Published on September 30, 2009 at 7:41 AM
Æterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today reported that the 043 Thorough QT (TQT) trial, which is part of the cetrorelix pamoate clinical development program in benign prostatic hyperplasia (BPH), met its primary endpoint. Results showed that cetrorelix did not increase heart rate-corrected QT interval (QTc) at either time of observed maximal concentration of cetrorelix (CetroMax) or at the time of minimum level of serum testosterone (TestMin). Current guidance through the International Conference on Harmonization (ICH) E14 recommends that all new chemical entities undergo a TQT trial to assess their potential to induce QT interval changes. Therefore, this trial was conducted in accordance with ICH guidance. As announced on March 6, 2009, sanofi-aventis U.S. LLC, entered into an agreement with Æterna Zentaris for the development, registration and marketing of cetrorelix in BPH for the U.S. market.
Source: AETERNA ZENTARIS INC.