Conference call to be held on Thursday, March 26, 2015 at 4:30 p.m. Eastern Time
BOTHELL, Wash. and VANCOUVER, British Columbia, March 26, 2015 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today provided a summary of clinical developments and announced fourth quarter and year end 2014 financial results.
Clinical Developments and Anticipated Near-term Milestones
Custirsen
- Collaboration: In December 2014, OncoGenex and Teva agreed to negotiate the termination of their collaboration and return custirsen rights to OncoGenex. Negotiations of the final termination agreement are ongoing.
- Two Phase 3 Trials: OncoGenex’ custirsen product candidate is currently being evaluated in two Phase 3 clinical trials for patients with castrate-resistant prostate cancer and non-small cell lung cancer.
- Phase 3 SYNERGY Results: Following the completion of the Phase 3 SYNERGY trial and a subsequent exploratory analysis, custirsen showed a meaningful survival benefit in men who were defined as having poor prognosis, based on well-established prostate cancer risk factors. The primary endpoint for this trial was not met.
- Phase 3 AFFINITY Trial: The ongoing AFFINITY Phase 3 trial is designed to evaluate a survival benefit for custirsen in combination with Jevtana® (cabazitaxel) treatment as second-line chemotherapy in approximately 630 men with metastatic castrate-resistant prostate cancer (CRPC). This trial is fully enrolled with results expected in late 2015/early 2016.
- Phase 3 ENSPIRIT Trial: The ongoing ENSPIRIT Phase 3 trial is evaluating a survival benefit for custirsen in combination with docetaxel treatment as second-line chemotherapy in patients with non-small cell lung cancer (NSCLC). The first futility analysis was passed in August 2014 and a second more rigorous futility analysis is planned by mid-2015, subject to completion of the Teva termination agreement and a modified statistical analysis plan.
- Prospective Evaluation: Based on the improved survival benefit observed in poor prognostic patients treated with custirsen in the completed Phase 3 SYNERGY trial, we may prospectively define and evaluate this patient population in both the AFFINITY and ENSPIRIT trials.
Apatorsen
- Five Phase 2 Trials: Apatorsen is currently being evaluated in five randomized Phase 2 trials to assess its ability to inhibit heat shock protein 27 (Hsp27) and improve treatment outcomes in bladder, lung, pancreatic and prostate cancer patients.
- Metastatic Bladder Cancer: In December 2014, the company announced results from its Phase 2 Borealis-1 trial of apatorsen in the treatment of metastatic bladder cancer. Overall trial results indicated that the addition of 600mg apatorsen to standard of care chemotherapy showed a 14 percent reduction in risk of death (overall survival hazard ratio (HR) = 0.86) and a 17 percent reduction in progressive disease and death (progression-free survival HR = 0.83) when compared to chemotherapy alone. Over one-third of the patients in the trial had lower performance status, as defined by a Karnofsky score of 80 percent or less. These patients derived the greatest benefit from 600mg apatorsen in combination with chemotherapy, resulting in a 50 percent reduction in risk of death (overall survival HR = 0.50) compared to chemotherapy alone.
- Pancreatic Cancer: In December 2014, the company announced patient enrollment was completed in the Phase 2 Rainier clinical trial evaluating apatorsen in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer.
- Lung Cancer: In February 2015, the company announced patient enrollment was completed in the Phase 2 Spruce clinical trial evaluating apatorsen in combination with carboplatin and pemetrexed in patients with previously untreated advanced NSCLC.
“In the past year, we saw progress in all seven of our ongoing Phase 2 and Phase 3 trials across a broad spectrum of oncology indications with high unmet needs,” said Scott Cormack, President and CEO of OncoGenex. “Key trial results are helping to direct our focus on the roles of custirsen and apatorsen in bladder and prostate cancer patients with poor prognostic factors, and we look forward to additional opportunities to evaluate these compounds further in these settings. We are excited about the year ahead as we anticipate a number of important clinical events in 2015 and into 2016.”
Financial Update and Results
- Revenue for the fourth quarter and year ended December 31, 2014 was $5.7 million and $27.1 million, respectively. This compares with $8.6 million and $29.9 million, respectively, in the same periods in 2013. Revenue earned in 2014 consists of reimbursable clinical trial, manufacturing and preclinical costs incurred by OncoGenex under the collaboration agreement with Teva.
- Total operating expenses for the fourth quarter and year ended December 31, 2014 were $12.3 million and $56.6 million, respectively.
- Net loss for the fourth quarter and year ended December 31, 2014 was $5.7 million, and $26.2 million, respectively.
- In Feburary 2015, the company announced the execution of new lease agreements enabling the relocation of its Bothell, Washington headquarters, yielding significant savings through 2017.
- The company had $47.1 million in cash, cash equivalents and short-term investments as of December 31, 2014, compared to $39.2 million as of December 31, 2013.
Based on current expectations, the company believes its capital resources as of December 31, 2014 will be sufficient to fund its currently planned operations into the third quarter of 2016, and through:
To read full press release, please click here.
Help employers find you! Check out all the jobs and post your resume.
