Aeterna Zentaris has commenced the Phase II portion of its Phase I/II trial with AEZS-108 in castration and taxane-resistant prostate cancer (CRPC).
AEZS-108 (zoptarelin doxorubicin acetate) is the company's targeted cytotoxic luteinizing hormone-releasing hormone (LHRH) analog.
The University of Southern California Norris Comprehensive Cancer Center associate professor of medicine Dr Jacek Pinski said AEZS-108 has been very well tolerated in the heavily pre-treated population, and its efficacy has so far been impressive.
"We are fully committed to the Phase II portion of the study as shown with the opening of additional sites at the Los Angeles County Hospital, West Los Angeles and Pasadena clinics," Pinski said.
Around 37 patients with pre-treated CRPC, using the dose selected (210mg/m2) in the Phase I portion, will be involved in the single-arm Simon Optimum design Phase II study.
The Phase II portion of the study will intravenously administer AEZS-108 over two hours in repeating 21 day cycles, until progression of the disease, unacceptable toxicity or patient withdrawal.
PSA Working Group 2 guidelines will be considered as the base to calculate maximal Prostate Specific Antigen response while Response Evaluation Criteria in Solid Tumors is used to evaluate response for patients with measurable disease.
The clinical benefit of AEZS-108, defined as non-progression at 12 weeks with no dose-limiting toxicity or other toxicity requiring termination of treatment, is the primary endpoint of the Phase II portion.
Secondary endpoints include toxicity, time to RECIST and PSA progression, RECIST response rate for patients with measurable disease, PSA response rate, pain palliation and overall survival.
Aeterna Zentaris president and CEO Juergen Engel said; "AEZS-108 is a key element of our personalized medicine approach in oncology, and we look forward to results for the Phase II portion of this trial, as AEZS-108 could offer a novel targeted treatment for men suffering from prostate cancer."