Aeterna Zentaris Says Phase 3 Clinical Study of Zoptrex Failed to Meet Primary Endpoint.
M2 PHARMA-May 2, 2017-Aeterna Zentaris Says Phase 3 Clinical Study of Zoptrex Failed to Meet Primary Endpoint
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- US-based biopharmaceutical company Aeterna Zentaris Inc.'s (NASDAQ: AEZS) (TSX: AEZS) 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, the company said.
The ZoptEC pivotal Phase 3 trial was a fully-recruited (512 patients), open-label, randomised-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 randomised 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. Secondary EPs include progression-free survival, objective response-rate, and clinical benefit rate.
The trial was conducted under a Special Protocol Assessment with the US Food and Drug Administration.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health.
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|Article Type:||Clinical report|
|Date:||May 2, 2017|
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