The company is currently enrolling a Phase 3 clinical trial referred to as SYNERGY, to be conducted in approximately 123 cancer centers to evaluate a survival benefit for custirsen in combination with first-line docetaxel treatment in approximately 800 patients with castration-resistant prostate cancer (CRPC).
Enrollment continues for the Phase 3 Prostate Cancer SATURN trial to evaluate a durable pain palliation benefit for custirsen in combination with docetaxel retreatment as second-line chemotherapy. The study will enroll approximately 300 patients with CRPC.
OncoGenex has submitted to the U.S. Food and Drug Administration (FDA) a revision to the approved Special Protocol Assessment (SPA), to expand the inclusion criteria for the SATURN trial. The proposed revision would permit participants to receive either docetaxel re-treatment or cabazitaxel as chemotherapy in the clinical study. The study design would remain the same in that all patients would be randomized to receive custirsen or placebo in conjunction with chemotherapy. In addition, the pain palliation endpoints remain unchanged.
Two additional trials are scheduled for later this year: A Phase 3 clinical trial to evaluate a survival benefit for custirsen in combination with first-line chemotherapy in patients with non-small cell lung cancer (NSCLC) and a
Phase 2 clinical trial of OGX-427 in approximately 180 patients with metastatic bladder cancer. “We recognize the prostate cancer landscape is evolving rapidly and the approval of new treatments is encouraging news for patients,” said Scott Cormack, president and chief executive officer of OncoGenex. “The proposed revision to the SATURN trial will help ensure custirsen remains aligned with currently approved chemotherapy.”
Revenue for the first quarter of 2011 decreased to $1.2 million, compared with $4.7 million for the first quarter of 2010. This decrease was due to lower reimbursement revenue earned through a strategic collaboration with Teva resulting from manufacturing costs being paid directly by Teva, as well as lower costs associated with clinical trials.
Release Date: May 9, 2011