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Phase 1/2 Clinical Trial Results of Perifosine Plus Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Published in the Journal of Clinical Oncology
QUEBEC CITY, Oct. 13, 2011 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nQUEBEC CITY, Oct. 13, 2011 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that a manuscript\n entitled \"Perifosine Plus Bortezomib and Dexamethasone in patients with\n Relapsed/Refractory Multiple Myeloma Previously Treated with\n Bortezomib: Results of a Multicenter Phase 1/2 Trial\" reporting Phase 1/2 combination activity of perifosine in the\n treatment of advanced multiple myeloma (MM) patients, was selected for\n publication in the October 10, 2011 online edition of the Journal of\n Clinical Oncology (JCO). Perifosine, is the Company's novel,\n potentially first-in-class, oral anti-cancer drug that inhibits Akt\n activation in the phosphoinositide 3-kinase (PI3K) pathway, which is\n currently being investigated in metastatic colorectal cancer, as well\n as other cancer indications.\n\n\nThe ongoing Phase 3 study in MM is being conducted under a Special\n Protocol Assessment (SPA), and Fast Track designation, as agreed with\n the Food & Drug Administration (FDA). Perifosine is currently also in\n Phase 3 clinical development for refractory advanced colorectal cancer,\n also under an SPA and Fast Track designation. Perifosine has been granted Orphan Drug Status by FDA and orphan\n medicinal product designation from the European Medicines Agency (EMA)\n in MM, and has received positive Scientific Advice from the EMA for\n both the MM and advanced colorectal cancer programs, with the ongoing\n Phase 3 trials for these indications expected to be sufficient for\n registration in Europe.\n\n\nIn this Phase 1/2 study, perifosine in combination with bortezomib +/-\n dexamethasone was evaluated in 84 heavily pre-treated patients with\n relapsed or relapsed/refractory MM. All patients were required to\n receive prior bortezomib and most were bortezomib refractory (73%). The\n combination demonstrated an overall response rate (ORR) including MR or\n > of 41% in all evaluable patients, with stable disease observed in an\n additional 41% of evaluable patients. The ORR was 65% for\n bortezomib-relapsed patients and 32% for patients with\n bortezomib-refractory disease. Median progression-free survival (PFS)\n was 6.4 months, with a median PFS of 8.8 months in the\n bortezomib-relapsed population. Median overall survival (OS).Therapy\n was generally well-tol...