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AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endometrial Cancer
Date:11/24/2009

ase 2 program. Along with the recently disclosed positive results for the ovarian cancer indication, the good news for the endometrial cancer indication provides us with an even stronger basis to take the next steps in the development of AEZS-108 in gynaecological cancers."

About AEZS-108 and its Phase 2 program

AEZS-108 represents a new targeting concept in oncology using a 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 LHRH-receptor positive tumors. The binding of AEZS-108 to cancerous cells that express these receptors, results in its accumulation and preferential uptake in the malignant tissue.

In a Phase 2 study program entitled, "The antitumoral activity and safety of AEZS-108 (AN-152), a LHRH agonist linked doxorubicin in women with LHRH-receptor positive gynaecological tumors", patients with tumors expressing LHRH receptors are administered an intravenous infusion of 267 mg/m2 of AEZS-108 over a period of 2 hours, every Day 1 of a 21-day (3-week) cycle. The proposed duration of the study treatment is 6, 3-week cycles.

Study AGO-GYN 5 is performed with 14 centers of the German Gynaecological Oncology Working Group (AGO; www.ago-ovar.de), in cooperation with 3 clinical sites in Europe.

The program was planned to include up to 82 evaluable patients, up to 41 with a diagnosis of platinum-resistant and taxane-pretreated ovarian cancer, (for which positive results were disclosed on November 2, 2009) and up to 41 with advanced or recurrent endometrial cancer. For both indications, patient recruitment was planned in 2 stages, with 21 and 20 patients, respectively, and the primary efficacy endpoint at the end of stage 2 was defined as 5 or more patients with
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2. AEterna Zentaris to Present at Upcoming UBS Global Life Sciences Conference in New York
3. AEterna Zentaris Announces Outcome of Managements Strategic Review
4. AEterna Zentaris to Further Develop Three Follow-up Multi-targeted Cytotoxic Candidates to AEZS-112 as Potential Novel Cancer Treatment
5. AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers
6. AEterna Zentaris to Present at the Upcoming Roth Capital Partners 20th Annual OC Growth Stock Conference in Dana Point, California
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