ErgoMed’s Co-Development Partner AEterna Zentaris Completes Patient Recruitment For Zoptec Phase 3 Study With Zoptarelin Doxorubicin In Advanced Endometrial Cancer
Guildford, UK – 30 June 2015: Ergomed plc, (LSE: ERGO or ‘Ergomed’) a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, is pleased to note that its co-development partner Aeterna Zentaris (NASDAQ: AEZS) (TSX: AEZ), has completed the recruitment of 500 patients for its Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) pivotal study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer.
Miroslav Reljanovic, Chief Executive Officer of Ergomed, commented: “The ZoptEC study is being conducted in over 120 sites in North America, Europe and Israel, and we are pleased that recruitment goals were met ahead of schedule, This is testament to Ergomed’s international experience and local knowledge, which enables the most efficient study management structure through our site management model, delivering faster recruitment of quality patients to agreed timelines.
“We believe that zoptarelin doxorubicin has the potential to provide a new treatment for women with endometrial cancer, and look forward to obtaining data and progressing this study with our co-development partner Aeterna Zentaris, who are also advancing their plans for the commercialisation of this product.”
The announcement issued by Aeterna Zentaris follows:
Aeterna Zentaris Completes Patient Recruitment for ZoptEC Phase 3 Study with Zoptarelin Doxorubicin in Advanced Endometrial Cancer
Québec City, Canada, June 30, 2015 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer. The trial is being conducted in over 120 sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in overall survival.
Following its first pre specified interim analysis last April, a Data and Safety Monitoring Board recommended that the ZoptEC Phase 3 study continue as planned. A second interim analysis is expected during Q4, 2015 at approximately 192 events, with the final analysis planned at an anticipated 384 events. The trial is expected to be completed by the end of 2016.
David Dodd, Chairman and CEO of Aeterna Zentaris, commented: “We are very excited to have completed patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer earlier than expected, and I would like to thank everyone involved in this project for their steadfast commitment. We believe zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, could represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that we do not intend to pursue ourselves. Furthermore, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to provide therapies to patients and their physicians that can potentially improve and extend the quality of lives.”
About the ZoptEC Phase 3 trial
The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (“FDA”). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint (“EP”). Secondary EPs include progression free survival, objective response-rate, and clinical benefit rate.
For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).
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Miroslav Reljanovic, Chief Executive Officer of Ergomed, commented: “The ZoptEC study is being conducted in over 120 sites in North America, Europe and Israel, and we are pleased that recruitment goals were met ahead of schedule, This is testament to Ergomed’s international experience and local knowledge, which enables the most efficient study management structure through our site management model, delivering faster recruitment of quality patients to agreed timelines.
“We believe that zoptarelin doxorubicin has the potential to provide a new treatment for women with endometrial cancer, and look forward to obtaining data and progressing this study with our co-development partner Aeterna Zentaris, who are also advancing their plans for the commercialisation of this product.”
The announcement issued by Aeterna Zentaris follows:
Aeterna Zentaris Completes Patient Recruitment for ZoptEC Phase 3 Study with Zoptarelin Doxorubicin in Advanced Endometrial Cancer
Québec City, Canada, June 30, 2015 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer. The trial is being conducted in over 120 sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in overall survival.
Following its first pre specified interim analysis last April, a Data and Safety Monitoring Board recommended that the ZoptEC Phase 3 study continue as planned. A second interim analysis is expected during Q4, 2015 at approximately 192 events, with the final analysis planned at an anticipated 384 events. The trial is expected to be completed by the end of 2016.
David Dodd, Chairman and CEO of Aeterna Zentaris, commented: “We are very excited to have completed patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer earlier than expected, and I would like to thank everyone involved in this project for their steadfast commitment. We believe zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, could represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that we do not intend to pursue ourselves. Furthermore, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to provide therapies to patients and their physicians that can potentially improve and extend the quality of lives.”
About the ZoptEC Phase 3 trial
The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (“FDA”). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint (“EP”). Secondary EPs include progression free survival, objective response-rate, and clinical benefit rate.
For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).
Help employers find you! Check out all the jobs and post your resume.