TABLE 3

NCI SBIR–Funded TRT Grants from 2009 to 2010

YearCompanyAward typeDiseaseIsotopeTarget or targeted agentAims
2009Immunomedics, Inc.Phases I and IINon-Hodgkin lymphoma90YEpratuzumabReevaluate 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
2009Acaduceus Pharmaceutics, Inc.Phase IProstate cancer90YBBN-RGDSynthesize 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
2009SibTech, Inc.Phases I and IIBreast cancer177LuVEGFPhase 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
2009Molecular Insight Pharmaceuticals, Inc.Phases I and IIMetastatic melanoma131IIoflubenzamidePhase 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
2009Molecular Insight Pharmaceuticals, Inc.Phases I and IIMetastatic melanoma131IMIP-1145Phase II: Develop continuous flow production process and good-manufacturing-practice production; perform animal safety and toxicity testing
2010Molecular Insight Pharmaceuticals, Inc.Phase IProstate cancer131IPSMAObtain 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
2010IsoTherapeutics Group, LLCPhases I and IIBone metastases153SmDOTMPPhase 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
2010Solixia, Inc.Phase IOvarian cancer188ReFolate receptorPrepare 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.