Aeterna Zentaris: Data Demonstrate that Perifosine Combined with Temsirolimus Was Well Tolerated in Phase 1 Trial in Malignant Glioma

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[{"type":"text","content":"\n\n\n\n\n\nQUÉBEC CITY, Nov. 19, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that perifosine, its\n oral AKT inhibitor, combined with temsirolimus (\"TEM\"), was well\n tolerated in an investigator driven Phase 1 clinical trial in recurrent\n or progressive malignant glioma (\"MG\"). Data were presented over the\n weekend by Thomas J. Kaley, MD, Director, Neuro-Oncology Fellowship\n Program at Memorial Sloan-Kettering Cancer Center, during a poster\n session at the Society of Neuro-Oncology annual meeting in Washington\n D.C.\n\n\nThe Study\n\n\nThe trial involved 32 patients with recurrent or progressive\n (glioblastoma (16), anaplastic astrocytoma (7), anaplastic\n oligodendroglioma (7), and transformed low-grade gliomas (2)), with\n median Karnofsky Performance Status (\"KPS\") 80 (range, 60-100).\n Twenty-one patients were refractory to bevacizumab or other\n anti-VEGF/VEGFR therapy. The dose of TEM was escalated in each cohort\n using standard 3 + 3 design from 15 mg to 170 mg administered once\n weekly. The dose of perifosine was a 600 mg loading dose on day 1,\n followed by a 100 mg nightly dose, for dose level 1 through dose level\n 6. At dose level 7, the loading dose was increased to 900 mg, followed\n by a 100 mg nightly dose.\n\n\nResults\n\n\nThe trial is currently accruing to dose level 5 (115 mg) after 2\n dose-limiting toxicities (\"DLT\") in the dose level 7 (170 mg) and dose\n level 6 (170 mg) expansion cohorts. Maximum tolerated dose (\"MTD\") was\n not defined. Thirty-one patients were evaluable for toxicity. There\n were 5 DLTs: thrombocytopenia (3), intra-cerebral hemorrhage (1), and\n lung infection (1). Only one grade 4 toxicity (thrombocytopenia) was\n reported. Most frequent grade 3 non dose-limiting hematologic\n toxicities were lymphopenia (7), hyperglycemia (4), lung infection (4),\n and hypophosphatemia (3). Notable grade 2 toxicities were\n hypophosphatemia (14), hypocholesterolemia (13), and\n hypertriglyceridemia (11).\n\n\nPreliminary survival results demonstrated that median overall survival\n was 7.4 months. There were 27 radiographic responses: complete response\n (0), partial response (2), stable disease (13) and progressive disease\n (12).\n\n\nConclusion\n\n\nCombination therapy with TEM ≥ 115 mg w...

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