CEO Journal

OncoGenex ENSPIRIT Trial

POSTED AT 10/13/2016

To the Cancer Community,

As you may have seen in the press release distributed this morning, OncoGenex announced today results from the final analysis of ENSPIRIT, the Phase 3 trial of custirsen in people with advanced non-small cell lung cancer whose disease had progressed after initial chemotherapy treatment.  The trial did not meet the primary endpoint of demonstrating a statistically signifi..

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AFFINITY Results

POSTED AT 08/16/2016

Earlier this morning, we announced results from our AFFINITY trial evaluating custirsen in men with metastatic castrate-resistant prostate cancer whose disease had progressed after treatment with docetaxel. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with cabazitaxel and prednisone compar..

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Borealis-2 Trial Continues Following Successful Completion of Futility Analysis

POSTED AT 12/08/2015

This morning we shared an update that the company’s Phase 2 Borealis-2 trial in bladder cancer patients is continuing as planned following the successful completion of a pre-specified futility analysis. Today’s announcement is an important step in the ongoing development of our apatorsen program, as the trial is the third study evaluating apatorsen’s ability to improve outcomes for patients wi..

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Clinical update on the Phase 3 AFFINITY trial

POSTED AT 12/01/2015

OncoGenex announced today a clinical update on the Phase 3 AFFINITY trial. The trial is continuing based on the pre-planned interim futility analysis of the intent-to-treat (ITT) population, with final results expected in the second half of 2016. In the final safety review, no new safety issues were identified by the independent Data Monitoring Committee.

In addition, an analysis of a prospectively d..

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Third Quarter 2015 Update

POSTED AT 11/12/2015

Today on our third quarter 2015 earnings call we provided an update on our custirsen and apatorsen clinical programs and previewed anticipated milestones through the end of this year and into 2016. This is a pivotal time at OncoGenex, with the first AFFINITY data readout by the end of 2015 and a number of other significant readouts over the next 12 months with both product candidates.

Looking ahead, ..

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Borealis-2 Clinical Trial Evaluating Apatorsen in Relapsed or Refractory Metastatic Bladder Cancer Fully Enrolled

POSTED AT 09/29/2015

Today, we announced that the OncoGenex apatorsen program is progressing as planned in bladder cancer. Borealis-2, a randomized Phase 2 trial sponsored by Hoosier Oncology Group, is now fully enrolled with 200 patients at 27 sites across the United States. 

The trial is designed to evaluate the efficacy of apatorsen in combination with docetaxel in patients with advanced or metastatic bladder can..

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OncoGenex Presents Additional Phase 3 SYNERGY and Borealis-1™ Analyses at ECC 2015

POSTED AT 09/27/2015

Today, two key analyses from OncoGenex’ custirsen and apatorsen programs were presented at European Cancer Congress 2015, further supporting the mechanisms of action for these products and adding to the growing body of evidence demonstrating their potential clinical utility.

Custirsen

Results from an additional exploratory analyses of the Phase 3 SYNERGY tria..

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Second Quarter 2015 Update

POSTED AT 08/13/2015

Today on our quarterly earnings call we provided an update on our two product candidates, custirsen and apatorsen. These assets continue to demonstrate their potential value in the most vulnerable patients – those at increased risk for poor outcomes or more resistant disease. We have continued to apply these insights to our clinical program and have realized a number of important achievements over the las..

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DMC Recommends ENSPIRIT Continue Following Final Futility Analysis

POSTED AT 07/13/2015

I’m pleased to announce that the Independent Data Monitoring Committee recommended that OncoGenex’ Phase 3 ENSPIRIT trial evaluating custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) continue as planned following the second and final planned interim futility analysis.

Two interim analyses were originall..

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First Quarter 2015 Update

POSTED AT 2:00 PM, PT 05/14/2015

Over the last month we’ve announced several key milestones that are shaping the future of OncoGenex , and with multiple clinical data readouts in the coming months, this a very exciting time.  Today we reported earnings for the first quarter of 2015 and provided an update on our clinical development activities, upcoming American Society of Clinical Oncology (ASCO) presentations and other key mileston..

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TEVA TERMINATION AGREEMENT, ENSPIRIT AMENDMENT AND LINCOLN PARK CAPITAL FINANCING DEAL

POSTED AT 6:00 AM, PT 04/30/2015

Over the last week we’ve reached several exciting milestones to support the custirsen program, and today we provided an update on our development strategy, including:

  • the finalization of our termination agreement with Teva and the return of custirsen rights to OncoGenex;
  • updates to the development program, including a protocol amendment to the ENSPIRIT trial; and
  • ..

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Fourth Quarter and Year End 2014 Update

POSTED AT 2:00 PM, PT 03/26/2015

Today we reported fourth quarter and year end 2014 financial results. On the call today we provided an update on the development of our two clinical-stage assets – custirsen and apatorsen. Over the next 12 months, we expect a number of significant clinical events for these product candidates, including:

Borealis-1 Trial Results

POSTED AT 6:15 AM, PT 12/19/2014

Earlier today we announced results from our randomized, controlled Phase 2 Borealis-1 trial evaluating low and high dose (600mg and 1000mg) apatorsen in combination with gemcitabine/cisplatin chemotherapy compared to chemotherapy alone in the treatment of metastatic bladder cancer.

We are encouraged by the results as they show that patients who had..

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Completion of Patient Enrollment in the Apatorsen Phase 2 Rainier Trial

POSTED AT 6:00 AM, PT 12/16/2014

We are pleased to announce enrollment completion in the Phase 2 Rainier clinical trial. With an estimated 46,000 new pancreatic cancer cases in the U.S. each year and a low five-year survival rate of 6 percent,1 the patients and families of those suffering from this devastating disease have long been calling for additional, and improved, treatment strategies.

With Rainier..

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Third Quarter 2014 Update

POSTED AT 2:00 PM, PT 10/30/2014

Today we reported earnings for the third quarter 2014, and provided an update on our clinical development activities and milestones.

As discussed on the call, two important custirsen milestones were reached during the last quarter, including the successful completion of enrollment in the Phase 3 AFFINITY trial, evaluating custirsen in combination with cabazitaxel treatment as second-line chemotherapy..

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Completion of Patient Enrollment in the Phase 3 AFFINITY Trial

POSTED AT 09/16/2014

In recent years the prostate cancer treatment landscape has changed considerably with new therapies enabling patients with advanced disease to live longer. But even with these advances, treatment resistance continues to be a major challenge and it is critically important to identify new ways to extend survival for the approximately 300,000 men who die each year from prostate cancer.

By inhibiting clu..

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Phase 3 ENSPIRIT Trial Passes Important Milestone

POSTED AT 1:00 PM, PT 08/21/2014

Today, we announced that the Phase 3 ENSPIRIT trial, evaluating custirsen in the treatment of non-small cell lung cancer (NSCLC), is continuing as planned per the recommendation of the Independent Data Monitoring Committee (IDMC) based upon completion of the first interim futility analysis.

Despite advances that have been made in the use of molecular testing and treatment in NSCLC, chemotherapy remai..

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Second Quarter 2014 Update

POSTED AT 3:00 PM, PT 08/07/2014

Today we reported earnings for the second quarter 2014, and provided an update on our clinical development activities, milestones and management team.

We are pleased to announce that effective Monday, August 11th, John Bencich will be joining OncoGenex as Vice President and Chief Financial Officer. John is a seasoned financial executive in the life science and technology industries, having..

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Understanding the Role of Hsp27 in Lung Cancer

POSTED AT 8:00 AM, PT 07/01/2014

Today we announced initiation of the Cedar™ clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. The Cedar clinical trial is a part of OncoGenex’ ORCA™ program encompassing clinical trials of apatorsen. Apatorsen is curre..

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SYNERGY Top-Line Results

POSTED AT 9:00 AM, PT 04/28/2014

Earlier today we announced the top-line survival results in our Phase 3 SYNERGY trial. While the outcome of the SYNERGY trial is disappointing, we remain strong in our belief that targeting mechanisms of treatment resistance is a critical path forward in the fight against cancer. We continue to actively pursue this approach through two additional Phase 3 tria..

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2014: A Transformative Year

POSTED AT 1:45 PM, PT 03/11/2014

As we report earnings for the fourth quarter and year ended 2013, we acknowledge progress made to date while looking forward to much anticipated, critical milestones that will make 2014 a truly transformative year for our company.

Our lead product candidate, custirs..

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Target Number of Events Reached in Phase 3 SYNERGY Trial

POSTED AT 8:20 AM, PT 02/11/2014

Today we announced that the pre-specified number of events required for final analysis of the Phase 3 SYNERGY trial of custirsen in metastatic castrate-resistant prostate cancer (mCRPC) has been reached.

Overall survival results will remain blinded until all study data have been thoroughly reviewed and prepared for final analysis. Our teams are working diligently in order to announce survival results..

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What We Learned From the Prostate Cancer Saturn Study

POSTED AT 10:50 AM, PT 02/03/2014

Last week at ASCO GU in San Francisco, a poster was presented on the lessons learned about the Phase 3 Prostate Cancer SATURN Study, evaluating custirsen in combination with second-line chemotherapy compared to chemotherapy alone in patients with metastatic castrate-resistant prostate cancer (mCRPC). The study was designed to evaluate durable pain..

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The Future of Cancer Treatment

POSTED AT 9:20 AM, PT 01/21/2014

When a patient’s cancer therapy stops working, all hope may seem lost. At OncoGenex, our mission is to meet the challenge of treatment resistance through the development and commercialization of first-in-class, innovative therapies that have the potential to redefine treatment outcomes for patients with a variety of cancers.

Developing innovative treatments that address complex and unmet medica..

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Docetaxel + Androgen Deprivation Therapy Results Are "Practice-Changing"

POSTED AT 9:25 AM, PT 12/13/2013

On Dec. 5, 2013, the NCI announced the results of an NIH-funded study that showed improved survival outcomes in men with metastatic prostate cancer who received chemotherapy when starting hormone therapy. The study (E3805) enrolled 790 men who received either the hormone therapy known as androgen deprivation therapy (ADT) alone or ADT in comb..

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Improving Upon the Proven

POSTED AT 4:00 PM, PT 11/07/2013

Today we implemented a new format on our third quarter 2013 earnings call in an effort to respond to questions we have received throughout the quarter via investor meetings and web site inquiries. If you were able to listen to the call or the replay, I’d like to know what you thought of the revised format.

On the call we reiterated our excitement..

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