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OncoGenex Pharmaceuticals, Inc.

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THERE IS AN ENTRY FOR THIS EVENT IN THE RESULTS SECTION (below) - PLEASE SCROLL DOWN TO VIEW.

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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 and Sarah Cannon Announce Completion of Patient Enrollment in the Spruce™ Clinical Trial Evaluating Apatorsen in Combination with Carboplatin and Pemetrexed in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 24, 2015 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (OGXI) and Sarah Cannon announced today that patient enrollment has been completed in the Spruce™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung cancer (NSCLC). Spruce is sponsored and led by Sarah Cannon Research Institute (SCRI), the research arm of Sarah Cannon, Hospital Corporation of America's (HCA) global cancer enterprise, and is being conducted at 16 sites across the United States.

In the Spruce trial, approximately 155 patients were randomized to receive either apatorsen or placebo in combination with carboplatin and pemetrexed therapy. The primary objective of the trial is progression-free survival (PFS), with additional analyses to evaluate overall survival, tumor response rates, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.

"Despite advances in targeted therapies to treat lung cancer, the majority of patients lack specific biomarkers and chemotherapy remains a mainstay of treatment for these patients," stated David Spigel MD, Director of the Lung Cancer Research Program at Sarah Cannon Research Institute and trial study chair. "The Spruce trial will enable us to better understand the role of apatorsen in treating NSCLC and its potential to delay or prevent treatment resistance and improve survival outcomes for these patients who urgently need more effective treatment options."

Spruce is one of two randomized Phase 2 trials of apatorsen in NSCLC. The Cedar™ clinical trial, an investigator-sponsored, randomized, open-label, Phase 2 trial evaluating apatorsen in patients with previously untreated, advanced, squamous cell lung cancer is currently enrolling. Cedar is being conducted and funded primarily by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network at approximately 20 centers in the United Kingdom. For more information on OncoGenex or the Spruce trial, please visit www.oncogenex.com or http://clinicaltrials.gov/show/NCT01829113.
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Source: press release, 2/24/15. http://www.oncogenex.com/about-us/news

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August 1, 2013
OncoGenex Announces that the Spruce™ Clinical Trial Evaluating OGX-427 in Combination with Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer is Now Open for Enrollment
The ORCA™ Program Continues to Expand with Patient Enrollment Now Open for First Phase 2 Trial of OGX-427 in Non-Small Cell Lung Cancer

BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 1, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Spruce™ clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled Phase 2 trial evaluating OGX-427, a heat shock protein 27 (Hsp27) inhibitor, in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).

Spruce 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 of the trial is progression-free survival (PFS), with additional analyses to evaluate tumor response rates, overall survival, safety, tolerability, and the effect of therapy on Hsp27 levels.

"There continues to be an urgent need for a majority of patients with lung cancer who lack specific biomarkers and will receive non-targeted treatments like chemotherapy," stated David Spigel MD, Director of the Lung Cancer Research Program, Sarah Cannon Research Institute (SCRI), and the primary investigator on the trial. "We hope that opening this trial will lead to us better understanding the role of Hsp27 in non-small cell lung cancer, and the ability of OGX-427 to work with chemotherapies in order to delay or prevent treatment resistance and improve survival outcomes for these patients."

Spruce is sponsored by SCRI and will be conducted at approximately 20 sites within the SCRI network in the United States. Visit http://clinicaltrials.gov/show/NCT01829113 for more information. Spruce is one of six Phase 2 clinical trials in the ORCA™ Program evaluating OGX-427 in the treatment of advanced cancers, and the first of two randomized Phase 2 trials of OGX-427 in NSCLC to open. OncoGenex also recently announced plans to initiate the Cedar™ clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in patients with previously untreated, advanced, squamous cell lung cancer. Cedar is being conducted in partnership with the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and is expected to begin enrollment later this year.
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Source: press release, 8/01/13. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=781955

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The Spruce™ Trial is 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). Plans for Spruce were announced in April of 2013 and patient enrollment of approximately 155 patients is expected to begin in mid-2013.
More
Source: press release, 5/02/13. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=761566

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SPRUCE - Double-Blind Randomized Phase II Trial of Carboplatin and Pemetrexed With or Without OGX-427 in Patients With Previously Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer (The Spruce Clinical Trial)

Estimated Enrollment: 155
Study Start Date: July 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01829113?term=ogx427&rank=4

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Apatorsen (OGX-427) NSCLCOncologyNon-Small Cell Lung Cancer (NSCLC)Hsp27 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 - 2016-12-31

Results:

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OncoGenex Announces Update on Phase 2 Spruce Trial in Previously Untreated Metastatic Non-Small Cell Lung Cancer
BOTHELL, Wash. and VANCOUVER, British Columbia, Jan. 20, 2016 /CNW/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that data from the Phase 2 Spruce™ trial evaluating the combination of apatorsen with carboplatin and pemetrexed in patients with untreated metastatic non-small cell lung cancer (NSCLC) did not reach the statistical significance required to demonstrate a progression-free survival (PFS) benefit. A potential PFS benefit was observed in patients with high baseline serum Hsp27 status when treated with apatorsen. The study is ongoing and overall survival results are expected in the second half of 2016.

Treatment and maintenance therapy with apatorsen was well tolerated. Adverse events were comparable between the arms and as expected for the study chemotherapy treatment.

"We look forward to following the Spruce study through overall survival this year to determine if apatorsen can provide a treatment benefit for this population of lung cancer patients," said principal investigator David Spigel, director, lung cancer research program and chief scientific officer for Sarah Cannon Research Institute. "Despite recent advances including exciting immunotherapies, patients with lung cancer still have a significant need for new treatment options that extend survival. Chemotherapy remains a standard of care and an important option for people with advanced disease."

Spruce is a placebo-controlled, double-blind, randomized trial sponsored and conducted by Sarah Cannon Research Institute. Approximately 155 patients with non-squamous NSCLC received either apatorsen plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy in the Spruce trial. In addition to PFS and OS, other analyses are being conducted to evaluate tumor response rates, safety, tolerability, and the effect of therapy on Hsp27 levels. Detailed results will be presented at an upcoming medical meeting.

"PFS can provide an early signal of activity in lung cancer trials, yet overall survival continues to be the benchmark for determining both clinical and regulatory significance," said Scott Cormack, President and CEO of OncoGenex. "Overall survival results from Spruce expected later this year will inform the future development of apatorsen in lung cancer. We plan to continue to evaluate a potential correlation between Hsp27 and survival benefit in this and other apatorsen trials."

Lung cancer is the most common cancer worldwide, with approximately 1.8 million new cases per year. It is the leading cause of cancer death among both men and women in the U.S., with approximately 160,000 Americans expected to die from the disease in 2016. Non-squamous histology NSCLC includes adenocarcinoma and large cell carcinoma and accounts for more than half of all diagnoses.
More
Source: press release, 1/20/16. http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=951016

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