Influenza is characterized by recurrent annual epidemics and periodic major worldwide pandemics. Because of the high disease-related morbidity and mortality, direct and indirect socio-economic impacts of influenza are enormous. In the last 100 years, there have been 3 major influenza pandemics. It has been about thirty years since the last pandemic. A new pandemic is considered imminent and one of the biggest challenges facing public health systems today. With recent technical progress, it has also become possible for bio-terrorists to create potential pandemic viral strains faster than natural evolution of the viruses. Therefore, a broad-spectrum therapeutic/prophylactic product for influenza is critically needed. We have identified a drug lead, Fludase(tm), which targets on all strains and subtypes of influenza including the potential pandemic strains. With the funding from a Phase I Biodefense SBIR application, we have demonstrated its efficacy against a variety of influenza viruses. Unlike the currently available Flu vaccines, Fludase(tm) does not need to be updated yearly. Fludase(tm) can be produced cost effectively and can be readily available at the onset of a natural pandemic or bio-warfare, and for annual epidemics. As a protein-based therapeutic agent administered topically and locally, Fludase(tm) can also potentially avoid the side effects and the risk of generating drug resistant viruses associated with the currently available expensive antiviral compounds. The objective of this grant application is to complete all necessary pre-clinical development and to initiate early stage clinical development of Fludase(tm).

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AI056786-04
Application #
7105473
Study Section
Special Emphasis Panel (ZRG1-IDM-B (12))
Program Officer
Krafft, Amy
Project Start
2005-08-15
Project End
2008-07-31
Budget Start
2006-08-01
Budget End
2007-07-31
Support Year
4
Fiscal Year
2006
Total Cost
$2,000,000
Indirect Cost
Name
Nexbio, Inc.
Department
Type
DUNS #
140600268
City
San Diego
State
CA
Country
United States
Zip Code
92121
Triana-Baltzer, Gallen B; Sanders, Rebecca L; Hedlund, Maria et al. (2011) Phenotypic and genotypic characterization of influenza virus mutants selected with the sialidase fusion protein DAS181. J Antimicrob Chemother 66:15-28
Triana-Baltzer, Gallen B; Babizki, Maria; Chan, Michael C W et al. (2010) DAS181, a sialidase fusion protein, protects human airway epithelium against influenza virus infection: an in vitro pharmacodynamic analysis. J Antimicrob Chemother 65:275-84
Triana-Baltzer, Gallen B; Gubareva, Larisa V; Nicholls, John M et al. (2009) Novel pandemic influenza A(H1N1) viruses are potently inhibited by DAS181, a sialidase fusion protein. PLoS One 4:e7788