OncoGenex Pharmaceuticals, Inc, announced that the first patient has been dosed in an open label, dose-escalation, phase-1 clinical trial evaluating OGX-427 when administered directly into the bladder in patients with bladder cancer. This trial is separate from an ongoing phase-1 trial of OGX-427 administered systemically in patients with various solid tumours. 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 apoptotic cell death through multiple pathways.

The study, which will enrol up to 36 patients with bladder cancer, is designed to determine the safety and potential benefit of OGX-427 administered directly into the bladder using a catheter, which is called intravesical instillation. In addition, the study will measure the direct effect of OGX-427 on expression of Hsp27 in bladder tumour cells as well as determine the pharmacokinetics and pharmacodynamics of OGX-427 when delivered by intravesical instillation. The study is sponsored by the National Cancer Institute of Canada (NCIC). Dr Alan So, an assistant professor in the Department of Urologic Sciences at the University of British Columbia and Research Scientist at the Vancouver Prostate Centre, is the study's principal investigator.

"The current treatment for superficial bladder cancer is local resection with immunotherapy, which often has significant local and systemic side effects," said Dr So. "Because of the limitations of current adjuvant options, a treatment option like intravesical delivery of OGX-427 that is specifically targeted to the tumour would be desirable."

"This phase-1 trial of OGX-427 is an attractive trial design as removal of bladder tumour samples after treatment allows us to demonstrate inhibition of Hsp27 expression at the cellular level in the tumour," said Scott Cormack, president and chief executive officer of OncoGenex.

"By conducting this trial through an investigator-sponsored trial with leading clinical researchers at the Vancouver Prostate Centre allows us to advance the development of OGX-427 without a significant commitment of our financial resources," Cormack added.

In preclinical studies conducted by the Vancouver Prostate Centre, OGX-427 had single-agent activity in multiple cancers. In preclinical models of bladder cancer, the investigators observed that bladder cancer tumours were significantly smaller six weeks after OGX-427 administration compared to the control group.

OGX-427 is designed to reduce production of Hsp27, a protein that is over-produced in response to many cancer treatments including hormone ablation therapy, chemotherapy and radiation therapy.

OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address unmet needs in the treatment of cancer.