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OncoGenex's AFFINITY on Track, Passes Futility Analysis - Analyst Blog

OncoGenex Pharmaceuticals, Inc. (OGXI) announced that a phase III study (AFFINITY) on custirsen has passed the interim futility analysis and is continuing as per the recommendation of the Independent Data Monitoring Committee.

The AFFINITY study is evaluating the survival benefit of custirsen when administered in combination with second-line Jevtana chemotherapy in patients suffering from metastatic castrate-resistant prostate cancer (CRPC). Final survival data from the study should be out in late 2015 or early 2016.

OncoGenex believes that positive results from the interim futility analysis will be a major boost for the development of custirsen. It reveals custirsen’s potential as a cancer treatment, especially in patients whose disease has progressed despite prior treatment.

We remind investors that in Dec 2014, OncoGenex executed an initial agreement with Teva Pharmaceuticals Industries, Ltd. (TEVA) to retrieve all rights pertaining to custirsen. The company had cited the shift of Teva’s focus away from oncology-related research as the reason behind regaining rights to custirsen.

Currently, custirsen (in combination with Taxotere) is also being evaluated in the phase III ENSPIRIT study as second-line chemotherapy for non small cell lung cancer (NSCLC). A second interim futility analysis of the study is scheduled for the first half of 2015. Custirsen enjoys fast track designation in the U.S. for the second-line treatment of metastatic CRPC in combination with Jevtana and prednisone, and advanced NSCLC in combination with Taxotere in patients with disease progression following the first-line treatment.

OncoGenex carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical sector are Lannett Company, Inc. (LCI) and Endo International plc (ENDP). While Endo carries a Zacks Rank #1 (Strong Buy), Lannett holds a Zacks Rank #2 (Buy).


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