Aeterna Zentaris Inc., an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs, announced that a first patient has been treated for the randomized phase II trial in chemotherapy refractory triple-negative (ER/PR/HER2-negative) luteinizing hormone-releasing hormone receptor (LHRH-R)-positive metastatic breast cancer, with the Company's targeted doxorubicin peptide conjugate, AEZS 108.

Alberto J Montero, MD, assistant professor, Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Centre at the University of Miami Miller School of Medicine, is the lead investigator of this trial which also include sites at the Universities of Regensburg and Goettingen, in Germany.

Juergen Engel, PhD., president and CEO of Aeterna Zentaris stated, "Patients with triple negative breast cancer have poorer outcomes compared to other breast cancer subtypes and are in need of a safe and effective therapeutic regimen. Because LHRH receptors are expressed in a majority of triple-negative breast cancers, we believe AEZS-108 could represent a novel targeted treatment for these patients. Expansion into the breast cancer indication with AEZS-108 after positive phase II results in endometrial and ovarian cancer, as well as positive interim phase I/II results in prostate cancer, is further proof of the potential of this innovative compound in a variety of cancer indications for both women and men."

This is an open-label, randomized, two-arm, multi-centre phase II study which will involve up to 74 patients. Patients will be randomized in a 1:1 ratio into one of the two treatment arms: AEZS 108 (267 mg/m2 every 21 days) [Arm A] or SSC (standard single agent cytotoxic chemotherapy [Arm B]) at the discretion of the treating oncologist.

The primary study endpoint is median time of progression-free survival. Secondary endpoints include overall response-rate, and overall survival. The study will also evaluate AEZS-108's toxicity profile and patients' quality of life relative to conventional cytotoxic chemotherapy.

According to the American Cancer Society, breast cancer is the most prevalent form of cancer in women after skin cancers. In 2012, an estimated 226,870 new cases of invasive breast cancer were diagnosed in women in the US, and about 39,510 of them were expected to die from this disease.

About 10 per cent to 20 per cent of breast cancers are triple-negative breast cancer (TNBC), a subtype of breast cancer that is clinically negative for expression of estrogen and progesterone receptors (ER/PR) and human epidermal growth factor receptor-2 (HER2). It is characterized by its unique molecular profile, aggressive behaviour, distinct patterns of metastasis, and lack of targeted therapies. Chemotherapy has been the mainstay of treatment for women with TNBC, but this current standard-of-care is suboptimal. Despite best available therapy, TNBC continues to be associated with poorer outcomes when compared with other breast cancer subtypes.

AEZS-108 represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. AEZS-108 is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to Luteinizing Hormone-Releasing Hormone (LHRH)-receptor expressing tumors, resulting in more targeted treatment with less damage to healthy tissue. The product has successfully completed phase II studies for the treatment of ovarian and endometrial cancer and the Company is currently planning a phase III trial in endometrial cancer under a Special Protocol Assessment. AEZS-108 is also in phase II trials in prostate, breast and bladder cancer. AEZS-108 has been granted orphan drug designation by the FDA and orphan medicinal product designation from the European Medicines Agency for the treatment of ovarian cancer. Aeterna Zentaris owns the worldwide rights to AEZS-108.