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Aeterna Zentaris' Zoptarelin Doxorubicin Meets Phase 2 Primary Endpoint in Prostate Cancer.


- Canadian pharmaceutical company Aeterna Zentaris Inc.'s (NASDAQ: AEZS) (TSX: AEZ) lead oncology compound, zoptarelin doxorubicin (formerly AEZS108), has met the primary end-point of the investigator-driven and sponsored Phase 2 clinical trial in Castration and taxane Resistant Prostate Cancer and demonstrated good tolerability, the company said.

The primary endpoint was Clinical Benefit defined as remaining progression-free by RECIST and Prostate Specific Antigen after treatment for 12+ weeks.

This was a single-arm Simon Optimum design Phase 2 study of zoptarelin doxorubicin in 25 patients with CRPC. Patients received zoptarelin doxorubicin (210 mg/m2) intravenously over two hours, every three weeks.

The primary endpoint was CB, defined as remaining progression-free by RECIST and PSA after treatment for 12+ weeks. Secondary endpoints were progression free survival, best overall response, toxicity, pain and overall survival.

Twenty patients had measurable disease, with a median of 1 prior chemotherapy regimens and a median PSA of 255.8 ng/ml.

Eleven patients experienced CB; 13 patients achieved stable disease. Forty-four percent of patients demonstrated improvement of pain score at 12 weeks.

Maximal PSA response was stable in 20 patients. Zoptarelin doxorubicin demonstrated good tolerability with grade 34 hematologic and grade three blood and lymphatic system disorders adverse events as the most common events.

Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin.

According to the company, Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue.

The company is currently conducting a fully-enrolled ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer; results from a second interim analysis of this trial are expected in October 2015.

Zoptarelin doxorubicin is also in an investigatorinitiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong andMacau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune's Global 500 list.

On April 16, 2015, the company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique, significantly lower cost in the manufacturing process.

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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Publication:M & A Navigator
Date:Sep 30, 2015
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