RadioMedix, Inc. Receives FDA Orphan Drug Designation for the 68Ga-DOTATATE (GalioMedixTM) for the Management of the Neuroendocrine Tumors

RadioMedix, Inc. is proud to announce that the company has received approval of “Orphan Drug Designation” for 68Ga-DOTATATE (GalioMedix ™) as a diagnostic agent for the management of patients with neuroendocrine tumors (NETs) by U.S Food and Drug Administration (FDA).

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Houston, TX (PRWEB) January 05, 2014

RadioMedix, Inc. is proud to announce that the company has received approval of “Orphan Drug Designation” for 68Ga-DOTATATE (GalioMedix ™) as a diagnostic agent for the management of patients with neuroendocrine tumors (NETs) by U.S Food and Drug Administration (FDA). “This approval will significantly expedite and facilitate the commercialization process and access of the NET patients to the 68Ga PET/CT technology. Preliminary results on GalioMedix™ are highly promising and have shown superior sensitivity, and image resolution compared to other currently available modalities. Also, the test is completed in 2 hours and provides quantification capability that is not available by Octreoscan ® which is the currently approved agent,” said Dr. Delpassand, Chairman and CEO of RadioMedix. The Orphan drug status is granted to drugs for the effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. NETs qualify this definition.“This is a significant achievement of our clinical and scientific teams at RadioMedix and our sister institution, Excel Diagnostics and Nuclear Oncology Center. The Orphan Drug Designation awarded for 68Ga-DOTATATE (GalioMedix™) radiotracer will significantly help in expedited and less expensive regulatory pathway for the final approval of the drug by FDA . The successful collaboration between the Excel Diagnostics and Nuclear Oncology Center and RadioMedix will have a positive impact on expansion of 68Ga radiotracers beyond management of NETs,” continued Dr. Delpassand.

“We are very excited that recent expansion of RadioMedix’s cGMP facilities can provide support in the 68Ga-DOTATATE dose preparation and investigational kit formulation”- said Dr. Izabela Tworowska, RadioMedix’s Chief Scientific Officer.

RadioMedix Inc.
RadioMedix, Inc. is a Clinical Phase biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring and therapy of cancer. The company is commercializing generator-produced radiopharmaceuticals based on Gallium-68 chemistry. RadioMedix has also established service facilities for academic and industrial partners: cGMP Manufacturing Suite for clinical probe development and Molecular Imaging Facility for evaluation of agents in animal models. Our company serves as collaborators on several on-going clinical trials and provides service in chemistry and radiochemistry and clinical dose formulation.


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