Tuesday, December 01, 2015 9:08:11 AM
"if we decide to go forward in prostate cancer or any other cancer suitable for Armune’s compelling technology platform.”
Thought they were going ahead in prostate cancer?
Listed in pipeline:
Results - Phase 2 portion of completed Phase 1/2 study in prostate cancer:
This was a single-arm Simon Optimum design Phase 2 study of zoptarelin doxorubicin in 25 patients with CRPC. Patients received zoptarelin doxorubicin (210 mg/m2) intravenously over 2 hours, every 3 weeks. The primary endpoint was CB, defined as remaining progression-free by RECIST and PSA after treatment for 12+ weeks. Secondary endpoints were progression free survival (PFS), best overall response, toxicity, pain and overall survival (OS).
Results
Twenty patients had measurable disease, with a median of 1 prior chemotherapy regimens and a median PSA of 255.8 ng/ml. Eleven patients experienced CB; 13 patients achieved stable disease. Median PFS and OS were 4.4 months (95% CI: 3.6, 5.5) and 6 months (95% CI: 4.2, 10.7) respectively. Forty-four percent of patients demonstrated improvement of pain score at 12 weeks. Maximal PSA response was stable in 20 patients. Zoptarelin doxorubicin demonstrated good tolerability with grade 3-4 hematologic (n=7) and grade 3 blood and lymphatic system disorders (n=5) adverse events as the most common events.
Results were presented by lead investigator Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center, during a poster session at the 18th ECCO – 40th ESMO European Cancer Congress in Vienna, Austria, on September 28, 2015.
Titled, “A Phase 2 Trial of AEZS-108 in Castration- and Taxane-Resistant Prostate Cancer”, Liu SV, Tsao-Wei DD, Xiong S, Groshen S, Dorff TB, Quinn DI, Tai YC, Engel J, Hawes D, Schally AV, Pinski J, the poster is available at this link.
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