OncoGenex Pharmaceuticals (OGXI)
Q3 2012 Earnings Call
November 08, 2012 4:30 pm ET
Scott Daniel Cormack - Founder, Chief Executive Officer, President and Director
Michelle G. Burris - Chief Financial Officer, Principal Accounting Officer, Executive Vice President of Operations, Treasurer and Secretary
Cindy Jacobs - Chief Medical Officer and Executive Vice President
Y. Katherine Xu - William Blair & Company L.L.C., Research Division
Stephen Willey - Stifel, Nicolaus & Co., Inc., Research Division
Philippa Flint - Bloom Burton & Co., Research Division
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Thank you, and thanks, everyone, for joining us today. With me from OncoGenex are Scott Cormack, Chief Executive Officer; and Michelle Burris, Chief Financial Officer. Also on the call is Cindy Jacobs, Chief Medical Officer; and Jaime Welch, VP of Marketing and Corporate Communications.
Before we begin, I'd like to remind everyone that today's call contains forward-looking statements based on current expectations. These statements are only predictions, and actual results may vary materially from those projected. So 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 provide an overview of the development opportunities and activities for our 2 clinical-stage product candidates, custirsen and OGX-427.
Scott Daniel Cormack
Good afternoon, and thank you for joining us. I'd like to begin today's call with an update on the custirsen development program and the significant progress we've made in the third quarter. Earlier this week, we announced completion of patient enrollment in SYNERGY, our Phase III primary registration trial for custirsen. As a reminder, SYNERGY is designed to evaluate the survival benefit for custirsen when added to the first-line chemotherapy, docetaxel, in men with metastatic castrate-resistant prostrate cancer or CRPC. The target accrual for SYNERGY has been achieved and over 1,000 men are now enrolled. This is truly an important milestone for OncoGenex and for the custirsen program. Completing accrual advances our goal of making custirsen available to men, who are in need of new treatment options for advanced prostate cancer.
I'd like to applaud the efforts of the OncoGenex and Teva SYNERGY teams and the clinicians and staff at the 142 trial locations throughout North America and Europe. I'd also like to express my appreciation to the patients who are participating in this study.
As we've discussed before, custirsen has received fast-track designation and the SYNERGY study is under an SPA agreement with the FDA. We continue to expect data results by the end of June 2013. However, the endpoint for SYNERGY is event driven and may occur later than predicted.
In addition to completing enrollment in SYNERGY in the third quarter, we initiated patient enrollment in 2 other Phase III custirsen studies, AFFINITY and ENSPIRIT. AFFINITY is our Phase III clinical study evaluating an overall survival benefit of custirsen when combined with Jevtana, a second-line chemotherapy for patients with CRPC. The study is now enrolling with a target accrual of approximately 630 men throughout North America, Europe, Russia and Australia. The ENSPIRIT study is designed to evaluate the potential survival benefit of combining custirsen with docetaxel in approximately 1,100 patients with advanced metastatic non-small cell lung cancer, who have progressed after first-line chemotherapy has failed.
I'd now like to provide a brief update on OGX-427, our product candidate that is designed to reduce levels of Heat Shock Protein 27 or Hsp27. Preliminary data from the investigator-sponsored Phase II clinical trial of OGX-427 in chemotherapy-naive patients with metastatic CRPC were recently presented at the European Society for Medical Oncology Annual Meeting in Vienna. Consistent with previous data reported, the results showed a higher number of patients without disease progression at 12 weeks and greater declines in prostate-specific antigen and circulating tumor cells with OGX-427 plus prednisone treatment compared to prednisone alone. The study has completed enrollment of 74 patients and we expect final data to be presented next year.
As previously announced, an investigator-sponsored randomized Phase II study evaluating OGX-427 in combination with Zytiga in patients with CRPC is expected to initiate in the coming months. In addition, we continue to enroll patients to our randomized Phase II clinical trial of OGX-427 patients with metastatic bladder cancer. This trial will evaluate the overall survival benefit of OGX-427 in combination with gemcitabine and cisplatin and aims to enroll approximately 180 patients throughout North America and Europe. We look forward to providing updates in the near future as these studies progress, as well as on our additional plans for OGX-427 in other malignancies.
As I stated in my opening remarks, we have made significant progress in the third quarter. It has been a long road and custirsen is now in the final stretch. With SYNERGY now fully enrolled, our accrual risk of our primary registration study is now behind us. We also now have 2 additional Phase III custirsen studies enrolling, as well as robust and fully funded development plan for OGX-427. We're excited about the momentum we have gained for both of these novel mechanisms. In the field of cancer drug development, custirsen and OGX-427 are unique in that they both have combinability potential with various agents and they also both work by overcoming treatment resistance, which remains a primary concern for clinicians, patients with cancer and their families. At this time, I'll turn the call over to Michelle, who will provide an overview of the third quarter financial results. Michelle?