According to a company media release, Aeterna Zentaris has initiated the Phase II component of the Phase I/II trial of AEZS 108 in the treatment of men with castration- and taxane-resistant prostate cancer.
The full text of the media release is available on line as are the preliminary data from the Phase I component of the trial, which were initially presented in February 2012 at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. The eligibility criteria and other information for those interested in participating in the Phase II component of this trial can be found on the ClinicalTrials.gov web site.
As we have noted previously, AEZS 108 is a hybrid molecule that combines a synthetic peptide carrier and a well-known and widely used chemotherapeutic agent (doxorubicin). AEZS 108 is the first intravenous drug to go into clinical trials that is designed to target a chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in more specific treatment to prostate cacner cells and less damage to healthy tissue.
What will need to be demonstrated during this Phase II trial are some clear signals that AEZS 108 actually has significant clinical activity that might be expected to suggest a long-term survival benefit in men with metastatic, castration-resistant prostate cacner (mCRPC) who have already progressed after first-line chemotherapy with a docetaxel-based chemotherapy regimen.