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FDA awards 15 grants for clinical trials to stimulate product development for rare diseases

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579366.htm

A total of 76 grant applications were received for this fiscal year, with a funding rate of 20 percent. The grant recipients for fiscal year 2017 are the following:

AADi, LLC (Pacific Palisades, California), Neil Desai, Phase 2 Study of ABI-009 for the Treatment of Advanced Perivascular Epithelioid Cell Tumors — about $2 million over four years

Albert Einstein College of Medicine (Bronx, New York), Caterina Minniti, Phase 2 Study of Topical Sodium Nitrite for the Treatment of patients with Sickle Cell Disease & Leg Ulcers — about $2 million over four years

Albert Einstein College of Medicine (Bronx, New York), Eric Hollander, Phase 2 Study of Oxytocin for the Treatment of Hyperphagia in Prader-Willi Syndrome — about $1.5 million over three years

Alkeus Pharmaceuticals, Inc. (Cambridge, Massachusetts), Leonide Saad, Phase 2 Study of ALK-001 for the Treatment of Stargardt Disease – about $250,000 over one year

CereNova, LLC (Durham, North Carolina), Daniel Laskowitz, Phase 2A Study of CN-105 for the Treatment of Intracerebral Hemorrhage — about $1 million over two years

Columbia University Medical Center (New York), Elizabeth Shane, Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women — about $1.9 million over four years

Columbia University Medical Center (New York), Gulam Manji, Phase 2 Study of PLX3397 + Sirolimus for the Treatment of Malignant Peripheral Nerve Sheath Tumors — $2 million over four years

Dana-Farber Cancer Institute (Boston), Steven Dubois, Phase 1 Study of dual PI3K/BRD4 Inhibitor SF1126 for the Treatment of Neuroblastoma — $750,000 over three years

Duke University (Durham, North Carolina), Allan Kirk, Phase 2 Study of Belatacept, Alemtuzumab, and Sirolimus in Renal Transplantation — about $1 million over three years

Johns Hopkins University (Baltimore), Susan Dorman, Phase 2a Study of Rifampin, Merrem and Augmentin for the Treatment of Pulmonary Tuberculosis — about $2 million over four years

New York Medical College (Valhalla, New York), Mitchell Cairo, Phase 2 Defibrotide for the Prevention of Complications in High-Risk Sickle Cell Disease Patients Following Allogeneic Stem Cell Transplantation – about $1.75 million over four years

Protalex, Inc (Florham Park, New Jersey), Richard Francovitch, Phase 1/2 Study of PRTX-100 for the Treatment of Immune Thrombocytopenia — about $500,000 over two years

Sloan-Kettering Institute for Cancer Research (New York), Ping Chi, Phase 2 Study of MEK162 & Imatinib for the Treatment of Gastrointestinal Stromal Tumors — $2 million over four years

Tocagen Inc. (San Diego), Asha Das, Phase 2/3 Study of Toca 511 +Toca FC versus SOC in Recurrent Glioblastoma and Anaplastic Astrocytoma — $2 million over four years

University of California, San Francisco (San Francisco), Marshall Stoller, Phase 2 Study of Lipoic Acid for the Treatment of Cystine Nephrolithiasis — about $2 million over four years