AEterna Zentaris Receives Positive Scientific Advice from the European Medicines Agency for its Phase 3 Program with Perifosine in Multiple Myeloma
Company Has Also Requested Scientific Advice on its Phase 3 Program with Perifosine in Refractory Advanced Colorectal Cancer.
In multiple myeloma, the SPA-agreed upon Phase 3 study is a double-blind, placebo-controlled study of perifosine combined with bortezomib (Velcade(R)) in bortezomib pretreated patients. Progression-free survival will be the primary efficacy endpoint in this trial, which will include follow-up for overall survival. The advice from the EMA indicates that, in principle, the proposed study is considered sufficient to provide all data necessary to support a marketing authorization of perifosine in combination with bortezomib (Velcade(R)). At the relevant time, the actual approved indication in
AEterna Zentaris has also requested Scientific Advice for the development of perifosine in refractory advanced colorectal cancer, where the SPA-agreed upon Phase 3 study 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 will be intensively pretreated and will have failed all available treatment options except capecitabine (Xeloda(R)). Overall survival will be analyzed as the primary efficacy endpoint. For both indications, safety data from studies of perifosine in other indications and drug combinations will be used as supportive information to define the clinical safety profile of perifosine.
About Scientific Advice
Scientific Advice is a procedure offered by the European Medicines Agency 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 is a novel, potentially first-in-class, oral anticancer agent that modulates Akt, and a number of other key signal transduction pathways, including the JNK and MAPK pathways, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. The effects of perifosine on Akt are of particular interest because of the importance of this pathway in the development of most cancers, with evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy, and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis.
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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