Shares of OncoGenex Pharmaceuticals, Inc. (OGXI) tumbled 60.3% after it announced that its lead candidate, custirsen, failed to meet its primary endpoint in the phase III, SYNERGY study.
SYNERGY, a phase III study on custirsen, evaluated the survival benefit of the candidate, in combination with first-line Taxotere, in men with metastatic castrate-resistant prostate cancer (CRPC). OncoGenex recently reported top-line results from the SYNERGY study. The detailed analysis is in progress.
The SYNERGY study missed the primary endpoint of a statistically significant improvement in overall survival in men with metastatic CRPC, compared to Taxotere alone.
We note that in Dec 2009, OncoGenex entered into a collaboration agreement with Teva Pharmaceutical Industries, Ltd. (TEVA) for the development and global commercialization of custirsen.
Custirsen enjoys Fast Track designation in the U.S. for the treatment of progressive metastatic prostate cancer in combination with Taxotere.
The failure to achieve the primary endpoint is disappointing news for OncoGenex, considering that custirsen is the most advanced candidate in its pipeline. However, investor focus will remain on the two other phase III studies evaluating custirsen, namely, ENSPIRIT and AFFINITY.
ENSPIRIT is conducted in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The study is evaluating the potential survival benefit of custirsen plus Taxotere as second-line chemotherapy. The AFFINITY study is evaluating the overall survival benefit of custirsen plus Jevtana as second-line chemotherapy in patients with metastatic CRPC. OncoGenex expects to complete enrollment in this study by the end of 2014.
OncoGenex carries a Zacks Rank #2 (Buy). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Alexion Pharmaceuticals, Inc. (ALXN) and Gilead Sciences Inc. (GILD), both carrying a Zacks Rank #1 (Strong Buy).
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