BOTHELL, WA, USA and VANCOUVER, BC, USA I September16, 2014 I OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that patient enrollment has been completed in the Phase 3 AFFINITY trial.
The international, randomized, open-label Phase 3 AFFINITY trial is designed to evaluate the potential of custirsen to improve survival outcomes in approximately 630 men with metastatic castrate-resistant prostate cancer (CRPC). Patients have been randomized to receive second-line Jevtana® (cabazitaxel) and prednisone with or without custirsen.
“We are grateful to the AFFINITY investigators for their efforts, as well as the patients and their loved ones who are supporting this important trial. The pace of enrollment over the past six months has been a strong indication of the prostate cancer community’s ongoing interest in custirsen, particularly in more heavily treated patients, like those in the AFFINITY trial,” said Scott Cormack, President and CEO of OncoGenex. “OncoGenex’ focus is on the science that may lead one day to preventing cancer from evading treatment, and we are pursuing this approach through the ongoing Phase 3 trials of custirsen and multiple Phase 2 trials of apatorsen in four different tumor types.”
The timing of the survival primary endpoint data is event-driven and results are currently expected in late 2015 or early 2016.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the evaluation of custirsen in the AFFINITY trial. For more information on custirsen and the AFFINITY trial, please visit www.oncogenex.com.
About Custirsen
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.
As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to 294 patients with various types of cancer. The majority of adverse events were mild. The most common adverse events associated with custirsen consisted of flu-like symptoms. The most common serious adverse events (SAE) associated with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea. Each SAE event was observed in approximately 2%-4% of patients. In the Phase 3 SYNERGY trial in men with metastatic CRPC, adverse events observed were similar to custirsen’s known adverse event profile.
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. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and licensing agreement to develop and commercialize OncoGenex’ lead drug candidate, custirsen. 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: 90
BOTHELL, WA, USA and VANCOUVER, BC, USA I September16, 2014 I OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that patient enrollment has been completed in the Phase 3 AFFINITY trial.
The international, randomized, open-label Phase 3 AFFINITY trial is designed to evaluate the potential of custirsen to improve survival outcomes in approximately 630 men with metastatic castrate-resistant prostate cancer (CRPC). Patients have been randomized to receive second-line Jevtana® (cabazitaxel) and prednisone with or without custirsen.
“We are grateful to the AFFINITY investigators for their efforts, as well as the patients and their loved ones who are supporting this important trial. The pace of enrollment over the past six months has been a strong indication of the prostate cancer community’s ongoing interest in custirsen, particularly in more heavily treated patients, like those in the AFFINITY trial,” said Scott Cormack, President and CEO of OncoGenex. “OncoGenex’ focus is on the science that may lead one day to preventing cancer from evading treatment, and we are pursuing this approach through the ongoing Phase 3 trials of custirsen and multiple Phase 2 trials of apatorsen in four different tumor types.”
The timing of the survival primary endpoint data is event-driven and results are currently expected in late 2015 or early 2016.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the evaluation of custirsen in the AFFINITY trial. For more information on custirsen and the AFFINITY trial, please visit www.oncogenex.com.
About Custirsen
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.
As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to 294 patients with various types of cancer. The majority of adverse events were mild. The most common adverse events associated with custirsen consisted of flu-like symptoms. The most common serious adverse events (SAE) associated with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea. Each SAE event was observed in approximately 2%-4% of patients. In the Phase 3 SYNERGY trial in men with metastatic CRPC, adverse events observed were similar to custirsen’s known adverse event profile.
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. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and licensing agreement to develop and commercialize OncoGenex’ lead drug candidate, custirsen. 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: 90
