Perifosine (oral Akt inhibitor)
FDA orphan-drug and Fast Track designations, as well as EMA positive Scientific Advice and orphan medicinal product designation.
- Ongoing Phase 3 trial in U.S. with additional sites in Europe and other countries
- Interim analysis expected in Q1-2013
AEZS-108 (doxorubicin peptide conjugate)
Hybrid molecule composed of a synthetic peptide carrier linked to doxorubicin, specifically targeting LHRH receptor expressing tumors.
Advanced Endometrial Cancer
- Pivotal Phase 3 trial initiated in Q1-2013 (not yet recruiting)
Advanced Ovarian Cancer
- Phase 2 trial completed
Castration- and Taxane-Resistant Prostate Cancer, Refractory Bladder Cancer and Triple Negative Breast Cancer
- Ongoing Phase 2 trials
AEZS-130 (oral ghrelin agonist)
FDA orphan-drug designation as diagnostic test for growth hormone deficiency.
Adult Growth Hormone Deficiency (AGHD)
- Phase 3 trial completed as oral diagnostic test
- NDA filing planned in Q1-2013
- Ongoing Phase 2A trial in the U.S.
Three hugely positive events scheduled in the next two months.
1. AEZS-130 - NDA filing planned in Q1-2013
2. AEZS-108 - Pivotal Phase 3 trial initiated in Q1-2013. May be a partnership announcement any day.
3. Perifosine - Interim analysis expected end of Q1-2013 or early April
Easy double from here with very little risk if one gets out before Perifosine interim analysis. Will be a 4 or 5 bagger with a AEZS 108 partnership and successful Perifosine results.