OncoGenex Gains Fast Track Status for Custirsen - Analyst Blog

The U.S. Food and Drug Administration (FDA) granted Fast Track status to OncoGenex Pharmaceuticals, Inc.'s OGXI oncology candidate, custirsen. The Fast Track status was granted to custirsen in the AFFINITY study which is evaluating the overall survival benefit of custirsen plus Jevtana/prednisone as second-line chemotherapy in men with metastatic castrate-resistant prostate cancer (CRPC).

OncoGenex's pipeline includes custirsen, apatorsen (OGX-427) and OGX-225. Custirsen is the most advanced candidate in the pipeline. Custirsen is in three phase III studies.

The open-label, randomized, phase III AFFINITY study will evaluate the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone. OncoGenex expects to complete enrollment of 630 men in this study in the second half of 2014.

SYNERGY, a phase III study on custirsen, is evaluating the survival benefit of the candidate, in combination with first-line Taxotere, in men with metastatic CRPC. The pre-specified number of events required for final analysis of this study was reached recently. Top-line survival results are expected by mid 2014.

Custirsen is in another phase III study – ENSPIRIT – which is being conducted in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The study will evaluate the potential survival benefit of custirsen plus Taxotere as second-line chemotherapy. The study is currently enrolling patients.

Custirsen received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with Taxotere and also for the treatment of patients with metastatic non-small cell lung cancer.

OncoGenex does not have any marketed product in its portfolio. We expect investor focus to remain on custirsen.

OncoGenex carries a Zacks Rank #2 (Buy). Other well-placed stocks that look attractive in the biopharma sector include Questcor Pharmaceuticals, Inc. QCOR, Amgen AMGN and Sucampo Pharmaceuticals, Inc. SCMP. Questcor and Sucampo carry a Zacks Rank #1 (Strong Buy), while Amgen carries a Zacks Rank #2 (Buy).