg) or gemcitabine/cisplatin plus placebo. The primary endpoint of the trial was overall survival. Secondary endpoints measured disease response as well as safety of each of the two doses of apatorsen. Exploratory analysis of study results showed that survival outcome was impacted by the following prognostic risk factors: KPS, liver involvement, low hemoglobin and high alkaline phosphatase. Patients who had these poor prognostic features benefited most from 600mg apatorsen therapy. Median overall survival in the poor prognostic group was 11.9 months with 600mg apatorsen + gemcitabine/cisplatin compared to 9 months with gemcitabine/cisplatin alone (OS HR = 0.77). Importantly, 33% of patients in the trial had a KPS less than or equal to 80%, which was found to be the single most important risk factor for poor prognosis. These lower KPS, high-risk patients experienced a 50% reduction in risk of death (OS HR = 0.50) when 600mg apatorsen was added to chemotherapy. Overall treatment was well tolerated. Most common Grade greater than or equal to 3 adverse events (AEs) were neutropenia, anemia, thrombocytopenia and hypertension. Frequency of greater than or equal to 3 Grade toxicities were: 89% (GC), 93% (GC+A 600) and 95% (GC+A 1000). GC+A 1000 had a higher treatment discontinuation rate due to AEs.
OncoGenex Pharmaceuticals, Inc. - Special Call
Jun 1 15
To discuss the results from the Borealis-1 trial as well as data presented at ASCO from the SYNERGY trial of custirsen in patients with metastatic castrate-resistant prostate cancer
OncoGenex Announces Data from the Phase 3 SYNERGY Trial Showing a Survival Benefit with Custirsen in Patients with Poor Prognosis
May 30 15
OncoGenex Pharmaceuticals, Inc. announced that results from a retrospective analysis of the Phase 3 SYNERGY trial showed a benefit with custirsen therapy in men with metastatic castrate-resistant prostate cancer (CRPC) who had a poor prognosis. The analysis, exploring the effect of clusterin inhibition in men at risk for poor outcomes, showed that over 40% of men in the trial had at least two of five common risk factors for poor prognosis. In these men, the analysis found a 27% lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone. These results were presented at the 51st Annual Meeting of the American Society of Clinical Oncology in Chicago. Custirsen is designed to block the production of the protein clusterin, which is overexpressed in a number of cancers and has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration in patients. OncoGenex, in collaboration with study investigators, have defined a simple 5-criteria characterization for poor prognosis in prostate cancer based on the SYNERGY trial, which include: poor performance status, elevated prostate specific antigen (PSA), elevated lactate dehyrdogenase (LDH), decreased hemoglobin, and the presence of liver metastasis. The findings from the SYNERGY study show a preferential effect in patients who are more vulnerable to poor outcomes and may reveal the patient population most likely to benefit from clusterin inhibition in other studies. The Company will be meeting with the U.S. Food and Drug Administration (FDA) in June to discuss a proposed amendment to the Phase 3 AFFINITY trial protocol and statistical analysis plan that would include a co-primary endpoint evaulating survival in men who are at increased risk for poor outcomes. In the AFFINITY trial, custirsen is being evaluated with second-line chemotherapy in men with metastatic CRPC. Results from this trial are expected later this year or in early 2016. Custirsen is also being evaluated in the international Phase 3 ENSPIRIT trial of patients with non-small cell lung cancer (NSCLC) who have progressed following initial treatments. OncoGenex recently filed an amendment with the FDA and has initiated, or will be initiating, filings with regulatory agencies in other countries as it becomes the sponsor in those specific regions to amend the statistical design and analysis plan to more rigorously and expediently evaluate the potential survival benefit associated with custirsen in this aggressive disease. The second and final interim futility analysis will be conducted in mid-2015 and if passed, final survival results could be available as soon as the second half of 2016.
OncoGenex Pharmaceuticals, Inc. Files Certificate of Amendment to its Amended and Restated Certificate of Incorporation
May 22 15
Following approval by its stockholders at the 2015 annual meeting on May 21, 2015, OncoGenex Pharmaceuticals, Inc. filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation. The Certificate Amendment, which is effective as of May 21, 2015, increased the number of the company's authorized shares of common stock from 50,000,000 shares to 75,000,000 shares.
OncoGenex Pharmaceuticals, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2015
May 14 15
OncoGenex Pharmaceuticals, Inc. reported earnings results for the first quarter ended March 31, 2015. Revenue was $1.4 million compared with $11.7 million for the first quarter of 2014. Revenue earned in the first quarter of 2015 consists of reimbursable clinical trial, manufacturing and preclinical costs incurred by OncoGenex under the collaboration agreement with Teva. Net loss was $4.5 million, or $0.20 per diluted common share, compared with $8.6 million, or $0.59 per diluted common share for the first quarter ended March 31, 2014.