NanoGENT™ Inhaled Gentamicin Dry-Powder Formulation

Nanotherapeutics is developing an inhaled version of the injectable drug, gentamicin, a broad-spectrum antibiotic, to be used as a first-line therapy for pneumonic plague and tularemia, Category A bioterrorism agents. Both diseases are highly infectious and could pose a serious danger if used as an aerosolized biological weapon. Using its novel particle formulation, the company has developed NanoGENT™, an inhaled dry-powder formulation of gentamicin, to provide early treatment for exposure to biological warfare agents, as well as TB and other respiratory infections. In the event of an accidental or deliberate exposure to these agents, noninvasive drug delivery systems, such as improved inhaled and nasal delivery would be especially beneficial for administering wide-spread immediate post-exposure prophylaxis and treatment using disposable multi-dose inhalers with adequate shelf-life stability.

Gentamicin, the front-line therapy for plague and tularemia, is a generic drug approved by the FDA for injection. For many years it has been used in a saline nebulized version to treat Pseudomonas respiratory infections, particularly in patients with cystic fibrosis. Nanotherapeutics and its collaborators will continue the clinical development of NanoGENT™ and expect to bring it to human clinical trials to evaluate the safety and pharmacokinetics in the fourth year of its NIAID/BARDA contract. 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. HHSN27220070030C.