Company Expects to Submit Macrilen™ NDA in Third Quarter of 2017
CHARLESTON, SC, USA I May 1, 2017 I Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the “Company”) today announced that the ZoptEC Phase 3 clinical study of Zoptrex™ (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex™ as compared to patients treated with doxorubicin.
Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “The median overall survival period for patients treated with Zoptrex™ was 10.9 months compared to 10.8 months for patients treated with doxorubicin. This is not a statistically significant, clinically meaningful increase in overall survival and thus the ZoptEC Phase 3 clinical study did not meet its primary endpoint. In addition, Zoptrex™ generally performed no better than the comparator drug with respect to the secondary efficacy endpoints. For example, the median period of progression-free survival of the patients in the Zoptrex™ arm of the study was identical to that for patients in the doxorubicin arm. Finally, there was no meaningful difference between the two arms with respect to safety; the number of patients with cardiac disorders was similar – eight in the Zoptrex™ arm and nine in the doxorubicin arm. Therefore, the results of the study are not supportive to pursue regulatory approval.”
David A. Dodd, the President and Chief Executive Officer of the Company, stated, “We are very disappointed with the outcome of the ZoptEC Phase 3 clinical study. Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex™ with respect to any other indications. I would like to thank my colleagues within Aeterna Zentaris and our external team of clinical investigators for their dedication to and contributions on this project.” Commenting on the Company’s plans, Mr. Dodd continued, “Our focus has now shifted entirely to filing our new drug application for Macrilen™ and, if the product is approved, to its commercial launch as soon as possible. We will also optimize our resources to be consistent with our focus on Macrilen™-related efforts. We continue to believe in the potential that Macrilen™ provides for us to become a focused specialty pharmaceutical company. Our intention is to submit the Macrilen™ NDA in the third quarter of 2017 and, if the product receives FDA approval, to commercially launch the product in the first quarter of 2018.”
Conference Call
The Company will host a conference call to discuss the results of the ZoptEC Phase 3 clinical study of Zoptrex ™ on Monday, May 1, 2017, at 8:30 AM, Eastern Time. Participants may access the conference call by using the following number: 201-689-8029, Confirmation 13660857.
About the ZoptEC Pivotal Phase 3 Trial
The ZoptEC pivotal Phase 3 trial was a fully-recruited (512 patients), 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. Patients were centrally randomized in a 1:1 ratio and received either Zoptrex™ (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every three weeks and for up to nine cycles. Response was evaluated every three cycles during treatment, and thereafter, every 12 weeks until progression. All patients were followed for survival as the primary efficacy endpoint (“EP”). Secondary EPs include progression-free survival, objective response-rate, and clinical benefit rate. The trial was conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (“FDA”). For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We recently completed Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in non-U.S. territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
SOURCE: Aeterna Zentaris
Post Views: 401
Company Expects to Submit Macrilen™ NDA in Third Quarter of 2017
CHARLESTON, SC, USA I May 1, 2017 I Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the “Company”) today announced that the ZoptEC Phase 3 clinical study of Zoptrex™ (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex™ as compared to patients treated with doxorubicin.
Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “The median overall survival period for patients treated with Zoptrex™ was 10.9 months compared to 10.8 months for patients treated with doxorubicin. This is not a statistically significant, clinically meaningful increase in overall survival and thus the ZoptEC Phase 3 clinical study did not meet its primary endpoint. In addition, Zoptrex™ generally performed no better than the comparator drug with respect to the secondary efficacy endpoints. For example, the median period of progression-free survival of the patients in the Zoptrex™ arm of the study was identical to that for patients in the doxorubicin arm. Finally, there was no meaningful difference between the two arms with respect to safety; the number of patients with cardiac disorders was similar – eight in the Zoptrex™ arm and nine in the doxorubicin arm. Therefore, the results of the study are not supportive to pursue regulatory approval.”
David A. Dodd, the President and Chief Executive Officer of the Company, stated, “We are very disappointed with the outcome of the ZoptEC Phase 3 clinical study. Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex™ with respect to any other indications. I would like to thank my colleagues within Aeterna Zentaris and our external team of clinical investigators for their dedication to and contributions on this project.” Commenting on the Company’s plans, Mr. Dodd continued, “Our focus has now shifted entirely to filing our new drug application for Macrilen™ and, if the product is approved, to its commercial launch as soon as possible. We will also optimize our resources to be consistent with our focus on Macrilen™-related efforts. We continue to believe in the potential that Macrilen™ provides for us to become a focused specialty pharmaceutical company. Our intention is to submit the Macrilen™ NDA in the third quarter of 2017 and, if the product receives FDA approval, to commercially launch the product in the first quarter of 2018.”
Conference Call
The Company will host a conference call to discuss the results of the ZoptEC Phase 3 clinical study of Zoptrex ™ on Monday, May 1, 2017, at 8:30 AM, Eastern Time. Participants may access the conference call by using the following number: 201-689-8029, Confirmation 13660857.
About the ZoptEC Pivotal Phase 3 Trial
The ZoptEC pivotal Phase 3 trial was a fully-recruited (512 patients), 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. Patients were centrally randomized in a 1:1 ratio and received either Zoptrex™ (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every three weeks and for up to nine cycles. Response was evaluated every three cycles during treatment, and thereafter, every 12 weeks until progression. All patients were followed for survival as the primary efficacy endpoint (“EP”). Secondary EPs include progression-free survival, objective response-rate, and clinical benefit rate. The trial was conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (“FDA”). For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We recently completed Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in non-U.S. territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
SOURCE: Aeterna Zentaris
Post Views: 401
