For more information on this trial, consult clinicaltrials.gov under NCT01698281.
About Breast Cancer and Triple-Negative Breast Cancer
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 U.S., and about 39,510 of them were expected to die from this disease.
About 10% to 20% 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 behavior, 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.
About AEZS-108 (doxorubicin peptide conjugate)
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 2 studies for the treatment of ovarian and endometrial cancer and the Company is currently planning a Phase 3 trial in endometrial cancer under a Special Protocol Assessment. AEZS-108 is also in Phase 2 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.