Final Phase 1 data of zoptarelin doxorubicin Phase 1/2 trial published in Clinical Cancer Research

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company")  announced that an article on final data for the Phase 1 portion of the ongoing Phase 1/2 trial in prostate cancer with zoptarelin doxorubicin (formerly AEZS-108), a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin, has been published in the December issue of Clinical Cancer Research. The article outlines data previously disclosed in June 2013 at the American Society of Clinical Oncology's ("ASCO") Annual Meeting, which demonstrated the compound's safety profile and promising anti-tumor activity in heavily pre‑treated men with castration- and taxane-resistant prostate cancer. These results led to the current investigator-driven Phase 2 portion in this same indication under the supervision of lead investigator, Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center. Titled, "Phase I, Dose-Escalation Study of the Targeted Cytotoxic LHRH Analog AEZS-108 in Patients with Castration- and Taxane-Resistant Prostate Cancer", Liu SV, Tsao-Wei DD, Xiong S, Groshen S, Dorff TB, Quinn DI, Tai YC, Engel J, Hawes D, Schally AV, Pinski J., the article is available at this link: Clin Cancer Res.

Final Phase 1 data of zoptarelin doxorubicin Phase 1/2 trial published in Clinical Cancer Research

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer

Aeterna Zentaris Inc. announced that it has reached an agreement with FDA  on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission. 

About AEZA-108 : AEZS-108: AEZS-108 (AN-152, or zoptarelin doxorubicin) is a targeted cytotoxic peptide conjugate which is a hybrid molecule composed of a synthetic peptide carrier and a well-known cytotoxic agent, doxorubicin. The design of this product allows for the specific binding and selective uptake of the cytotoxic conjugate by the LHRH receptor-positive tumors. The binding of conjugate molecule AEZS-108 to cancerous cells that express these receptors results in its accumulation in the malignant tissue. This binding is followed by internalization and retention of the cytotoxic drug, doxorubicin, in the cells. Therefore, since they target specific cells, cytotoxic conjugates are postulated to be more effective and have less side-effects than the respective non-conjugated/non-linked cytotoxic agents in inhibiting tumor growth. AEZS-108 is the first drug in a clinical study that targets the cytotoxic activity of doxorubicin specifically to LHRH-receptor expressing tumors. 

"We are pleased with the agreement with the FDA which provides us with a clearly defined development and regulatory pathway for AEZS-108 in endometrial cancer", stated Juergen Engel , PhD, President and CEO at Aeterna Zentaris. "AEZS-108's innovative targeted approach could offer a new treatment option for women with endometrial cancer and provide the Company with a significant market opportunity."

Aeterna Zentaris reaches SPA agreement with FDA for AEZS-108 Phase 3 trial in endometrial cancer