Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that perifosine, its oral AKT inhibitor, combined with temsirolimus ("TEM"), was well tolerated in an investigator driven Phase 1 clinical trial in recurrent or progressive malignant glioma ("MG"). Data were presented over the weekend by Thomas J. Kaley, MD, Director, Neuro-Oncology Fellowship Program at Memorial Sloan-Kettering Cancer Center, during a poster session at the Society of Neuro-Oncology annual meeting in Washington D.C.
The trial involved 32 patients with recurrent or progressive (glioblastoma (16), anaplastic astrocytoma (7), anaplastic oligodendroglioma (7), and transformed low-grade gliomas (2)), with median Karnofsky Performance Status ("KPS") 80 (range, 60-100). Twenty-one patients were refractory to bevacizumab or other anti-VEGF/VEGFR therapy. The dose of TEM was escalated in each cohort using standard 3 + 3 design from 15 mg to 170 mg administered once weekly. The dose of perifosine was a 600 mg loading dose on day 1, followed by a 100 mg nightly dose, for dose level 1 through dose level 6. At dose level 7, the loading dose was increased to 900 mg, followed by a 100 mg nightly dose.