Aeterna Zentaris, Inc. (AEZS) Obtains FDA Investigational New Drug Approval for Leading Bladder Cancer Indication

May 13, 2010 5:25 PM ETAEZS
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Aeterna Zentaris Inc. is an innovative developer of oncology and endocrine therapies like Cetrotide®, which was the very first luteinizing hormone-releasing hormone (LHRH) to obtain approval for in vitro fertilization, announced FDA approval of an Investigational New Drug (IND) application for AEZS-108 bladder cancer treatment (a conjugate compound targeting doxorubicin in LHRH-receptor-positive urothelial cells).

Phase 2 clinical trials on 64 male/female patients in advanced stages of the disease are slated for the latter half of this year, and will be conducted by Assistant Professor of Medicine, Gustavo Fernandez, M.D., at the Sylvester Comprehensive Cancer Center at the University of Miami’s Miller School of Medicine. Designed as a two-part trial, the first part will entail dose-finding measures in 12 patients, and the second will apply that dosage to generate data on progression-free survival rates.

President and CEO of AEZS, Juergen Engel, Ph.D., hailed the FDA approval and Phase 2 trial (which is a first foray in the US with AEZS-108 using male patients, and dovetails nicely with concurrent Phase 2 European trialing in advanced endometrial/ovarian cancer) as contributing to the increasingly sizeable percentage of the Company’s portfolio represented by the indication.

AEZS-108 utilizes a unique, new way to target cancer cells using a synthetic peptide carrier in conjunction with the established cytotoxic agent, doxorubicin, to enable highly selective uptake and specific binding to LHRH-receptor-positive cancer cells; the result is a focused aggregation which destroys the tumor.

Bladder cancer is the #6 cancer, showing nearly 71k new cases (14,330 fatalities) for 09 in the US alone (National Cancer Institute data), so this treatment could be a huge life-saver as well as money-maker, though the Company is still in a phase where potential investors can still get in on the ground floor before things really start moving.

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