NanoDTPA™ Oral Chelator

Diethylenetriamine pentacetic acid (DTPA) is a chelator that forms stable complexes with certain metals in the body and produces more rapid elimination. DTPA has been shown effective in depleting certain radionucleotides from the body and has been approved for intravenous (IV) administration by the FDA for that purpose. In the event of a mass exposure, such as a nuclear spill or a "dirty bomb" (an explosive device that spreads radioactive material across an area using conventional or non-nuclear explosives), internal contamination may occur through inhalation or dermal exposure (through open wounds or shrapnel). DTPA is approved for the treatment of radioactive contamination of Americium-241, Californium-252, Cerium-141, 144, Curium-244, and Plutonium-239, 238. IV administration makes it impracticable to treat a large number of exposed people in the event of a terrorist attack with a dirty bomb. Changes in how DTPA is made (formulated) could improve the drug's absorption and lead to it being taken less often, or in smaller amounts, or promote improved patient compliance. The NanoDTPA™ program has been established to develop a new formulation of DTPA that can be easily administered by oral means.

NanoDTPA™ is a novel, oral swallowed capsule formulation of DTPA that is being developed for the treatment of radionucleotide exposure. The specific formulation and capsule size has been optimized for use during an event such as a nuclear spill or population exposure to radiation after a "dirty bomb" event. There is also potential for use of this product for iron chelation for the treatment of iron overload. Iron overload often results from repeated blood transfusions for the treatment of Beta-thalassemia, Myelodysplastic syndromes, and Sickle Cell Disease.

Nanotherapeutics has contracted with the National Institute of Allergy and Infectious Diseases (NIAID) to develop NanoDTPA™. Preclinical studies of this oral capsule formulation have demonstrated good pharmacokinetic and safety profiles in rodent and dog models. It is anticipated that a pre-IND package will be submitted to the FDA by the end of 2009, ultimately seeking FDA drug approval via Section 505(b)(2) and a submission under the 'Animal Rule'.

This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (DHHS), under Contract No. HHSN266200500046P.