OncoGenex Pharmaceuticals, Inc. OGXI announced that the independent Data Safety Monitoring Board has recommended continuation of phase II Borealis-2 study on apatorsen, after it completed the pre-specified futility analysis.
The investigator-sponsored, randomized study will evaluate apatorsen in combination with Taxotere (docetaxel) treatment compared to Taxotere as monotherapy, in patients with metastatic bladder cancer who experienced disease progression following first-line platinum-based chemotherapy. Data readout is expected in 2016.
Apatorsen is also being evaluated in combination with Paraplatin (carboplatin) and Alimta (pemetrexed) compared to Paraplatin plus Alimta in the phase II Spruce study in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC). Results from the study are expected in the first quarter of 2016.
In addition, apatorsen is in the phase II Pacific study evaluating men with castrate-resistant prostate cancer (CRPC) who are experiencing a rising prostate specific antigen while receiving Zytiga. Patient enrollment is expected to complete in the first quarter of 2017.
According to the American Cancer Society, in 2015, about 74,000 new cases of bladder cancer are expected to be diagnosed in the U.S.
We remind investors that the company received a setback related to the phase II Borealis-1 study. Data revealed that the survival outcome was impacted by the prognostic risk factors like Karnofsky Performance Status, liver involvement, low hemoglobin and high alkaline phosphatase.
Meanwhile, OncoGenex continues to progress with its pipeline. Currently, the company is evaluating custirsen in combination with Taxotere treatment as second-line chemotherapy in the phase III ENSPIRIT study for the treatment of patients with metastatic NSCLC. Custirsen is also in the phase III AFFINITY study in combination with Jevtana (cabazitaxel) as second-line chemotherapy for the treatment of men with metastatic CRPC whose disease progressed following treatment with Taxotere. Results from both studies are expected in the second half of 2016.
OncoGenex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Anika Therapeutics Inc. ANIK and Corcept Therapeutics Incorporated CORT, each sporting a Zacks Rank #1 (Strong Buy).
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