http://biz.yahoo.com/prnews/050808/lam050.html?.v=19
NexBio Receives a $6 Million NIH SBIR Grant for the Clinical
Development of a Novel Influenza Medicine
Monday August 8, 8:30 am ET
SAN DIEGO, Aug. 8 /PRNewswire/ -- NexBio, Inc. announced today that the
National Institute of Allergy and Infectious Diseases (NIAID), a
component of the National Institutes of Health (NIH), has awarded the
company a $6 million Phase II SBIR Grant to further test the company's
lead drug candidate, Fludase® (DAS181)*, for the prevention and
treatment of influenza. NexBio recently completed a pre-IND
(Investigational New Drug Application) meeting with the U.S. Food and
Drug Administration (FDA) and will submit an IND to FDA and initiate
human trials on Fludase® shortly thereafter.
Fludase® represents a First-In-Class approach to fight influenza. The
drug candidate works by preventing all types and strains of influenza
virus from entering the airway epithelial cells, including avian
influenza as well as parainfluenza viruses. It aims at providing
broad-spectrum protection, improved clinical efficacy, reduced
likelihood of drug resistance, and a cost effective medicine for
influenza. Fludase® will not require annual updates as with influenza
vaccines, and therefore, it can be stockpiled for both annual influenza
epidemics and emergency use for future influenza pandemics.
"The US government's strong support has been vital to NexBio's research
and development programs on influenza," says Fang Fang, M.D., Ph.D.,
NexBio's Chief Scientific/Medical Officer. "The mounting threat of an
imminent influenza pandemic, the unreliable vaccine supplies for recent
influenza epidemics, and increasing viral resistance to the limited
selection of antiviral drugs have all added urgency to our cause.
NexBio will continue to work closely with the NIH, CDC, and the FDA to
expedite Fludase® development. We are also actively seeking corporate
partnerships from companies that have extensive experience in late
stage drug development and commercialization," added Dr. Fang.
Influenza is a highly infectious respiratory disease that has plagued
the human race since ancient times. It is characterized by recurrent
annual epidemics and periodic major worldwide pandemics. Every year,
influenza remains the most common cause of medically attended acute
respiratory illness. An influenza pandemic with an H5N1 strain is
considered imminent, and is one of the biggest challenges facing public
health systems worldwide. The shortage of influenza vaccine in recent
years, along with the unavailability of a vaccine for the H5N1
influenza virus, and the emergence of strains resistant to current
antiviral compounds, have caused increasingly serious concerns
regarding this imminent influenza pandemic. While pursuing a fast-track
approval process, NexBio also plans to pursue the possibility of the
emergency use of Fludase® and stockpiling in preparation for the
influenza pandemic.
ABOUT NEXBIO
NexBio, Inc. is a privately held development-stage biopharmaceutical
company located in San Diego. NexBio's mission is to develop novel,
broad-spectrum prophylaxis and therapeutics for the prevention and
treatment of life-threatening human respiratory infectious diseases in
order to save lives and to improve the quality of life.
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taxpayers footing bill for corporation, is this really needed?
TC