Shares of OncoGenex Pharmaceuticals, Inc. OGXI were down 41% after the company announced disappointing data from its late-stage trial, AFFINITY, on custirsen in men with metastatic castrate-resistant prostate cancer (CRPC) whose disease has progressed after treatment with docetaxel.
Final analysis of the phase III trial showed that the candidate has failed to meet the primary endpoint of a statistically significant improvement in overall survival in patients treated with custirsen in combination with cabazitaxel/prednisone, compared to cabazitaxel/prednisone alone.
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The results were a major blow to the company as custirsen is the only late-stage candidate in OncoGenex’s pipeline. Naturally, successful development of the candidate is crucial for the company’s growth prospects, given that it does not have any approved product in its portfolio yet. Consequently, OncoGenex plans to initiate discussions with the FDA to evaluate options for another phase III trial, ENSPIRIT, on custirsen, in combination with docetaxel, as second-line chemotherapy in patients with non-small cell lung cancer. The trial has already completed enrolment and hence an early analysis will help the company determine the path going forward and conserve resources.
Meanwhile, OncoGenex is exploring strategic alternatives for its business and has engaged MTS Health Partners, LP as its advisor to assist with the same. Apart from custirsen, other candidates in the company’s oncology pipeline include apatorsen (phase II) and OGX-225 (pre-clinical development).
Investors interested in the health care sector may consider stocks like Pacira Pharmaceuticals, Inc. PCRX, Corcept Therapeutics Incorporated CORT and ANI Pharmaceuticals, Inc. ANIP. All three stocks sport a Zacks Rank #1 (Strong Buy).
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