Aeterna Zentaris Inc. announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer. The trial is being sponsored by Keryx Biopharmaceuticals, Inc., (Keryx), (NASDAQ: KERX), Aeterna Zentaris' licensee for perifosine in North America. Aeterna Zentaris has also out-licensed rights for perifosine to Handok for South Korea while retaining rights for the rest of the world. The Scientific Advice from the EMA indicates that the ongoing study, in conjunction with safety data generated from other clinical studies with perifosine, is considered sufficient to provide all data necessary to support a marketing authorization of perifosine in advanced colorectal cancer. Therefore, the Company does not intend to initiate any additional study with perifosine for this indication.
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 the United States. The trial is a double-blind, placebo-controlled study of perifosine combined with bortezomib (Velcade(R)) in bortezomib pre-treated patients. Progression-free survival is the primary efficacy endpoint in this trial, which will include follow-up for overall survival.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "The EMA's positive Scientific Advice for perifosine in colorectal cancer and multiple myeloma represents a major milestone in the registration process of this compound in Europe. For the development of perifosine in both these indications, we believe that the planned North American clinical program, which is sponsored by our partner Keryx, is now sufficient for approval in Europe and in many countries in the rest of the world, where we hold rights for our compound. We are looking forward to the future development of perifosine not only in those two indications, but also in other types of cancer, which also represent significant market opportunities."