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Aeterna Zentaris Reports Fourth Quarter and Full-Year 2012 Financial and Operating Results
All amounts are in U.S. dollars (unless otherwise noted) QUEBEC CITY, March 21, 2013 /C...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nAll amounts are in U.S. dollars (unless otherwise noted)\n\n\nQUEBEC CITY, March 21, 2013 /CNW Telbec/ - Aeterna Zentaris Inc.\n (NASDAQ: AEZS) (TSX: AEZ) (the \"Company\"), a late-stage drug\n development company specializing in oncology and endocrinology, today\n reported financial and operating results as at and for the fourth\n quarter and the year ended December 31, 2012.\n\n\nKey Developments in 2012\n\n\nAEZS-108 (Doxorubicin Peptide Conjugate)\n\n\n\nSpecial Protocol Assessment (\"SPA\") granted by the U.S. Food and Drug\n Administration (\"FDA\") for the initiation of a Phase 3 study in\n advanced recurrent endometrial cancer. This is an open-label,\n randomized, multicenter trial which will be conducted in North America\n and Europe, comparing AEZS-108 with doxorubicin as second-line therapy\n for locally-advanced, recurrent or metastatic endometrial cancer. The\n trial will involve approximately 500 patients and the primary efficacy\n endpoint is improvement in median overall survival.\n\n\nInitiation of the Phase 2 portion of the Phase 1/2 trial in castration-\n and taxane-resistant prostate cancer (\"CRPC\") supported by a three-year\n $1.6 million grant from the National Institutes of Health (\"NIH\") to an\n investigator to support this study. Results for the Phase 1 portion\n demonstrated that AEZS-108 was well tolerated and early evidence of\n antitumor activity was observed in men with CRPC.\n\n\n\nAEZS-130 (Oral Ghrelin Agonist)\n\n\n\nPhase 3 trial results for AEZS-130 as a diagnostic test for adult growth\n hormone deficiency (\"AGHD\") presented at the 6th International Congress of the Growth Hormone Research and Insulin-like\n Growth Factor Society in Munich, Germany. The data expanded on the\n previously disclosed data in June 2012 at the 94th ENDO Annual Meeting and Expo. Both sets of data confirm AEZS-130's\n potential of possibly becoming the first approved oral diagnostic test\n for AGHD.\n\n\nSubsequent to year-end, New Drug Application (\"NDA\") as a diagnostic\n test for AGHD remains in preparation.\n\n\n\nPerifosine (Oral AKT Inhibitor)\n\n\n\nPhase 3 trial results for perifosine + capecitabine (\"Xeloda\") showed no\n benefit in overall survival and in progression-free survival in the\n refractory colorectal cancer (\"CRC\") setting.\n\n\nSubsequent to year-end, the Company deter...