OncoGenex's Prostate Cancer Compound Custirsen Gets Fast Track Designation

(RTTNews) - OncoGenex Pharmaceuticals, Inc. (OGXI) Wednesday said the U.S. Food and Drug Administration has granted Fast Track designation to the investigation of Custirsen in combination with cabazitaxel/prednisone for the treatment of men with metastatic castrate-resistant prostate cancer, following treatment using docetaxel.

Custirsen is an experimental drug designed to block the production of the protein clusterin, that may boost cancer progression rate, treatment resistance and shorter survival duration. Custirsen is designed to change tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.

The international, randomized, open-label Phase 3 Affinity Trial is for testing if Custirsen, when combined with second-line chemotherapy cabazitaxel and prednisone, can improve survival outcomes for prostrate cancer patients, when compared with second-line chemotherapy alone.

The Phase 3 trial will enroll around 630 men and is scheduled to complete enrollment in the second half of 2014.

Further, Custirsen has received Fast Track designation from the FDA for treatment of patients with metastatic non-small cell lung cancer as part of the Phase 3 Enspirit trial and for men with metastatic CRPC as part of the Phase 3 Synergy trial.

OncoGenex said the enrollment for the Enspirit trial is ongoing and top-line survival results from Synergy are expected by mid-2014.