Wednesday, bio-pharmaceutical company OncoGenex Pharmaceuticals, Inc. (OGXI) said that the Phase 2 clinical trial evaluating OGX-427, when administered as a monotherapy to patients with castrate resistant prostate cancer, has received grant funding.
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.
OGX-427 is also being evaluated in a separate Phase 1 clinical trial for the systemic treatment of solid tumors including prostate, non-small cell lung, breast, ovarian, and bladder cancers.
OncoGenex said 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 and other relevant secondary endpoints.
The trial is expected to begin by mid 2010 following final analysis of Phase 1 data and approval by Health Canada and the institutional review board.
"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."
OGXI closed Tuesday's regular trading session at $21.33.
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