The overall goal of this project is to produce large amounts of high-quality copper-67 on a routine basis, at reasonable prices to support cancer research and approved drug products. Researchers using Cu-67 have obtained promising results. Unfortunately this isotope is sporadically available and only in limited amounts when it is available and it is very expensive. Researchers are reluctant to base their work on an isotope that may not be available in quantities to support preclinical and clinical trials and approved drug products. AlphaMed's photonuclear production technology has the potential of producing large amounts of Cu-67 at reasonable costs. Commercializing this technology will result in providing researchers with a viable source of the isotope to support their preclinical and clinical trials and approved drug products. In early studies, researchers have obtained promising results with using Cu-67 in developing therapy for a number of cancers to include non-Hodgkin's lymphoma, Hodgkin's lymphoma, acute myelogenous leukemia, and acute lymphocytic leukemia. Solid tumors such as colon cancer are also being studied. Together, the incidence of these cancers is estimated by the American Cancer Society at 180,000 per year in the US and responsible for more than 80,000 deaths. Phase I of this Fast Track SBIR will demonstrate the production of Cu-67 using the photonuclear reaction on a zinc target. Then the irradiated target will be processed for the Cu-67 which will be analyzed and used for labeling studies. During Phase II the production process will be developed and demonstrated. Large amounts of high-quality Cu-67 will be produced and analyzed in pre-clinical tests. Successful conclusion of Phase II will result in a production process suitable to support clinical trials and approved drug products.
