Year | Company | Award type | Disease | Isotope | Target or targeted agent | Aims |
2009 | Immunomedics, Inc. | Phases I and II | Non-Hodgkin lymphoma | 90Y | Epratuzumab | Reevaluate maximum tolerated dose for fractionated weekly injection of 90Y-epratuzumab (previously found to be 2 × 0.74 GBq/m2) in standard phase I setting; proceed into phase II trial to evaluate response and safety |
2009 | Acaduceus Pharmaceutics, Inc. | Phase I | Prostate cancer | 90Y | BBN-RGD | Synthesize 90Y-BBN-RGD peptide radiotracers and characterize their hydrophilicity, receptor binding affinity, and cytotoxicity in vitro; determine pharmacokinetics/pharmacodynamics, radiation dosimetry, and maximum tolerable dose of 90Y-BBN-RGD in mice |
2009 | SibTech, Inc. | Phases I and II | Breast cancer | 177Lu | VEGF | Phase II: Establish dose and time dependence for scVEGF/Lu-induced destruction of tumor vasculature and potential roles of overexpressed endogenous VEGF; establish optimal sequence for scVEGF/Lu-doxorubicin combination as adjuvant therapy for recurrent breast cancer |
2009 | Molecular Insight Pharmaceuticals, Inc. | Phases I and II | Metastatic melanoma | 131I | Ioflubenzamide | Phase II: Complete clinical imaging study on 12 subjects with confirmed metastatic malignant melanoma to determine safety and organ dosimetry; select therapeutic starting dose for therapy escalation study |
2009 | Molecular Insight Pharmaceuticals, Inc. | Phases I and II | Metastatic melanoma | 131I | MIP-1145 | Phase II: Develop continuous flow production process and good-manufacturing-practice production; perform animal safety and toxicity testing |
2010 | Molecular Insight Pharmaceuticals, Inc. | Phase I | Prostate cancer | 131I | PSMA | Obtain preclinical data on 131I-labeled MIP-1072 and establish its potential to target PSMA-expressing tumors; determine in vitro prostate cancer cells binding characteristics; preform organ distribution and treatment efficacy studies in rodent tumor models |
2010 | IsoTherapeutics Group, LLC | Phases I and II | Bone metastases | 153Sm | DOTMP | Phase II: Manufacture clinical-grade CycloSam; verify that clinical-grade CycloSam has same biodistribution as obtained in phase I, using rats and dogs; perform dose escalation studies treating canine bone tumors to determine maximum dose that can be given without clinically significant suppression of bone marrow |
2010 | Solixia, Inc. | Phase I | Ovarian cancer | 188Re | Folate receptor | Prepare 188Re-labeled hot-dot conjugates with folic acid and test performance of these conjugates in cell-binding assays to determine optimal formulations; assess radiation dosimetry of most promising conjugate in relevant animal model |
BBN = bobesin; RGD = cyclic arginine-glycine-aspartic acid; VEGF = vascular endothelial growth factor; PSMA = prostate-specific membrane antigen; GC = glucosamine conjugate.
All information in this table is publicly accessible at http://projectreporter.nih.gov/reporter.cfm.