Press releases / 9th January 2019
RadioMedix and Curium Announce FDA Fast Track Designation For 64Cu-Dotatate.
Download as PDF: English
(Houston, TX and St. Louis, MO – January 9, 2019) – RadioMedix Inc. and its commercial partner Curium announced today that their investigational diagnostic radiopharmaceutical, 64Cu-Dotatate, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). 64Cu-Dotatate is a PET diagnostic agent being studied for somatostatin receptor expressing neuroendocrine tumors (NETs). RadioMedix Inc. has completed the Phase III clinical trial of the agent and expects to file a New Drug Application with the FDA in 2019.
“If approved, 64Cu-Dotatate will be an exciting new diagnostic agent for the detection of neuroendocrine tumors,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “The FDA Fast Track designation of 64Cu-Dotatate highlights the public health need by enhancing the availability of diagnostic radiopharmaceuticals for patients with neuroendocrine tumors. 64Cu-Dotatate is anticipated to be the first neuroendocrine PET diagnostic available to all medical centers with PET capability across the country. This will address the shortage or lack of availability of somatostatin analogue PET agents that many geographies in the U.S. are experiencing.”
“Our ability to manufacture 64Cu-Dotatate at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued commitment to help patients with neuroendocrine tumors,” said Curium CEO, North America, Dan Brague. “We look forward to partnering with RadioMedix to commercialize this important diagnostic agent pending FDA approval.”
RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals. RadioMedix has also established contract service facilities for academic and industrial partners: Full cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing of the radiopharmaceuticals, and probe development and small animal Molecular Imaging Facility for pre-clinical evaluation of radiopharmaceuticals in animal models. To learn more, visit www.radiomedix.com. For more information about this press release, please contact: email@example.com
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.
With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan media contact for Curium: firstname.lastname@example.org.
About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).