OGX-427
An Overview of Heat Shock Protein 27 (Hsp27) Inhibition and the Mechanism of Action of OGX-427
OGX-427 is designed to inhibit Heat Shock Protein 27 (HSP27), a cell-survival protein found at elevated levels in many human cancers including prostate, bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is thought to be an important factor leading to the development of treatment resistance and is associated with negative clinical outcomes in patients with various tumor types.
The “ORCA” (Ongoing studies evaluating treatment Resistance in CAncer) program encompasses clinical studies of OGX-427, aiming to demonstrate that inhibition of Hsp27 can lead to improved prognosis and treatment outcomes for cancer patients.
Learn more about OGX-427 Clinical Trial Results.
Clinical Development Program
Borealis-1: OGX-427 in Metastatic Bladder Cancer
Study Design: A randomized Phase 2 trial designed to evaluate the potential survival benefit, safety and tolerability of combining OGX-427 with Gemcitabine and Cisplatin in patients with advanced bladder cancer. This study will enroll approximately 180 patients who have not previously been treated with chemotherapy for metastatic disease and who are not candidates for potentially curable surgery or radiotherapy. The study will be conducted at approximately 45 cancer centers throughout North America and Europe.
Borealis-2: OGX-427 in Metastatic Bladder Cancer
Study Design: An investigator-sponsored, randomized, controlled Phase 2 study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy. This study will randomize approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone. Borealis-2 will be conducted at approximately 30 sites in the U.S. and is being sponsored by the Hoosier Oncology Group.
OGX-427-BL01: OGX-427 in Superficial Bladder Cancer
Study Design: An investigator sponsored Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of OGX-427 when administered directly into the bladder of patients with superficial bladder cancer.
Pacific: OGX-427 in Advanced Prostate Cancer
Study Design: An investigator sponsored randomized Phase 2 trial designed to evaluate the potential benefit of OGX-427 plus Zytiga® (abiraterone acetate) in men with CRPC. The aim of the study is to determine if adding OGX-427 to Zytiga plus prednisone treatment can reverse or delay treatment resistance versus continuing treatment with Zytiga plus prednisone alone. The study will assess progression-free survival (PFS) rate at 60 days after adding OGX-427 for patients who are being treated with Zytiga and have evidence of a rising PSA but no evidence of symptomatic or radiographic progression. Secondary objectives include comparing the treatment arms for PSA responses, objective responses, time to progression, CTCs and other biomarkers. This study will be conducted at approximately 15 sites in the US and Canada and is being managed by the Hoosier Oncology Group.
OGX-427-PR01: OGX-427 in Advanced Prostate Cancer
Study Design: An investigator sponsored Phase 2 trial designed to evaluate the potential benefit of OGX-427 plus prednisone in patients with CRPC. The study will assess the number of patients who are without disease progression at 12 weeks post study treatment and will also measure the effect of OGX-427 on PSA, measurable disease, CTCs and other secondary endpoints. This study is supported by the British Columbia Cancer Agency.
Preliminary data was presented at ASCO Genitourinary Cancer Symposium in February 2012.
Spruce:OGX-427 in Advanced Non-Squamous, Non-Small Cell Lung Cancer (NSCLC)
Study Design: An investigator-sponsored, randomized, double-blind, placebo controlled Phase 2 study evaluating OGX-427 in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC). The trial will enroll approximately 155 patients and will investigate whether adding OGX-427 to carboplatin and pemetrexed therapy can extend progression-free survival outcomes. This trial is being sponsored by the Sarah Cannon Research Institute (SCRI) and will be conducted at 20 SCRI sites throughout North America.
Cedar: OGX-427 In Advanced Squamous Non-Small Cell Lung Cancer (NSCLC)
Study Design: An investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in combination with gemcitabine and carboplatin in patients with previously untreated, advanced, squamous, non-small cell lung cancer (NSCLC). The trial will enroll approximately 140 patients and will investigate whether adding OGX-427 to gemcitabine and carboplatin therapy can extend progression-free survival (PFS) outcomes. This trial is being conducted by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will involve 35 centres in the UK.
Rainier: OGX-427 in Metastatic Pancreatic Cancer
Study Design: An investigator-sponsored, randomized, double-blind, placebo controlled Phase 2 study evaluating the potential survival benefit of adding OGX-427 to ABRAXANE® plus Gemcitabine in approximately 130 patients with previously untreated metastatic Pancreatic Cancer. The trial is being sponsored by the Sarah Cannon Research Institute (SCRI) and will be conducted at 12 SCRI sites in the United States.
This section is intended specifically for healthcare professionals. Information is provided for educational use only, based on pre-clinical and clinical data of OGX-427.
OGX-427 is not approved for commercial use and is only available for investigational use in approved clinical trials.
