METASTATIC MELANOMA

In 2006, we announced the launch of new antibody technology for the treatment of metastatic melanoma, a rare but deadly form of skin cancer.

A research team from Albert Einstein College of Medicine, led by Arturo Casadevall, M.D., Ph.D., Chairman of the Department of Microbiology & Immunology, and Ekaterina Dadachova, Ph.D., Associate Professor, Department of Nuclear Medicine, developed a novel approach to treat metastatic melanoma based on targeting melanin, a skin pigment that is released from dead melanotic tumor cells, with radio-labeled monoclonal antibodies. The antibodies seek out the released melanin and destroy human melanoma cells with a lethal dose of ionizing radiation, thus achieving a therapeutic effect. Melanin in normal, healthy tissue is not targeted because it is inside the cells and not accessible to the radio-labeled antibody.

The feasibility of this approach was tested in a proof-of-concept animal study that was published in Proceedings of the National Academy of Sciences (PNAS) in an article titled, Dead Cells in Melanoma Tumors Provide Abundant Antigen for Targeted Delivery of Ionizing Radiation by a mAb to Melanin (PNAS 2004, 101: 14865-14870). At the start of the study, mice with human melanoma cells had tumors ranging from 0.6 to 1 cm. in diameter. Tumor growth was completely inhibited in the treated group with a single dose of radio-labeled antibodies; near total tumor regression was observed in animals with smaller initial tumors. No deaths occurred among treated mice during the 30-day study. Furthermore, treated mice showed no kidney or other organ damage. In contrast, tumors continued to grow aggressively in the control group. By day 20, all the mice in the control group died except for one.

Under the terms of an agreement between Pain Therapeutics and Albert Einstein College of Medicine (AECOM), AECOM was paid an undisclosed upfront fee and may receive milestone payments totaling approximately $3.5 million in the aggregate based on clinical and regulatory progress. AECOM will also receive a 4% royalty on net sales. In exchange, Pain Therapeutics received exclusive, worldwide commercial rights to all indications in oncology and infectious disease.