Inhaled Cidofovir Dry-Powder Formulation for Postexposure Prophylaxis and Treatment of Smallpox

Nanotherapeutics and its subcontractors have been tasked with developing a dry-powder inhaled formulation of cidofovir, branded as NanoFOVIR, intended for the treatment and postexposure prophylaxis of smallpox. Their responsibilities include formulating the drug for inhalation, conducting in vivo studies to evaluate efficacy at various doses and schedules, and performing preclinical safety and acute toxicology assessments in animal models. Additionally, they will scale up manufacturing for a lead inhaled dosage form and prepare the necessary documentation to submit an Investigational New Drug (IND) application to the FDA, facilitating the initiation of a phase I clinical safety trial. The contract commenced on August 15, 2009, and will continue through August 14, 2014, operating under a Cost Plus Fixed Fee arrangement. The work is to be performed in Alachua, Florida, with oversight and communication facilitated by designated contract officials. The project focuses on advancing a novel therapeutic approach targeting smallpox through inhaled cidofovir, aiming to enhance drug delivery and safety profiles compared to current treatment options.