- Nano cap AEterna Zentaris (AEZS +15.6%) bucks the market's bearishness. Shares are up on increased volume in response to its announcement of positive results from a 25-subject Phase 2 clinical trial assessing lead oncology compound zoptarelin doxorubicin (formerly AEZS-108) in patients with castration-resistant and taxane-resistant prostate cancer (CRPC). The data were presented at the European Cancer Congress in Vienna, Austria.
- Participants received an infusion of zoptarelin doxorubicin intravenously over two hours every three weeks. The primary endpoint was clinical benefit (CB), defined as progression-free by RECIST and PSA after treatment for at least 12 weeks.
- 20 patients have measurable disease with a median of one prior chemo regimen and median PSA value of 255.8 ng/mL (normal range is 4 ng/mL or lower). Eleven patients experienced CB and 13 achieved stable disease. Median progression-free survival (PFS) was 4.4 months and overall survival (OS) was 6 months. 44% of patients showed improvement in pain score at week 12. Maximal PSA response was stable in 20 patients.
- Side effects were substantial, however. Serious adverse events (SAEs) were grade 3-4 hematologic (n=7/25 or 28%) and grade 3 blood and lymphatic system disorders (n=5/25 or 20%). Grade 3 SAEs are considered severe and grade 4s disabling or life-threatening.
- Zoptarelin doxorubicin is a hybrid molecule comprised of a synthetic peptide (zoptarelin) carrier and a chemo agent (doxorubicin). It directs doxorubicin specifically to LHRH-receptor-expressing tumors.