Date: 2016-02-04
Type of information: Restructuring
Compound:
Company: OncoGenex Pharmaceuticals (USA - WA)
Therapeutic area:
Type agreement: restructuring
Action mechanism:
Disease:
Details: * On February 4, 2016, OncoGenex Pharmaceuticals announced that it is implementing a plan to reduce operating expenses, including a workforce reduction of approximately 27%. The Company expects cost savings associated with the reduction of employees and consultants, together with the elimination of certain planned expenditures not required for the completion of ongoing trials, will extend cash runway into the third quarter of 2017. OncoGenex will remain focused on executing clinical development plans in order to reach several near-term milestones for both the custirsen and apatorsen programs. 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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