QUEBEC CITY, June 29 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today 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."
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 the United States, Canada and Mexico. Aeterna Zentaris has also out-licensed perifosine to Handok in South Korea, while retaining rights for the rest of the world.
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.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are required by a governmental authority or applicable law.
SOURCE AETERNA ZENTARIS INC.