OncoGenex Pharmaceuticals (OGXI)
Q4 2012 Earnings Call
March 07, 2013 4:30 pm ET
Scott Daniel Cormack - Founder, Chief Executive Officer, President, Principal Financial Officer, Treasurer, Secretary and Director
Susan Wyrick - Principal Accounting Officer
Chad J. Messer - Needham & Company, LLC, Research Division
Stephen D. Willey - Stifel, Nicolaus & Co., Inc., Research Division
Philippa Flint - Bloom Burton & Co., Research Division
Howard Liang - Leerink Swann LLC, Research Division
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Thank you, and thanks, everyone, for joining us. With me today from OncoGenex are Scott Cormack, Chief Executive Officer; and Susan Wyrick, Principal Accounting Officer. Also on the call are Cindy Jacobs, Chief Medical Officer; Michelle Burris, Executive VP of Operations; and Jaime Welch, VP of Marketing and Corporate Communications.
Before we begin, I'd like to remind everyone that today's conference call contains forward-looking statements based on current expectations. These statements are only predictions, and actual results may vary materially from those projected. Please refer to OncoGenex's documents filed with the SEC concerning factors that could affect the company, copies of which are available on the website.
I'll now turn the call over to Scott who will review key highlights from 2012 and provide an update on our 2 clinical-stage product candidates, custirsen and OGX-427.
Scott Daniel Cormack
Thanks, Susan. Good afternoon, and thank you for joining us. I'd like to begin today's call reviewing the progress we've made on the custirsen development program in 2012. In the fourth quarter, we announced the completion of patient enrollment in SYNERGY, our Phase III primary registration trial for custirsen. SYNERGY is designed to evaluate the survival benefit for custirsen when added to the first-line chemotherapy, docetaxel, in men with metastatic castrate-resistant prostate cancer, or CRPC. Over 1,000 men are now enrolled in the SYNERGY trial in approximately 142 cancer centers throughout North America and Europe. Custirsen has received Fast Track designation, and the SYNERGY trial is under an SPA agreement with the FDA. As we have previously discussed, the expected timing of results is based on a prespecified number of death events that we continue to project to occur in the fourth quarter of 2013. We expect data results to be announced in the first half of 2014.
In the third quarter of 2012, we initiated patient enrollment in 2 additional Phase III custirsen studies, AFFINITY and ENSPIRIT. AFFINITY is our Phase III clinical study evaluating an overall survival benefit of custirsen when combined with cabazitaxel or Jevtana, a second-line chemotherapy for patients with CRPC. The study is being conducted throughout North America, Europe, Russia and Australia with the target accrual of approximately 630 men. And finally, the ENSPIRIT trial continues to enroll patients with advanced or metastatic non-small cell lung cancer who has progressed after first-line chemotherapy has failed. ENSPIRIT is designed to evaluate the potential survival benefit of combining custirsen with docetaxel in approximately 1,100 patients. We are pleased to announce that custirsen has recently received Fast Track designation from the FDA in the patient population being evaluated in the ENSPIRIT trial.
Recently, there have been numerous changes and paradigm shifts across the prostate cancer treatment landscape. This means more options for physicians as the armamentarium to treat CRPC patients expands. As new studies are initiated and data emerge, the debate will continue on sequencing of new antiandrogens and the incorporation of radiopharmaceuticals into treatment practice. Regardless of this evolution, as patients become symptomatic, we believe chemotherapy will continue to be a mainstay in the treatment landscape. We're confident that custirsen is poised for success as a potential partner therapy to docetaxel and cabazitaxel.
I'd now like to provide an update on our significant clinical development programs for our proprietary agent, OGX-427. As you may recall, in 2012, preliminary Phase II data on OGX-427 in chemotherapy-naive CRPC patients were presented. Investigator-sponsored study showed activity in CRPC by demonstrating promising results. There were fewer patients without disease progression, greater declines in PSA and circulating tumor cells in the group receiving OGX-427 plus prednisone treatment compared to those receiving prednisone alone.
Based on these findings and the potential role for OGX-427 in prostate cancer, in December, we announced the initiation of the Pacific study. Pacific is an investigator-sponsored randomized Phase II study evaluating OGX-427 in combination with abiraterone acetate, or Zytiga, with patients with CRPC. Approximately 80 men who are being treated with Zytiga and have evidence of rising PSA, who have no evidence of symptomatic or radiographic progression, will be randomized to either continued treatment with Zytiga and prednisone or have OGX-427 added. Patients can be enrolled to the study regardless if they have received prior chemotherapy or not and will continue on the study until symptomatic, radiographic or other documented disease progression occurs. The primary objective will be to determine whether the addition of OGX-427 can extend the benefit of Zytiga by delaying or reversing treatment resistance. The rationale for Pacific is based on the idea that cancer cells use adaptive pathways to escape and proliferate, resulting in resistance to treatment. OGX-427 and Zytiga are potentially synergistic because they disrupt androgen receptor signaling pathways in different ways. The study is being conducted in partnership with the Hoosier Oncology Group and is currently enrolling in the United States and Canada.