Nanotherapeutics, Inc., has announced that it has been awarded a $20 Million 4-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 that 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.
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.
James D. Talton, Ph.D., President and C.E.O. of Nanotherapeutics and co-founder of the company said, “We are very pleased to receive this contract to fund this product development program. The continued support from the NIAID and BARDA of Nanotherapeutics’ proprietary drug delivery systems is a terrific endorsement of our technologies and manufacturing capabilities. The continued development of NanoGENT™ with our partners Respirics, Next Breath, Lovelace Respiratory Research Institute, and i3Research is a strategically important milestone for the company as it demonstrates the utility of our technology to meet a significant medical need. We are confident we will be able to develop a novel improved formulation that can rapidly and effectively provide therapeutic results into a viable product.”
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.
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™. Nanotherapeutics has one approved injectable product and several products in advanced development, manufactured in-house under cGMP. 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"
15th October 2007