Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.
Also as I previously posted, they have a stealthyPII Trial ongoing in brain cancer with Perifosine and an mTOR inhibitor. Results due out in Dec 2016:
Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas
This study is currently recruiting participants. (see Contacts and Locations)