Production of Commerical High Specific Activity Sn-117M Radiochemical and Chelates

As outlined in the document, Technical Topics Descriptions, FY 2012, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs, July 2011, page 137: Sn-117m has gotten a lot of interest in the last few years. It has favorable nuclear properties for both imaging and therapy. However commercial quantities of the isotope at high specific activity are not available. Supply of commercial quantities of high specific activity Sn-117m would be of high interest. Sn-117m has traditionally been made in significant quantities in reactors, but the low specific activity ( & lt;10 Ci/g) produced by this method inherently restricts its applications. The difficulty of producing high specific activity Sn-117m has been a barrier to entry for this isotope into the field of nuclear medicine. In recent years, accelerator produced material has been demonstrated with high specific activities ( & gt;1000 Ci/g); but, producing and purifying commercial quantities at a reasonable cost remains a challenge. We plan to provide a reliable commercial source of accelerator-based, high specific activity Sn-117m radiochemical for new medical products anticipated to enter the medical markets over the next few years. This will make it possible to prepare a variety of Sn-117m labeled compounds ranging from small chelates to large proteins such as monoclonal antibodies that target cancer. Our Phase I work demonstrated the principle that very pure, high specific activity Sn-117m and chelates can be produced to have potential medical applications. This work now needs to be extended in Phase II to demonstrate commercial feasibility by increasing the quantity and range of Sn-117m based products. In order to achieve this, we propose a Phase II SBIR that expands on our successful Phase I project to include the following specific aims: (i) To adequately supply high specific activity Sn-117m to R & amp;D activities over next 2-3 years we will reproducibly prepare the Sn-117m in high enough quantities to perform chelation and conjugation experiments that could be used in human clinical studies; (ii) To develop Sn-117m labeled chelates/molecular versions of pharmaceuticals that are/will be in clinical use and would benefit from substituting Sn-117m; and (iii) To define the pathway to a future large-scale commercial production facility, we will show it is possible to scale up the production of Sn-117m to commercially relevant quantities, prepare a market study for the anticipated demand in Clear Vasculars products (radiochemical and pharmaceuticals) and detail a clear pathway to realization. Commercial Applications and Other Benefits: Clear Vascular, Inc. and other companies and research groups are presently developing Sn-117m based radiopharmaceuticals for imaging and therapy for a number of medical conditions. The Clear Vascular product is an injectable radioactive imaging agent that targets vulnerable plaque and can be imaged non-invasively using any standard gamma camera found in any cardiology practice. Other groups using Sn-117m (and/or its chelates) include: Serene Oncology (cancer), Rheumco (rheumatoid and osteoarthritis), University of Arizona (medical and engineering programs), the Belgian University of Louvain (somatostatin analogues), and inviCRO (SPECT imaging).