Aeterna Zentaris: Encouraging Final Data for Phase 1 Portion of Ongoing Phase 1/2 Trial with Zoptarelin Doxorubicin (AEZS-108) in Prostate Cancer Reported at ASCO

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[{"type":"text","content":"\n\n\nQUÉBEC CITY, June 3, 2013 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that final data for\n the Phase 1 portion of the ongoing Phase 1/2 trial with its lead\n oncology compound, zoptarelin doxorubicin (AEZS-108), demonstrated the\n compound's promising anti-tumor activity in heavily pre-treated men\n with castration- and taxane-resistant prostate cancer. Results were\n presented earlier today by lead investigator, Jacek Pinski, MD, PhD, of\n the USC Norris Comprehensive Cancer Center, during a poster session at\n the American Society of Clinical Oncology's (\"ASCO\") Annual Meeting in\n San Francisco.\n\n\nDavid Dodd, President and CEO of Aeterna Zentaris stated, \"We are\n encouraged with the Phase 1 portion data and look forward to further\n results from the current Phase 2 portion of this investigator-driven\n trial. Because luteinizing hormone-releasing hormone receptors are\n expressed in a great number of prostate cancers, we believe that\n zoptarelin doxorubicin (AEZS-108), which specifically targets those\n receptors, may represent a novel targeted treatment for men with this\n disease. Expansion into prostate, breast and bladder cancer with\n zoptarelin doxorubicin (AEZS-108) after positive Phase 2 results in\n endometrial and ovarian cancer, is further demonstration of the\n potential of this innovative compound in a variety of cancer\n indications for both men and women.\"\n\n\nMethods\n\n\nThis was a dose-escalation Phase 1 trial in men with castration- and\n taxane-resistant prostate cancer to confirm the dose established in a\n Phase 1 trial in women. Patients received zoptarelin doxorubicin\n (AEZS-108) every 21 days until progression or unacceptable toxicity.\n The primary endpoint was safety. Circulating Tumor Cells (\"CTC\") were\n captured with a novel slot microfilter and identified by PSA and DAPI\n staining. AEZS-108 internalization was visualized by fluorescence\n microscopy.\n\n\nResults\n\n\nEighteen men with a median of 2 prior chemotherapy regimens (range 1-5)\n and a median PSA of 106.4 ng/mL (range 8.4-1624.0) were enrolled. The\n dose of zoptarelin doxorubicin (AEZS-108) was escalated from 160 mg/m2 to 210 mg/m2 then to 267 mg/m2. There were 2 Dose-Limiting Toxicities (\"DLT\") in the 7 patients\n receiving zoptare...

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