$20 million contract to develop inhaled therapy for plague, tularemia

Alachua, Florida-based Nanotherapeutics has been awarded a $20 million, four-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) to develop an inhaled version of the injectable drug, gentamicin, a broad-spectrum antibiotic which is 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. The company, using its particle formulation, has developed NanoGENT, an inhaled dry-powder formulation of gentamicin, to provide early treatment for exposure to biological warfare agents, but also for TB and other respiratory infections. Experts say that 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 beneficial for administering large-scale, immediate postexposure prophylaxis and treatment which rely on disposable multidose inhalers. The company says that an added advantage is the shelf-life stability of the product. James Talton, Ph.D., president and CEO of Nanotherapeutics, and also its cofounder, said that “The continued support from the NIAID and BARDA of Nanotherapeutics’ proprietary drug delivery systems is a terrific endorsement of our technologies and manufacturing capabilities.”

Nanotherapeutics has several partners in developing NanoGENT, among them Raleigh, North Carolina-based Respirics, Baltimore, Maryland-based Next Breath, Albuquerque, New Mexico-based Lovelace Respiratory Research Institute, and Ann Arbor, Michigan-based i3Research.

Note that Gentamicin, the leading 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. In 2005 Nanotherapeutics received funding from National Institute on Drug Abuse (NIDA) to develop an oral medication to treat opiate addiction. The company also received funding from the NIAID, as part of the NIH research program on Medical Countermeasures against Radiological and Nuclear Threats, to test the oral delivery of DTPA, an injectable treatment, and from Project Bioshield for preliminary testing of NanoGENT.