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OncoGenex Pharmaceuticals, Inc.

Partner : ISIS Pharmaceutical, 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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December 1, 2015
OncoGenex Announces Phase 3 AFFINITY Trial with Custirsen Continues Following Interim Analyses
Final Results Expected in Second Half of 2016

BOTHELL Wash. and VANCOUVER, Dec. 1, 2015 /CNW/ -- Following an independent Data Monitoring Committee (DMC) meeting, OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that its Phase 3 AFFINITY trial is continuing based on the pre-planned interim futility analysis of the intent-to-treat (ITT) population. In the final safety review, no new safety issues were identified by the DMC. Both the DMC and OncoGenex remain blinded to all analyses and final results are expected in the second half of 2016, depending on timing of the event-driven final analysis.

AFFINITY is designed to evaluate whether the investigational treatment custirsen, when combined with cabazitaxel, improves survival in men with metastatic castrate-resistant prostate cancer (CRPC) whose disease has progressed following treatment with docetaxel. The final AFFINITY efficacy analysis is designed to show a survival benefit with 85 percent power based on a hypothesized hazard ratio of 0.75.

Separately, an analysis of a prospectively defined subpopulation of men in the AFFINITY trial who had multiple poor prognostic risk factors revealed that the combination of custirsen and cabazitaxel did not meet the rigorous criteria required to demonstrate an improvement in overall survival (hypothesized hazard ratio ≤0.69, one-sided p value ≤0.015). This subpopulation was identified and evaluated based on a retrospective analysis of a previous Phase 3 trial of men with similar clinical features who experienced a reduced risk of death when custirsen was added to chemotherapy. In addition, OncoGenex pursued the evaluation of this subpopulation, independent of the ITT, in order to obtain an expedited approval for these patients with more aggressive disease.

"The overall survival endpoint of the entire AFFINITY trial remains clinically meaningful and its target hazard ratio of 0.75 is attainable with sufficient power to demonstrate a benefit from custirsen for men who are battling advanced prostate cancer," said Scott Cormack, President and CEO of OncoGenex. "We designed the AFFINITY trial so that the final analysis of the ITT population could stand alone as a Phase 3 submission to regulatory agencies regardless of the outcome of the smaller subgroup."

As part of the Phase 3 development program for custirsen, OncoGenex continues with its ENSPIRIT clinical trial in patients with non-small cell lung cancer (NSCLC). The trial is evaluating the ability of custirsen, in combination with docetaxel treatment as second-line chemotherapy, to extend survival in patients with NSCLC. Based on current enrollment projections, ENSPIRIT results could be available in the second half of 2016.

The company also expects several additional clinical trial milestones in 2016 with its other lead product candidate apatorsen, which include:

Announcing results for the primary progression-free survival endpoint of the Phase 2 Spruce™ trial in advanced NSCLC
Announcing results of the Phase 2 Borealis-2™ trial in patients with metastatic bladder cancer
Completing enrollment in the Phase 2 Pacific™ trial in metastatic CRPC
Conference Call Details
OncoGenex will host a conference call at 4:30 p.m. Eastern Time today, Tuesday, December 1, 2015, to discuss today's news. A live event will be available on the Investor Relations section of the OncoGenex website at www.OncoGenex.com. Alternatively, visitors may access the live conference call by dialing (877) 606-1416 (U.S. & Canada) or (707) 287-9313 (International). A webcast replay will be available approximately two hours after the call and will be archived on www.OncoGenex.com for 90 days.
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Source: press release, 12/02/15. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=945022

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OncoGenex Announces EMA Support for Phase 3 AFFINITY Trial Protocol Amendment

Topline Results in Poor Prognosis Subpopulation Expected by End of Year

BOTHELL, Wash. and VANCOUVER, British Columbia, Oct. 8, 2015 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the European Medicines Agency (EMA) has completed its review of the proposed amendment to the company's Phase 3 AFFINITY protocol and statistical analysis plan. The amendment, which was agreed to by the U.S. Food and Drug Administration (FDA) earlier this year, includes the addition of a co-primary endpoint designed to prospectively evaluate the survival benefit of custirsen in men who are at increased risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer (mCRPC). The EMA supported plans for prospectively defining a poor prognostic subpopulation in the Phase 3 AFFINITY trial and suggested additional supportive analyses to show benefit for the poor prognostic subpopulation beyond the broader AFFINITY trial population. Following support from the FDA and EMA, the company is proceeding with its planned protocol amendment globally.

"We are pleased that we now have feedback from both U.S. and European regulatory authorities on our plan to prospectively evaluate this group of mCRPC patients who have increased risk factors for poor outcomes and who therefore are more likely to have shorter survival times," said Cindy Jacobs, PhD, MD, Chief Medical Officer and Executive Vice President of OncoGenex. "As we continue to gather insights from the SYNERGY trial, we are gaining a better understanding of the role clusterin plays in this vulnerable patient group and how custirsen may provide a survival benefit."

OncoGenex, in collaboration with study investigators, has defined a simple five-criteria characterization for poor prognostic patients with prostate cancer to be treated with custirsen based on the Phase 3 SYNERGY trial, which includes: 1) poor performance status, 2) elevated prostate specific antigen (PSA), 3) elevated lactate dehyrdogenase (LDH), 4) decreased hemoglobin and 5) the presence of liver metastasis. AFFINITY patients with poor prognosis will be identified as having two or more of these five well-recognized high-risk criteria. The proposed change for AFFINITY is also consistent with custirsen's mechanism of action, as custirsen was designed to address treatment resistance which may be more prevalent in this subpopulation.

In the revised statistical analysis plan for the AFFINITY trial, the hypothesized hazard ratio (HR) for the poor prognosis subpopulation is specified to be 0.69 with the critical HR ≤ 0.778. The hypothesized HR for intent-to-treat patients (ITT population) remains unchanged as 0.75 with the critical HR ≤ 0.820.

Timing for the final analysis of the poor prognosis subpopulation is projected to occur by the end of 2015, while the final analysis of the ITT population is projected to occur in the second half of 2016. An interim analysis of the ITT population will coincide with the final analysis of the poor prognosis subpopulation. This interim analysis will have both futility and early efficacy criteria defined for the ITT population. If the final analysis of the poor prognostic subpopulation shows a survival benefit for custirsen, OncoGenex may initiate a regulatory submission.

A retrospective analysis of data from the Phase 3 SYNERGY trial presented earlier this year showed a benefit with custirsen therapy when added to first-line docetaxel chemotherapy in men with mCRPC who had a poor prognosis. The analysis showed that over 40 percent of men in the SYNERGY trial had at least two of the five common risk factors for poor prognosis as stated above. In these men, the analysis found a 27 percent lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone.

In addition, exploratory SYNERGY data analyses recently presented at the 2015 European Cancer Congress (ECC 2015) demonstrated that custirsen treatment significantly lowered serum clusterin (sCLU) levels from baseline in men with mCRPC. In addition, these data showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes. Of those patients with lower sCLU levels, the data also showed a correlation to an overall survival benefit for custirsen-treated patients who were at increased risk for poor outcomes.

AFFINITY is being conducted at 95 global clinical trial sites. Earlier this year, the IDMC recommended the trial continue following the completion of an interim futility analysis. The trial is fully accrued and the protocol amendment does not affect the conduct of the study. Custirsen has Fast Track designation by the FDA for the poor prognosis and overall AFFINITY trial populations, as well as non-small cell lung cancer (NSCLC).
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Source: press release, 10/08/15. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=935729

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Scott Cormack, President & CEO, maintained guidance for data from the AFFINITY trial. He stated, "We expect to report topline results from the AFFINITY Phase 3 trial later this year or in early 2016."
Source: Q1 2015 earnings conference call, 5/14/15.

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As a result of the Phase 3 SYNERGY analysis, OncoGenex is seeking advice from the FDA and other regulatory authorities on plans to amend the Phase 3 AFFINITY trial statistical analysis plan and include an evaluation of survival benefit in men with poor prognosis. The meeting with the FDA will occur in June 2015. The analysis, if permitted by regulatory authorities, would evaluate patients who have at least two of five poor prognostic factors, which consist of: poor performance status, elevated prostate specific antigen, elevated lactate dehydrogenase, decreased hemoglobin or the presence of liver metastasis.
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Source: press release, 5/14/15. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=913298

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January 16, 2015

OncoGenex Announces Update on Phase 3 AFFINITY Trial Evaluating Custirsen in Men with Metastatic Castrate-Resistant Prostate Cancer

AFFINITY Trial to Continue as Planned Following Completion of Interim Futility Analysis

BOTHELL, Wash. and VANCOUVER, British Columbia, Jan. 16, 2015 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the AFFINITY trial is continuing as planned based upon completion of the interim futility analysis and the recommendation of the Independent Data Monitoring Committee (IDMC).

The Phase 3 AFFINITY trial is designed to evaluate a survival benefit for custirsen in combination with second-line cabazitaxel chemotherapy in 635 men with metastatic castrate-resistant prostate cancer (CRPC). AFFINITY is being conducted at 95 global clinical trial sites and final survival results are expected to be announced in late 2015 or early 2016.

"While the results remain blinded to OncoGenex, we are very pleased that the AFFINITY trial has passed this interim futility analysis and we remain confident in the potential value of custirsen in treating cancer, particularly in patients who have advancing disease despite previous treatments," said Scott Cormack, President and CEO of OncoGenex.

OncoGenex recently announced that it has executed an initial agreement with Teva Pharmaceuticals Industries, Ltd. to regain rights to custirsen, which is being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers.
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Source: press release, 1/16/15. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=891668

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September 16, 2014

OncoGenex Announces Completion of Patient Enrollment in the Phase 3 AFFINITY Trial of Custirsen in Combination with Cabazitaxel/Prednisone as Second-line Chemotherapy in Men with Metastatic Castrate-Resistant Prostate Cancer

BOTHELL, Wash. and VANCOUVER, B.C., Sept.16, 2014 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that patient enrollment has been completed in the Phase 3 AFFINITY trial.

The international, randomized, open-label Phase 3 AFFINITY trial is designed to evaluate the potential of custirsen to improve survival outcomes in approximately 630 men with metastatic castrate-resistant prostate cancer (CRPC). Patients have been randomized to receive second-line Jevtana® (cabazitaxel) and prednisone with or without custirsen.

"We are grateful to the AFFINITY investigators for their efforts, as well as the patients and their loved ones who are supporting this important trial. The pace of enrollment over the past six months has been a strong indication of the prostate cancer community's ongoing interest in custirsen, particularly in more heavily treated patients, like those in the AFFINITY trial," said Scott Cormack, President and CEO of OncoGenex. "OncoGenex' focus is on the science that may lead one day to preventing cancer from evading treatment, and we are pursuing this approach through the ongoing Phase 3 trials of custirsen and multiple Phase 2 trials of apatorsen in four different tumor types."

The timing of the survival primary endpoint data is event-driven and results are currently expected in late 2015 or early 2016.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the evaluation of custirsen in the AFFINITY trial. For more information on custirsen and the AFFINITY trial, please visit www.oncogenex.com.
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Source: press release, 9/16/14. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=870989

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Scott Cormack, President & CEO, gave guidance for the completion of enrollment in the phase-III AFFINITY trial. He stated, "Our custirsen Phase III AFFINITY trial is designed to evaluate the potential survival benefit of custirsen in combination with cabazitaxel, a second-line chemotherapy, in approximately 630 men with metastatic CRPC. Patient enrollment to the AFFINITY trial began in August 2012, and we currently expect to complete enrollment by the end of 2014."
Source: Q1 2014 earnings conference call, 4/30/14.

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April 23, 2014
OncoGenex Announces Fast Track Designation Granted for Custirsen in Combination with Cabazitaxel/Prednisone as Second-line Chemotherapy in Phase 3 AFFINITY Trial of Men with Metastatic Castrate-Resistant Prostate Cancer
Third Phase 3 Trial of Custirsen to Receive FDA Fast Track Designation
BOTHELL, Wash. and VANCOUVER, British Columbia, April 23, 2014 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of custirsen when administered in combination with cabazitaxel/prednisone for the treatment of men with metastatic castrate-resistant prostate cancer (CRPC) following prior treatment with a docetaxel-containing regimen.

Fast track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

The 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 approximately 630 men and is expected to complete enrollment in the second half of 2014.

Custirsen has also received Fast Track designation from the FDA for treatment of patients with metastatic non-small cell lung cancer as part of the Phase 3 ENSPIRIT trial and for men with metastatic CRPC as part of the Phase 3 SYNERGY trial. Enrollment in the ENSPIRIT trial is ongoing and top-line survival results from SYNERGY are expected by mid-2014.
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Source: press release, 4/23/14. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=841863

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Patient enrollment continues in the additional Phase 3 custirsen trials, AFFINITY and ENSPIRIT. The AFFINITY trial will evaluate the potential survival benefit of custirsen in combination with Jevtana® (cabazitaxel) as second-line chemotherapy in men with metastatic CRPC, and ENSPIRIT will evaluate the potential survival benefit of combining custirsen with docetaxel as second-line chemotherapy in patients with advanced or metastatic NSCLC.
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Source: press release, 5/02/13. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=761566

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August 7, 2012
OncoGenex Announces Initiation of the Phase 3 "AFFINITY" Trial for Patients with Advanced Prostate Cancer
A Phase 3 Trial Evaluating the Potential Clinical Benefit of Custirsen in Combination with Second-line Chemotherapy, Jevtana® (cabazitaxel), in Patients with Castrate-Resistant Prostate Cancer (CRPC)

BOTHELL, Wash., and VANCOUVER, British Columbia, Aug. 7, 2012 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that it has initiated patient enrollment in its second Phase 3 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.
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Source: press release, 8/07/12. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=698641

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March 8, 2012
Teva and OncoGenex Announce Updates to Custirsen Development Program in Advanced Prostate Cancer

Second Phase 3 Trial Evaluating Survival Benefit of Custirsen Planned to Initiate in 2012

JERUSALEM & BOTHELL, Wash. & VANCOUVER, British Columbia--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today an update on their development program for custirsen, a product candidate being evaluated in Phase 3 studies for castrate-resistant prostate cancer (CRPC).

In a revised agreement between the two companies, the clinical trial program will now include the initiation of a Phase 3 study to evaluate if custirsen has the potential to improve survival rates for prostate cancer patients when combined with the recently-approved, second-line chemotherapy drug Jevtana® (cabazitaxel).

The new trial, which aims to enroll approximately 630 men and is expected to begin later this year, will be conducted in lieu of the Prostate Cancer Saturn Study, a trial designed with a primary endpoint of measuring a durable pain palliation benefit for custirsen in second-line treatment of CRPC. The shift in focus to evaluate overall survival in second-line prostate cancer is a result of numerous, recently-approved agents that are redefining the standard of care in this patient setting.
Source: press release, 3/08/12. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=655689

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AFFINITY - A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)
Estimated Enrollment: 630
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01578655?term=OGX-011&phase=2&rank...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Custirsen sodium ProstateUrologyProstate cancerTRPM-2 inhibitorTestosterone-repressed prostate message-2 (TRPM-2)

Mechanism of action: Custirsen sodium is the eicosasodium salt of a mixed-backbone antisense oligodeoxynucleotide with chemosensitizing properties. Custirsen inhibits testosterone-repressed prostate message-2 (TRPM-2). Administration of custirsen abrogates the anti-apoptotic effect of TRPM-2, thereby sensitizing cells to chemotherapy and resulting in tumor cell death. TRPM-2 is an anti-apoptotic clusterin that is overexpressed by prostate cancer cells and is associated with chemoresistance.

Phase of Development: III

Event Type: Data: Phase III trial results

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

Results:

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OncoGenex Announces Results from the Phase 3 AFFINITY Trial of Custirsen in Men with Metastatic Castrate-Resistant Prostate Cancer
Conference Call on Tuesday, August 16, 2016 at 7:30 a.m. EDT
BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 16, 2016 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today results from the final analysis of AFFINITY, the Phase 3 trial of custirsen in men with metastatic castrate-resistant prostate cancer (CRPC) whose disease has 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/prednisone compared to cabazitaxel/prednisone alone.

The adverse events were consistent with those observed in previous trials of custirsen in metastatic CRPC. The final data will be submitted as a late-breaking abstract to the European Society for Medical Oncology (ESMO) Annual Congress 2016.

"We are obviously disappointed that custirsen was unable to demonstrate a survival benefit in prostate cancer. We would like to thank the patients who participated in the AFFINITY trial and their caregivers, as well as the investigators and their teams for their commitment to improving cancer care for patients who are in desperate need of new treatment options," said Scott Cormack, President and CEO of OncoGenex.

As a result of these data and previous custirsen findings, OncoGenex plans to initiate discussions with the U.S. Food and Drug Administration (FDA) to evaluate options related to an early analysis of the Phase 3 ENSPIRIT trial investigating custirsen in combination with docetaxel as second-line chemotherapy in patients with non-small cell lung cancer (NSCLC).

"Given that the ENSPIRIT trial has nearly completed enrollment and we believe there are likely a sufficient number of events to determine the effect of custirsen in NSCLC, we are eager to expedite the final data analysis, which would allow us to conserve resources and fully understand the value of the asset as we evaluate our alternatives to maximize shareholder value," said Cormack.

OncoGenex has engaged MTS Health Partners, LP as its advisor to assist with the exploration of strategic alternatives.

Conference Call Details
OncoGenex will host a conference call at 7:30 a.m. Eastern Time today, Tuesday, August 16, 2016, to discuss today's news. A live event will be available on the Investor Relations section of the OncoGenex website at www.OncoGenex.com. Alternatively, visitors may access the live conference call by dialing (877) 606-1416 (U.S. & Canada) or (707) 287-9313 (International). A webcast replay will be available approximately two hours after the call and will be archived on www.OncoGenex.com for 90 days.
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Source: press release, 8/16/16. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=984464

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