BOTHELL, WA, USA and VANCOUVER, Canada I December 9, 2015 I OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the independent Data Safety Monitoring Board (DSMB) at Dana-Farber/Harvard Cancer Center has recommended that the Phase 2 Borealis-2™ trial continue as planned after completing the pre-specified futility analysis.
Borealis-2 is evaluating apatorsen in combination with docetaxel treatment in patients with metastatic bladder cancer. It is the third clinical trial assessing the ability of apatorsen to improve outcomes for patients in this tumor type. Previously, encouraging results were observed in the Borealis-1™ trial evaluating apatorsen in combination with standard of care chemotherapy in metastatic bladder cancer, as well as a trial evaluating apatorsen as monotherapy in patients with non-muscle invasive (superficial) disease.
Investigators have concluded in the bladder cancer trials conducted to date that 600mg apatorsen administered intravenously and all apatorsen doses administered intravesically have been well tolerated. Clinical trials of apatorsen across four tumor types involving over 700 patients have been conducted or are currently ongoing with patient safety monitored throughout the course of these trials.
“We are pleased with the DSMB’s recommendation to continue the Borealis-2 trial and we look forward to final results expected in 2016,” said Scott Cormack, President and Chief Executive Officer of OncoGenex. “Additionally, early next year we will receive regulatory feedback on our apatorsen clinical trial design and development strategy for patients with non-muscle invasive bladder cancer.”
Borealis-2 is an investigator-sponsored, randomized Phase 2 trial evaluating a survival benefit with apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in approximately 200 patients with metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. The trial is being coordinated by the Hoosier Cancer Research Network at 27 sites across the United States.
Upcoming Milestones
In addition to Borealis-2, OncoGenex expects to announce progression-free survival results for the Phase 2 Spruce™ trial in the first quarter of 2016 with continued overall survival follow up.
The company’s other asset, custirsen, is currently being evaluated in two ongoing Phase 3 clinical trials. The Phase 3 ENSPIRIT trial is evaluating the ability of custirsen, in combination with docetaxel treatment as second-line chemotherapy, to extend survival in patients with metastatic NSCLC. ENSPIRIT passed a rigorous final futility survival analysis in July and the trial is continuing as planned. Based on current enrollment projections, ENSPIRIT results could be available in the second half of 2016.
The Phase 3 AFFINITY trial is evaluating the ability of custirsen, in combination with cabazitaxel as second-line chemotherapy, to extend survival in men with metastatic CRPC whose disease has progressed following treatment with docetaxel. Final results from the AFFINITY trial for the intent-to-treat population are expected in the second half of 2016.
About Bladder Cancer
Worldwide, more than 429,000 cases of bladder cancer are diagnosed each year, and nearly 75,000 cases of bladder cancer will be diagnosed in the U.S. in 2015. Approximately 70 percent of patients present with superficial or non-muscle-invasive bladder cancer, with about 30 percent of patients having locally invasive or metastatic disease at the time of diagnosis. Of patients with locally invasive disease, 50 percent will relapse with metastases within two years. Limited options exist for both first- and second-line treatment of advanced bladder cancer and there continues to be a high unmet need for additional therapeutic options for this patient population.
About Apatorsen and ORCA™
Apatorsen (OGX-427) is designed to inhibit production of heat shock protein 27 (Hsp27), disable cancer cells’ defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes. 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.
The ORCA™ (Ongoing Studies Evaluating Treatment Resistance in Cancer) program encompasses clinical trials of apatorsen. Phase 2 clinical trials are underway in bladder, lung and prostate cancers. For more information on apatorsen and ORCA, please visit www.OncoGenex.com or www.orcatrials.com.
About OncoGenex
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company’s Twitter account: https://twitter.com/OncoGenex_IR.
SOURCE: OncoGenex
Post Views: 227
BOTHELL, WA, USA and VANCOUVER, Canada I December 9, 2015 I OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the independent Data Safety Monitoring Board (DSMB) at Dana-Farber/Harvard Cancer Center has recommended that the Phase 2 Borealis-2™ trial continue as planned after completing the pre-specified futility analysis.
Borealis-2 is evaluating apatorsen in combination with docetaxel treatment in patients with metastatic bladder cancer. It is the third clinical trial assessing the ability of apatorsen to improve outcomes for patients in this tumor type. Previously, encouraging results were observed in the Borealis-1™ trial evaluating apatorsen in combination with standard of care chemotherapy in metastatic bladder cancer, as well as a trial evaluating apatorsen as monotherapy in patients with non-muscle invasive (superficial) disease.
Investigators have concluded in the bladder cancer trials conducted to date that 600mg apatorsen administered intravenously and all apatorsen doses administered intravesically have been well tolerated. Clinical trials of apatorsen across four tumor types involving over 700 patients have been conducted or are currently ongoing with patient safety monitored throughout the course of these trials.
“We are pleased with the DSMB’s recommendation to continue the Borealis-2 trial and we look forward to final results expected in 2016,” said Scott Cormack, President and Chief Executive Officer of OncoGenex. “Additionally, early next year we will receive regulatory feedback on our apatorsen clinical trial design and development strategy for patients with non-muscle invasive bladder cancer.”
Borealis-2 is an investigator-sponsored, randomized Phase 2 trial evaluating a survival benefit with apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in approximately 200 patients with metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. The trial is being coordinated by the Hoosier Cancer Research Network at 27 sites across the United States.
Upcoming Milestones
In addition to Borealis-2, OncoGenex expects to announce progression-free survival results for the Phase 2 Spruce™ trial in the first quarter of 2016 with continued overall survival follow up.
The company’s other asset, custirsen, is currently being evaluated in two ongoing Phase 3 clinical trials. The Phase 3 ENSPIRIT trial is evaluating the ability of custirsen, in combination with docetaxel treatment as second-line chemotherapy, to extend survival in patients with metastatic NSCLC. ENSPIRIT passed a rigorous final futility survival analysis in July and the trial is continuing as planned. Based on current enrollment projections, ENSPIRIT results could be available in the second half of 2016.
The Phase 3 AFFINITY trial is evaluating the ability of custirsen, in combination with cabazitaxel as second-line chemotherapy, to extend survival in men with metastatic CRPC whose disease has progressed following treatment with docetaxel. Final results from the AFFINITY trial for the intent-to-treat population are expected in the second half of 2016.
About Bladder Cancer
Worldwide, more than 429,000 cases of bladder cancer are diagnosed each year, and nearly 75,000 cases of bladder cancer will be diagnosed in the U.S. in 2015. Approximately 70 percent of patients present with superficial or non-muscle-invasive bladder cancer, with about 30 percent of patients having locally invasive or metastatic disease at the time of diagnosis. Of patients with locally invasive disease, 50 percent will relapse with metastases within two years. Limited options exist for both first- and second-line treatment of advanced bladder cancer and there continues to be a high unmet need for additional therapeutic options for this patient population.
About Apatorsen and ORCA™
Apatorsen (OGX-427) is designed to inhibit production of heat shock protein 27 (Hsp27), disable cancer cells’ defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes. 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.
The ORCA™ (Ongoing Studies Evaluating Treatment Resistance in Cancer) program encompasses clinical trials of apatorsen. Phase 2 clinical trials are underway in bladder, lung and prostate cancers. For more information on apatorsen and ORCA, please visit www.OncoGenex.com or www.orcatrials.com.
About OncoGenex
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company’s Twitter account: https://twitter.com/OncoGenex_IR.
SOURCE: OncoGenex
Post Views: 227
