OncoGenex Pharmaceuticals receives grant funding for Phase 2 clinical trial of OGX-427

Jan 6 2010

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), today announced that a randomized, controlled, investigator-sponsored Phase 2 clinical trial evaluating OGX-427 when administered as a monotherapy to patients with castrate resistant prostate cancer (CRPC) has received grant funding. The funds were awarded by a third party granting agency to Dr. Kim Chi, a medical oncologist at the BC Cancer Agency, Research Scientist at the Vancouver Prostate Centre and the principal investigator of the OGX-427 Phase 2 trial.

The randomized, controlled Phase 2 study will enroll up to 72 patients and is designed to determine the potential benefit of OGX-427 by evaluating the number of patients who are without disease progression at 12 weeks post study treatment with or without OGX-427. This Phase 2 trial will also measure the direct effect of OGX-427 on PSA levels, time to progression by PSA or measurable disease, numbers of circulating tumor cells (CTCs) and other relevant secondary endpoints. The trial is expected to start by mid 2010 following final analysis of Phase 1 data and approval by Health Canada and the institutional review board. As previously reported, a Phase 1 trial of OGX-427 administered systemically as a single agent to patients with various solid tumors showed reductions in tumor markers associated with prostate and ovarian cancer as well as reductions in total circulating tumor cells.

OGX-427 is a second-generation antisense drug that is designed to reduce production of Heat Shock Protein 27 (Hsp27), a cell-survival protein that inhibits treatment-induced cell death through multiple pathways, including the androgen receptor (AR). Preclinical studies have shown that androgen bound to the AR on prostate tumor cells induces rapid Hsp27 phosphorylation that in turn enhances AR activity and prostate cancer cell survival. OGX-427-induced knockdown of Hsp27 led to AR degradation, decreased PSA levels, and delayed progression of castration resistant prostate tumors.

"The results from our Phase 1 program supports the development of OGX-427 in a number of solid tumors. This grant-funded Phase 2 trial in prostate cancer complements a separate ongoing clinical investigation of OGX-427 in bladder cancer funded by the National Cancer Institute of Canada. We are also considering a randomized Phase 2 clinical trial investigating OGX-427 in ovarian cancer," said Scott Cormack, President and Chief Executive Officer of OncoGenex. "The OGX-427 trials in prostate and bladder cancer are consistent with our strategy to advance our pipeline with minimal impact on our burn rate."

"The reduction in circulating tumor cells and tumor markers seen during a previously reported Phase 1 study of OGX-427 administered as a single agent has been very encouraging," said Dr. Kim Chi. "Given the well-tolerated safety profile for OGX-427 and the limited number of proven systemic therapeutic options for CRPC, demonstration of clinical benefit for single-agent OGX-427 would be an important alternative therapy for patients."

"This Phase 2 trial of OGX-427 is designed to confirm the pre-clinical observations that OGX-427 inhibits multiple Hsp27-regulated pathways that enhance prostate tumor cell survival," said Dr. Martin Gleave, Chief Scientific Officer at OncoGenex, and Distinguished Professor of Urologic Sciences at University of British Columbia. "Targeting Hsp27 as a therapy is attractive as it suppresses many pathways implicated in cancer progression and resistance, including the AR which is of critical importance in CRPC, as opposed to targeting of a single pathway which might be expected to have limited benefits."