ATI-1123, a liposomal formulation of docetaxel - the active pharmaceutical  ingredient in TAXOTERE®, is our first product.  TAXOTERE is a well-known compound that is used around the world to treat patients with breast cancer, non-small cell lung cancer (NSCLC), hormone-refractory prostate cancer (HRPC), gastric adenocarcinoma, and squamous cell carcinoma of the head and neck. The formulation of TAXOTERE is very toxic, and is associated with numerous side effects such as hypersensitivity reactions, infections, numbness or burning in the hands and feet, hair loss, nausea and vomiting, diarrhea, and fatigue. By applying our unique process for encapsulating docetaxel in Protein Stabilizing Liposomes (PSL™)  nanoparticles, early data indicates ATI-1123 results in fewer and less severe side effects, with impressive anti-tumor activity.  Pivotal Phase II clinical studies in NSCLC, gastric cancer, pancreatic cancer, and soft-tissue sarcoma are planned.

Our second product is ATI-0918, a generic formulation of DOXIL®, a liposomal encapsulation of doxorubicin, which went off patent late 2009. DOXIL is approved for use in ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma. ATI-0918 is undergoing final laboratory studies to establish its equivalency to DOXIL, and will pursue studies in humans as required by the FDA. Due to manufacturing challenges, there is a severe world-wide shortage of DOXIL, and no generic alternative is currently on the market – AZAYA is on a path to resolve this critical problem for cancer patients.