BOTHELL, WA, USA and VANCOUVER, Canada I February 11, 2014 I OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the pre-specified number of events required for final analysis of the Phase 3 SYNERGY trial has been reached.
The primary efficacy endpoint of SYNERGY will analyze overall survival benefit for custirsen in combination with standard first-line docetaxel chemotherapy and prednisone in men with metastatic castrate-resistant prostate cancer (mCRPC). Overall survival results will remain blinded until all study data have been thoroughly reviewed and prepared for final analysis.
“The conclusion of SYNERGY represents a critical milestone for OncoGenex and the custirsen development program,” said Scott Cormack, President and CEO of OncoGenex. “Our teams are working diligently in order to announce survival results as soon as they are available, and we sincerely appreciate the support of the investigators, and most importantly, the men and their families who participated in this important trial.”
There have been 1,022 men enrolled into SYNERGY at 148 cancer centers throughout North America, Europe, Israel and South Korea. SYNERGY completed enrollment in 2012 and final survival results are expected to be announced by mid-2014. In the investigational arm of the trial, custirsen was administered as a weekly infusion of 640 mg following three loading doses, in combination with docetaxel and prednisone given as 3-week cycles. Patients in the comparator arm received docetaxel and prednisone without custirsen. In both arms, patients were treated until disease progression, unacceptable toxicity, or completion of up to 10 cycles, unless additional cycles were deemed beneficial by the treating physician.
Custirsen received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel/prednisone. The FDA also agreed on the design of the SYNERGY trial via the Special Protocol Assessment process.
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 and has shown potential anti-tumor benefit. The most common grade 3 and grade 4 adverse events in patients on custirsen included fatigue, neutropenia, dyspnea, thrombocytopenia, anemia, febrile neutropenia and nausea. The adverse event profile and clinical benefit for custirsen will be further defined by the results from the Phase 3 clinical trials.
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 license 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 currently being evaluated in seven randomized Phase 2 trials for a variety of cancers 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: 211
BOTHELL, WA, USA and VANCOUVER, Canada I February 11, 2014 I OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the pre-specified number of events required for final analysis of the Phase 3 SYNERGY trial has been reached.
The primary efficacy endpoint of SYNERGY will analyze overall survival benefit for custirsen in combination with standard first-line docetaxel chemotherapy and prednisone in men with metastatic castrate-resistant prostate cancer (mCRPC). Overall survival results will remain blinded until all study data have been thoroughly reviewed and prepared for final analysis.
“The conclusion of SYNERGY represents a critical milestone for OncoGenex and the custirsen development program,” said Scott Cormack, President and CEO of OncoGenex. “Our teams are working diligently in order to announce survival results as soon as they are available, and we sincerely appreciate the support of the investigators, and most importantly, the men and their families who participated in this important trial.”
There have been 1,022 men enrolled into SYNERGY at 148 cancer centers throughout North America, Europe, Israel and South Korea. SYNERGY completed enrollment in 2012 and final survival results are expected to be announced by mid-2014. In the investigational arm of the trial, custirsen was administered as a weekly infusion of 640 mg following three loading doses, in combination with docetaxel and prednisone given as 3-week cycles. Patients in the comparator arm received docetaxel and prednisone without custirsen. In both arms, patients were treated until disease progression, unacceptable toxicity, or completion of up to 10 cycles, unless additional cycles were deemed beneficial by the treating physician.
Custirsen received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel/prednisone. The FDA also agreed on the design of the SYNERGY trial via the Special Protocol Assessment process.
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 and has shown potential anti-tumor benefit. The most common grade 3 and grade 4 adverse events in patients on custirsen included fatigue, neutropenia, dyspnea, thrombocytopenia, anemia, febrile neutropenia and nausea. The adverse event profile and clinical benefit for custirsen will be further defined by the results from the Phase 3 clinical trials.
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 license 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 currently being evaluated in seven randomized Phase 2 trials for a variety of cancers 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: 211
