Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These companies spend a significant amount in advancing their pipelines. One such biopharma company is OncoGenex Pharmaceuticals, Inc. (OGXI) whose pipeline includes custirsen, apatorsen (OGX-427) and OGX-225.
Custirsen is the most advanced candidate in the pipeline. Recently, OncoGenex announced that the number of pre-determined events required for final analysis of custirsen has been reached in the phase III SYNERGY study.
The primary endpoint of the study will evaluate the overall survival benefit of the candidate, in combination with Sanofi’s (SNY) Taxotere as first-line chemotherapy, in metastatic castrate-resistant prostate cancer (:CRPC) patients.
OncoGenex expects final survival data from the study by mid 2014.
OncoGenex and partner Teva Pharmaceutical Industries, Ltd. (TEVA) are blinded to all data from the SYNERGY trial. We note that in Dec 2009, OncoGenex entered into a collaboration agreement with Teva for the development and global commercialization of custirsen.
Custirsen received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with Taxotere.
Custirsen is in two other phase III studies, 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 Sanofi’s Jevtana (cabazitaxel) 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 #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider Endocyte Inc (ECYT), which carries a Zacks Rank #1 (Strong Buy).