DULLES, Va., Jan. 20, 2015 /PRNewswire/ -- IBA Molecular North America, Inc. (IBA Molecular) announced that the company is delivering unit doses of 68Ga-DOTATOC for clinical use in the NY/NJ and PA region. The first clinical site receiving doses was Icahn School of Medicine at Mount Sinai in New York, NY, which has an IND in place to study the clinical use of 68Ga-DOTATOC. IBA Molecular is supplying the drug for the research study.
68Ga-DOTATOC is currently designated as an orphan drug by the FDA for management of neuroendocrine tumors (NET). There are approximately 110,000 new cases of NET diagnosed in the U.S. each year. According to the Society of Nuclear Medicine and Molecular Imaging, a range of studies are being pursued on its safety and efficacy, with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC.
“We are pleased to be working with IBA Molecular for the supply of this important new tracer,” said Lale Kostakoglu, MD, MPH, Chief of Nuclear Medicine and Molecular Imaging at Icahn School of Medicine at Mount Sinai. “The ability of IBA Molecular to provide CGMP-manufactured unit doses of this compound is key to the success of this new phase of our molecular imaging program.”
“Our commitment to the future of nuclear medicine and molecular imaging is highlighted by the range of novel radiopharmaceuticals we are currently supplying to clinical research studies worldwide,” noted Lee Karras, President of IBA Molecular NA. “We are pleased to be partnering with major research institutions like Mount Sinai to assist in these endeavors.”
Mr. Karras added, “IBA Molecular has used its extensive know-how in the areas of CGMP radiopharmaceutical development and manufacturing, including the use of sophisticated analytical methods and techniques, to ensure that these products fulfill strict FDA requirements.”
About 68Ga-DOTATOC
[68Ga]-DOTA-tyr3-Octreotide ([68Ga]-DOTATOC) is based on 68Gallium, a positron emitting generator-produced isotope, with a half-life of 68 minutes. The parent nuclide of 68Ga is 68Ge, which has a half-life of 270.8 days. 68Ga decays through positron emission and electron capture. 68Ga DOTATOC has not been approved by the FDA nor has its safety and effectiveness been established in clinical studies. The product is being studied under physician-sponsored IND by major cancer centers in the U.S. and abroad.
IBA Molecular North America, Inc.
IBA Molecular North America, Inc. is part of IBA Molecular, a global developer, manufacturer and distributor of radiopharmaceutical products and supporting services used in molecular imaging. IBA Molecular has engineered a strong and unique product portfolio and pipeline of diagnostic and therapeutic tracers aimed at advancing the development of the global movement towards personalized medicine and making molecular imaging/therapy a major discipline in healthcare. The company also provides educational, technical and marketing support to medical specialists worldwide to help better respond to patient needs. Founded in 1986, IBA Molecular, with North American headquarters in Dulles, Virginia, is jointly owned by SK Capital Partners and Ion Beam Applications S.A. The company is a leading manufacturer and distributor of PET agents in North America, and PET and SPECT agents in Europe and Asia, with a network of 49 sites worldwide.
For more information, please visit www.ibamolecular.com
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SOURCE IBA Molecular North America, Inc.
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