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FDA Awards Research Grants Totaling More than $19 Million

September 25, 2015

The FDA has awarded research grants totaling more than $19 million to boost the development of products to treat 17 different rare diseases, many of which have little or no available treatment options.

Seventeen grants were awarded through the Orphan Products Grants Program for drugs or biologics. The grant recipients include:

  • Albert Einstein College of Medicine (Bronx), $1.6 million over four years for a Phase 2 study of intravenous gammaglobulin for treating sickle cell acute pain;
  • Baylor College of Medicine (Houston), $1.2 million over three years for a Phase 2 study of ADXS11-001, a vaccine for the treatment of HPV-related oropharyngeal cancer;
  • Beckman Research Institute of the City of Hope (Duarte, Calif.), $600,000 over three years for a Phase 1 study of cellular immunotherapy for the treatment of malignant glioma;
  • Columbia University (New York City), $600,000 over three years for a Phase 1A/B study of 11-1F4 mAb for the treatment of al amyloidosis;
  • Edimer Pharmaceuticals (Cambridge, Mass.), $1.6 million over four years for the Phase 2 study of EDI200 for the treatment of x-linked hypohidrotic ectodermal dysplasia;
  • Emory University (Atlanta, Ga.), $1.6 million over four years for a Phase 2 study of l-arginine therapy for the treatment of pediatric sickle cell disease pain;
  • IUPUI (Indianapolis, Ind.), $1.6 million over four years for a Phase 2 study of imatinib for the treatment of airway tumors in children with neurofibromatosis and $600,000 over three years for the treatment of autosomal dominant polycystic kidney disease;
  • NYU School of Medicine (New York City), $1.1 million over three years for a Phase 2 study of carbidopa for the treatment of familial dysautonomia;
  • Northshore University Healthsystem (Evanston, Ill.), $220,000 over three years for a Phase 1 study of naltrexone for the treatment of mesenteric panniculitis;
  • Rhythm Metabolic (Boston), $1 million over three years for a Phase 2 study of a melanocortin 4 receptor agonist for the treatment of Prader Willi Syndrome;
  • Scioderm (Durham, N.C.), $400,000 for one year for a Phase 2 study of SD-101 for the treatment of epidermolysis bullosa;
  • Sloan-Kettering Institute Cancer Research (New York City), $900,000 over four years for a Phase 3 Study of sorafenib for the treatment of desmoid tumors or aggressive fibromatosis;
  • Transderm (Santa Cruz, Calif.), $400,000 over two years for a Phase 1 study of sirolimus for the treatment of pachyonychia congenital;
  • University of California San Diego (La Jolla, Calif.), $1.6 million over four years for a Phase 2 study of a vascular-targeted prodrug for the treatment of recurrent glioblastoma;
  • University of Kansas Medical Center (Kansas City, Kan.), $1.6 million over four years for a Phase 2 study of arimoclomol for the treatment of sporadic inclusion body myositis; and
  • University of Michigan (Ann Arbor, Mich.), $1.6 million over four years for a Phase 3 study of standard vs reduced IV fat for the prevention of parenteral nutrition-associated cholestasis. — Kellen Owings