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OncoGenex Pharmaceuticals, Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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As of December 31, 2015, the Company's cash, cash equivalents and short-term investments were $55.2 million. Based on current expectations, the Company believes that resources will be sufficient to fund currently planned operations into the third quarter of 2017. Depending on timing of enrollment or event-driven final analyses, the expected timing of key milestones and activities are as follows:

Custirsen
Announcing AFFINITY trial results, the phase 3 trial evaluating a survival benefit for custirsen in combination with cabazitaxel as second-line chemotherapy in approximately 630 patients with castrate-resistant prostate cancer. The final analysis for the intent-to-treat population is expected in the third quarter of 2016.

Announcing ENSPIRIT trial results, the phase 3 trial evaluating a survival benefit for custirsen in combination with docetaxel as second-line chemotherapy in approximately 700 patients with non-small cell lung cancer. The final survival analysis is expected in the first half of 2017.

Apatorsen
Announcing Borealis-2™ trial results, an investigator-sponsored, randomized phase 2 trial evaluating apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in patients with advanced or metastatic bladder cancer. Final results are expected in the second half of 2016.

Announcing Spruce™ trial results for the overall survival endpoint, the investigator-sponsored, randomized, placebo-controlled phase 2 trial evaluating apatorsen treatment with carboplatin and pemetrexed chemotherapy in patients with previously untreated advanced non-squamous NSCLC. Results are expected in the second half of 2016.

Preparing an investigational new drug application for FDA submission of apatorsen for intravesical administration in combination with Bacillus Calmette-Guerin (BCG)
treatment in patients with non-muscle invasive bladder cancer.
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Source: press release, 2/04/16. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=953452

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OncoGenex Announces Apatorsen Phase 2 Borealis-2 Trial Continues Following Successful Completion of Futility Analysis

Data Safety Monitoring Board Recommends Continuation of Trial as Planned in Bladder Cancer Patients

BOTHELL, Wash. and VANCOUVER, British Columbia, Dec. 9, 2015 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the independent Data Safety Monitoring Board (DSMB) at Dana-Farber/Harvard Cancer Center has recommended that the Phase 2 Borealis-2™ trial continue as planned after completing the pre-specified futility analysis.

Borealis-2 is evaluating apatorsen in combination with docetaxel treatment in patients with metastatic bladder cancer. It is the third clinical trial assessing the ability of apatorsen to improve outcomes for patients in this tumor type. Previously, encouraging results were observed in the Borealis-1™ trial evaluating apatorsen in combination with standard of care chemotherapy in metastatic bladder cancer, as well as a trial evaluating apatorsen as monotherapy in patients with non-muscle invasive (superficial) disease.

Investigators have concluded in the bladder cancer trials conducted to date that 600mg apatorsen administered intravenously and all apatorsen doses administered intravesically have been well tolerated. Clinical trials of apatorsen across four tumor types involving over 700 patients have been conducted or are currently ongoing with patient safety monitored throughout the course of these trials.

"We are pleased with the DSMB's recommendation to continue the Borealis-2 trial and we look forward to final results expected in 2016," said Scott Cormack, President and Chief Executive Officer of OncoGenex. "Additionally, early next year we will receive regulatory feedback on our apatorsen clinical trial design and development strategy for patients with non-muscle invasive bladder cancer."

Borealis-2 is an investigator-sponsored, randomized Phase 2 trial evaluating a survival benefit with apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in approximately 200 patients with metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. The trial is being coordinated by the Hoosier Cancer Research Network at 27 sites across the United States.

Upcoming Milestones
In addition to Borealis-2, OncoGenex expects to announce progression-free survival results for the Phase 2 Spruce™ trial in the first quarter of 2016 with continued overall survival follow up.

The company's other asset, custirsen, is currently being evaluated in two ongoing Phase 3 clinical trials. The Phase 3 ENSPIRIT trial is evaluating the ability of custirsen, in combination with docetaxel treatment as second-line chemotherapy, to extend survival in patients with metastatic NSCLC. ENSPIRIT passed a rigorous final futility survival analysis in July and the trial is continuing as planned. Based on current enrollment projections, ENSPIRIT results could be available in the second half of 2016.

The Phase 3 AFFINITY trial is evaluating the ability of custirsen, in combination with cabazitaxel as second-line chemotherapy, to extend survival in men with metastatic CRPC whose disease has progressed following treatment with docetaxel. Final results from the AFFINITY trial for the intent-to-treat population are expected in the second half of 2016.
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Source: press release, 12/09/15. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=946232

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OncoGenex Announces Completion of Patient Enrollment in Borealis-2™ Clinical Trial Evaluating Apatorsen in Relapsed or Refractory Metastatic Bladder Cancer

Patients More Likely to Have Treatment Resistance and Poor Prognosis

BOTHELL, Wash. and VANCOUVER, British Columbia, Sept. 30, 2015 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that Borealis-2™, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is sponsored by Hoosier Oncology Group and is being conducted at 27 sites across the United States.

Patients enrolled in Borealis-2 were randomized to receive either apatorsen plus docetaxel or doecetaxel alone. Patients could continue weekly apatorsen infusions as maintenance treatment until disease progression or unacceptable toxicity if they completed all 10 planned cycles of docetaxel or discontinued from docetaxel due to toxicity. Evaluation of overall survival is the primary study objective.

"Patients with advanced metastatic bladder cancer, who have failed initial therapies, typically have a poor prognosis with very limited therapeutic options. This is clearly an unmet therapeutic need," said overall principal investigator Toni Choueiri, MD, Clinical Director, Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute. "Recently reported apatorsen data have shown that Hsp27 inhibition improves survival in patients with poor prognosis. We hope to confirm those findings with the Borealis-2 trial results."

Data from the Borealis-1TM trial previously reported at the American Society of Clinical Oncology Annual Meeting earlier this year showed that metastatic bladder cancer patients with poor prognostic features (low performance status, liver involvement, low hemoglobin and high alkaline phosphatase) showed a potential survival benefit with apatorsen 600mg added to first-line chemotherapy (HR = 0.72) compared to chemotherapy alone. Patients in the trial with a Karnofsky Performance Status of 80 percent or less, a common indicator of poor prognosis, experienced a 50 percent reduction in risk of death with the addition of apatorsen therapy (HR = 0.50). Based on findings from the Borealis 1 trial, OncoGenex and the Hoosier Oncology Group plan to evaluate overall survival in patients with poor prognostic factors in the Borealis-2 trial.

"Patients in Borealis-2 are at an increased risk for poor outcomes given their disease has progressed after first-line treatment. Based on recent findings, we are seeing evidence that apatorsen may work in a variety of treatment settings within the bladder cancer paradigm," said Scott Cormack, President and CEO of OncoGenex. "We are thankful to the trial investigators and patients for their participation and we are eager for the results of this trial to inform our broader apatorsen program. We are working closely with investigators to determine next steps given the need and urgency for new bladder cancer treatments."
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Source: press release, 9/30/15. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=934391

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The Borealis-2™ Trial is an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. Borealis-2 was initiated in April of 2013 and aims to enroll approximately 200 patients.
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Source: press release, 5/02/13. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=761566

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April 30, 2013
OncoGenex Announces that the Borealis-2™ Clinical Trial of OGX-427 in Previously Treated Metastatic Bladder Cancer is now Open for Enrollment
The OGX-427 ORCA™ Program Continues to Expand with Patient Enrollment Now Open for Second Phase 2 Trial of OGX-427 in Advanced Bladder Cancer

BOTHELL, Wash. and VANCOUVER, British Columbia, April 30, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Borealis-2™ clinical trial, an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy treatment.

Borealis-2 will randomize approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone. Patients may also continue weekly OGX-427 infusions as maintenance treatment until disease progression or unacceptable toxicity if they complete all 10 planned cycles of docetaxel or are discontinued from docetaxel due to docetaxel toxicity. The primary endpoint of the trial is overall survival, with secondary objectives to evaluate safety, tolerability, tumor response rates and the effect of therapy on heat shock protein (Hsp27) levels and circulating tumor cells.

"Resistance to initial chemotherapy is a frequent occurrence in patients with advanced bladder cancer, and is often frustrating for physicians and devastating for patients who have limited treatment options available," stated Noah M. Hahn MD, Associate Professor of Medicine at Indiana University Simon Cancer Center and one of the primary investigators on the trial. "We hope that this trial will shed new light on the role of Hsp27 in bladder cancer and the ability of OGX-427 to work synergistically with second- or third-line chemotherapy to overcome resistance and prolong survival."

Borealis-2 is the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer. Borealis-1™ is a company-sponsored, randomized, placebo-controlled Phase 2 trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer. If either Borealis trial shows a survival advantage, OncoGenex plans to initiate conversations with the Food and Drug Administration about the possibility of a Phase 3 trial of OGX-427 in bladder cancer as part of the ORCA™ program.

Borealis-2 is being conducted at approximately 30 sites in the U.S. and is sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from the Indiana University Simon Cancer Center, Dr. Toni Choueiri from the Dana-Farber Cancer Institute and Dr. Jonathan Rosenberg from Memorial Sloan-Kettering Cancer Center will serve as the primary investigators on the trial. Please visit http://clinicaltrials.gov/show/NCT01780545 for more information.
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Source: press release, 4/30/13. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=760386

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February 12, 2013
OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial Evaluating OGX-427 in Combination with Second-Line Therapy for Bladder Cancer
Company Reaffirms Commitment to Addressing Treatment Resistance in Genitourinary (GU) Cancers with Fourth Phase 2 GU trial in OGX-427 ORCA Program

BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 12, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Borealis-2 clinical trial, an investigator-sponsored, randomized, controlled Phase 2 study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy treatment. The trial, which is the fourth Phase 2 study of OGX-427 in a genitourinary (GU) cancer, will investigate if combining OGX-427 with docetaxel, a standard option in salvage treatment for metastatic bladder cancer, improves survival compared to docetaxel alone.
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Source: press release, 2/12/13. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=739630

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Borealis-2 - The Borealis-2 Clinical Trial: A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Combination With OGX-427 in Patients With Relapsed or Refractory Metastatic Urothelial Carcinoma After Receiving a Platinum-containing Regimen: Hoosier Oncology Group GU12-160
Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/show/NCT01780545

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Apatorsen (OGX-427) Bladder CancerUrologyBladder cancerHsp27 inhibitorHeat shock protein 27 (Hsp27)

Mechanism of action: Apatorsen (OGX-427) (Hsp27 antisense oligonucleotide) is a second-generation antisense oligonucleotide targeting heat shock protein 27 (Hsp27) with potential antitumor and chemosensitizing activities. Hsp27 antisense oligonucleotide OGX-427 suppresses tumor cell expression of Hsp27, which may induce tumor cell apoptosis and enhance tumor cell sensitivity to cytotoxic agents. Hsp27, a chaperone belonging to the small heat shock protein (sHsp) group of proteins, is a cytoprotective protein that supports cell survival under conditions of stress; it has been found to be over-expressed in a variety of human cancers.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2016-07-01 - 2016-09-30

Results:

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October 25, 2016
OncoGenex Announces Positive Survival Results from Apatorsen Phase 2 Borealis-2™ Trial in Metastatic Bladder Cancer
Randomized Trial of 200 Patients Meets Primary Endpoint of Overall Survival

BOTHELL, Wash. and VANCOUVER, British Columbia, Oct. 25, 2016 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today positive survival results from the final analysis of the Phase 2 Borealis-2™ trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone (HR=.80; 95% CI: 0.65-0.98; p=0.078). The primary analysis was a superiority test of overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test. The trial was conducted by the Hoosier Cancer Research Network at 28 sites across the United States.

Safety results in patients treated with apatorsen and docetaxel were similar to those observed in patients treated with docetaxel alone.

"People living with advanced bladder cancer who have failed initial therapies have few treatment options available to them. While research across different treatment modalities is underway, there continues to be a high unmet therapeutic need," said one of the principal investigators, Jonathan Rosenberg, MD of Memorial Sloan Kettering Cancer Center. "The totality of the data evaluating apatorsen across first- and second-line chemotherapy treatment for bladder cancer suggests that it may provide clinical benefits in this highly aggressive disease."

Apatorsen is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells' defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes.

"We are encouraged by these data that further support Hsp27 as a therapeutic target and add an additional level of evidence to previously completed trials of apatorsen in patients with bladder cancer," said Scott Cormack, President and CEO of OncoGenex. "We look forward to completing the full data analysis from Borealis-2 and considering these data in our continuing work with MTS Health Partners in the exploration of strategic alternatives as announced in mid-August."
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Source: press release, 10/25/16. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=995427

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