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Aeterna Zentaris Presented Poster on Oral Prostate Cancer Vaccine, AEZS-120, at International Urology Conference in Japan
Filing of Clinical Trial Application (CTA) in Prostate Cancer Expected in Q4 2012 QUE...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nFiling of Clinical Trial Application (CTA) in Prostate Cancer Expected\n in Q4 2012\n\n\nQUEBEC CITY, Oct. 2, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that preclinical data\n on its oral prostate cancer vaccine candidate, AEZS-120, were presented\n over the weekend at the 32nd Congress of the Société Internationale d'Urologie, which is being held in Fukuoka, Japan. The presentation underlined the\n feasibility of an oral therapeutic vaccination approach against\n prostate cancer. Furthermore, safety pharmacology and toxicology data\n suggest that the profile of AEZS-120 is similar to the approved carrier\n strain and, therefore, pave the way for Phase 1 clinical testing.\n\n\nJuergen Engel, PhD, President and CEO at Aeterna Zentaris, commented,\n \"Now that we have completed the preclinical development program for\n AEZS-120, we look forward to filing a Clinical Trial Application in\n Europe during this quarter, in order to initiate a Phase 1 clinical\n trial in prostate cancer with this novel oral anticancer vaccine.\"\n\n\nSummary and Conclusions\n\n\nThe production, release, pharmacology, safety and toxicology program was\n conducted in agreement with the regulatory authorities and successfully\n finalized:\n\n\nThe proof of concept has been shown in a tumor-challenge mouse model\n using the anticipated clinical application schedule;\n\n\nBiosafety and biodistribution studies did not reveal a different safety\n profile compared to the carrier strain;\n\n\nPharmacological and toxicological studies did not reveal differences to\n the approved carrier strain;\n\n\nIn all, the non-clinical studies suggest that the safety and\n toxicological profile of AEZ-120 is similar to the approved carrier\n strain S. typhi Ty21a, which has already been safely applied in more\n than 250 million doses;\n\n\nGMP material for clinical use has been produced and released; and CTA\n filing for Phase 1 clinical study is planned in 4Q 2012.\n\n\nThe poster titled, \"Preclinical Proof of Concept and Characterization of AEZS-120, a\n Therapeutic Oral Prostate Cancer Vaccine Candidate Based on Live\n Recombinant Attenuated Salmonella\", J. Fensterle, B. Bergmann, P. Schmidt, M. Teifel, J. Engel, T. Rudel,\n W. Goebel, and U. Rapp, can be viewed by clicking on the f...