QUEBEC CITY, Nov. 14 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc.(Nasdaq: AEZS TSX: AEZ;), a global biopharmaceutical company focused onendocrine therapy and oncology, today announced the completion of patientrecruitment for the Company's European multi-center Phase 2 trial in non-smallcell lung cancer (NSCLC) with its novel, first-in-class, oral signaltransduction inhibitor, perifosine. This randomized, double-blind,placebo-controlled trial will assess the efficacy and safety of a 150 mg dailydose of perifosine when combined with radiotherapy in 160 patients withinoperable Stage III NSCLC.
David J. Mazzo, Ph.D., President and Chief Executive Officer at AeternaZentaris said, "We are pleased to have completed enrollment for our Phase 2trial with perifosine in combination with radiotherapy. Patients will befollowed for a one-year period after receiving treatment, and therefore, weexpect to announce top-line results at the end of 2008."
About the Phase 2 Trial
Patients receive perifosine daily for 5 to 6 weeks, starting seven daysprior to radiotherapy, and are followed for at least 12 months. The primaryendpoint of this trial is the extent and duration of local control, i.e., theabsence of tumor recurrence or progression in the area that has beenirradiated.
The trial is being conducted in collaboration with the Netherlands CancerInstitute. The lead investigator is Marcel Verheij, MD, Ph.D., of theDepartment of Radiation Oncology / Division of Cellular Biochemistry, at TheNetherlands Cancer Institute in Amsterdam.
Perifosine is a novel, first-in-class, oral anti-cancer agent thatmodulates several key signal transduction pathways, including Akt, MAPK, andJNK that have been shown to be critical for the survival of cancer cells.Perifosine has demonstrated single agent anti-tumor activity in Phase 1 andPhase 2 studies and is currently being studied as a single agent and incombination with several forms of anti-cancer treatments for various forms ofcancer. Perifosine is licensed to Keryx Biopharmaceuticals in the UnitedStates, Canada and Mexico.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a global biopharmaceutical company focused onendocrine therapy and oncology with proven expertise in drug discovery,development and commercialization.
News releases and additional information are available atwww.aeternazentaris.com.
This press release contains forward-looking statements made pursuant tothe safe harbor provisions of the U.S. Securities Litigation Reform Act of1995. Forward-looking statements involve known and unknown risks anduncertainties, which could cause the Company's actual results to differmaterially from those in the forward-looking statements. Such risks anduncertainties include, among others, the availability of funds and resourcesto pursue R&D projects, the successful and timely completion of clinicalstudies, the ability of the Company to take advantage of businessopportunities in the pharmaceutical industry, uncertainties related to theregulatory process and general changes in economic conditions. Investorsshould consult the Company's quarterly and annual filings with the Canadianand U.S. securities commissions for additional information on risks anduncertainties relating to the forward-looking statements. Investors arecautioned not to rely on these forward-looking statements. The Company doesnot undertake to update these forward-looking statements. We disclaim anyobligation to update any such factors or to publicly announce the result ofany revisions to any of the forward-looking statements contained herein toreflect future results, events or developments except if we are requested by agovernmental authority or applicable law.
SOURCE AETERNA ZENTARIS INC.