The U.S. Food and Drug Administration (FDA) granted Fast Track
OncoGenex Pharmaceuticals, Inc
) 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
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.
Sucampo Pharmaceuticals, Inc.
). Questcor and Sucampo carry a Zacks Rank #1 (Strong Buy), while
Amgen carries a Zacks Rank #2 (Buy).
AMGEN INC (AMGN): Free Stock Analysis Report
ONCOGENEX PHARM (OGXI): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
SUCAMPO PHARMAC (SCMP): Free Stock Analysis
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