Aeterna Zentaris Receives Positive Scientific Advice from the European Medicines Agency for its Phase 3 Trial with Perifosine in Colorectal Cancer
The multicenter X-PECT (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) Phase 3 study involving approximately 430 patients, is a double-blind, placebo-controlled study comparing the combination of perifosine and capecitabine (Xeloda(R)) with single-agent capecitabine (Xeloda(R)). Patients in this study have been intensively pre-treated and have failed all available treatment options except capecitabine (Xeloda(R)). Overall survival will be analyzed as the primary efficacy endpoint, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety.
Last April, Aeterna Zentaris had also received positive Scientific Advice from the EMA for the ongoing Phase 3 trial in multiple myeloma with perifosine, being conducted by Keryx in
About Scientific Advice
Scientific Advice is a procedure offered by the EMA to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice is limited to scientific issues, i.e. to quality, non-clinical and clinical aspects of the concerned medicinal product not yet unequivocally covered by published scientific guidelines. Scientific Advice focuses on development strategies rather than pre-evaluation of data to support a Marketing Authorization Application. Scientific Advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes.
Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials for advanced colorectal cancer and multiple myeloma, under Special Protocol Assessment and Fast Track designation granted by the Food and Drug Administration (FDA) for both indications. FDA has also granted perifosine orphan-drug status for multiple myeloma. In addition to its positive Scientific Advice for perifosine in colorectal cancer, the EMA had previously issued positive Scientific Advice, as well as positive opinion for Orphan Medicinal Product designation for perifosine in multiple myeloma. Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.
Perifosine is licensed to Keryx in
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.
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