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Apatorsen (OGX-427)

Heat Shock Protein 27: A Single Therapeutic Target with Multiple Mechanisms Leading to Treatment Resistance

Heat shock protein 27 (Hsp27) is an intracellular protein that protects cancer cells by helping them survive, leading to treatment resistance and more aggressive cancer phenotypes. Expression of Hsp27 is limited in normal cells but is elevated in many types of cancer cells making Hsp27 an attractive therapeutic target for cancer treatment.

Apatorsen: Designed To Inhibit Hsp27

Apatorsen is a once-weekly intravenous (IV) experimental drug designed to inhibit production of Hsp27 to disable cancer cells’ defenses and overcome treatment resistance. Both the potential single-agent activity and synergistic activity of apatorsen with cancer treatments may increase the overall benefit of existing therapies and augment the durability of treatment outcomes, which could lead to increased patient survival.

An Overview of Hsp27 Inhibition and the Mechanism of Action of Apatorsen

 

The ORCA™ Clinical Trial Program

ORCA

The ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) program encompasses clinical trials of apatorsen aiming to demonstrate whether inhibition of Hsp27 can lead to improved prognoses and treatment outcomes for cancer patients.

There are now a total of seven randomized Phase 2 trials for apatorsen. The ORCA program has recently expanded to encompass six of these Phase 2 trials for four tumor types.

Learn more about Apatorsen Clinical Trial Results.

Clinical Development Program

Borealis-1™: Apatorsen (OGX-427) in Metastatic Bladder Cancer

A company-sponsored, randomized, placebo-controlled Phase 2 trial of apatorsen in combination with first-line gemcitabine and cisplatin in approximately 180 patients with metastatic bladder cancer. The Borealis-1 Trial is a three-arm trial with each arm aiming to enroll 60 patients. The primary endpoint of the trial is overall survival (OS). The trial will enroll patients at sites throughout the United States, Canada and Europe.

Enrollment Completed. Learn more about the Borealis-1 Trial

OGX-427-PR01: OGX-427 in Advanced Prostate Cancer

An investigator-sponsored Phase 2 trial designed to evaluate the potential benefit of apatorsen plus prednisone in patients with CRPC. The trial will assess the number of patients who are without disease progression at 12 weeks post trial treatment and will also measure the effect of apatorsen on PSA, measurable disease, CTCs and other secondary endpoints. This trial is supported by the British Columbia Cancer Agency. Preliminary data was presented at ASCO Genitourinary Cancer Symposium in February 2012.

Learn more about the results of this trial.

OGX-427-BL01: Apatorsen (OGX-427) in Superficial Bladder Cancer

An investigator-sponsored Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of apatorsen when administered directly into the bladder of patients with superficial bladder cancer.

Learn more about the results of this trial.

Pacific™: Apatorsen (OGX-427) in Advanced Prostate Cancer

An investigator-sponsored, randomized Phase 2 trial evaluating apatorsen in approximately 80 men with metastatic castrate-resistant prostate cancer (CRPC) who are experiencing rising prostate-specific antigen (PSA) while receiving Zytiga® (abiraterone acetate). The primary endpoint of the trial is progression-free survival (PFS) at a milestone Day 60 assessment. Other secondary endpoints such as PSA and objective responses, time to disease progression, circulating tumor cell counts (CTCs), and heat shock protein 27 (Hsp27) levels also will be evaluated. The trial will enroll patients in the United States and Canada.

See results

Borealis-2™: Apatorsen (OGX-427) in Metastatic Bladder Cancer

An investigator-sponsored, randomized Phase 2 trial evaluating apatorsen in combination with docetaxel treatment in approximately 200 patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. The primary endpoint of the trial is overall survival (OS).

Enrollment completed. Learn more about Borealis-2

Spruce™: Apatorsen (OGX-427) in Advanced Non-Squamous, Non-Small Cell Lung Cancer (NSCLC)

An investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination with carboplatin and pemetrexed in approximately 155 patients with previously untreated, advanced, non-squamous NSCLC. The trial will randomize patients to receive either apatorsen or placebo in combination with carboplatin and pemetrexed therapy. The primary endpoint of the trial is progression-free survival (PFS) with additional analyses to evaluate overall survival (OS), tumor response rates, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.

Learn more about Spruce

Rainier™: Apatorsen in Metastatic Pancreatic Cancer

An investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in approximately 130 patients with previously untreated metastatic pancreatic cancer. The trial will randomize patients to receive either apatorsen or placebo in combination with Abraxane and gemcitabine therapy. The primary endpoint of the trial is overall survival (OS) with additional analyses to evaluate progression-free survival (PFS), tumor response rates, safety, tolerability and the effect of therapy on heat shock protein 27 (Hsp27) levels.

Enrollment Completed. Learn more about the Rainier Trial

Spruce-2™: Apatorsen (OGX-427) in Advanced Squamous, Non-Small Cell Lung Cancer (NSCLC)

An investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in combination with gemcitabine and carboplatin in approximately 140 patients with previously untreated, advanced, squamous NSCLC. The trial will randomize patients to receive either apatorsen plus gemcitabine and carboplatin therapy, or gemcitabine and carboplatin therapy alone. The primary endpoint will be progression-free survival (PFS), with secondary endpoints to evaluate tumor response rates, overall survival (OS), safety, tolerability, and health-related quality of life.

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