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NexBio Completes First-in-Man Clinical Trial With DAS181 (Fludase(R)) and Strengthens Clinical Leadership
Date:1/19/2009

SAN DIEGO, Jan. 19 /PRNewswire/ -- NexBio announces the completion of its First-In-Man clinical trial of DAS181 (Fludase(R)), an investigational drug candidate for influenza. The single-dose, escalating Phase I study completed in December 2008 was designed to assess DAS181 safety in healthy subjects. The study drug was well tolerated at all dose levels. DAS181 is a novel broad-spectrum drug candidate for prophylaxis and treatment of respiratory infections by all variations of influenza virus, including the types of the virus that may cause a potential influenza pandemic. In addition, DAS181 also has the potential for prophylaxis and treatment of influenza-like illness due to other respiratory viruses, including the parainfluenza virus which may cause serious respiratory illness similar to influenza for which there is no approved vaccine or therapeutic. The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

DAS181, a recombinant fusion protein, inactivates viral receptors on the cells of the human respiratory tract, thereby preventing influenza and parainfluenza viruses from infecting the human body or from amplifying in infected individuals. DAS181 effectively inhibits numerous strains of influenza and parainfluenza virus in cell culture and in animal models. Unlike current antiviral compounds and vaccines, DAS181 targets human host receptors, not virus components, and thus carries a reduced risk of drug resistance compared with the currently available antiviral drugs. Extensive, prolonged nonclinical studies have not shown the development of any meaningful resistance.

To strengthen DAS181 clinical development, NexBio announces the hiring of Ronald B. Moss, M.D., as NexBio's Executive Vice President of Clinical Development & Medical Affairs. Dr. Moss brings 22 years of research and clinical experience, including 15 years of pharmaceutical drug development experience ranging from phase 1 to NDA, and extensive expertise in clinical, regulatory and quality affairs. He previously worked at several biopharmaceutical companies in various capacities including Rhone Poulenc Rorer (now Aventis), Immune Response Corporation and Merck. Most recently, he was Vice President of Clinical Development at Vical, Inc, a publicly-traded company, where he guided the clinical development of various biological products for emerging infectious diseases, including U.S. Government-funded development of a pre-pandemic influenza vaccine. Dr. Moss earned his M.D. from Chicago Medical School and completed his residency in Pediatrics, followed by a fellowship at NIAID.

"I look forward to the opportunity to execute the critical tasks that are required for the successful clinical development of DAS181 at NexBio. DAS181 represents a vital new approach to preventing and treating pandemic influenza." said Dr. Moss. "As a practicing physician, I also appreciate the urgent medical need for a new, broad-spectrum agent to address seasonal influenza-like illness, one that combines the best features of vaccines and current antiviral compounds. My clinical development experience will help to ensure that DAS181 development is done in a safe, careful, and timely manner."

To further broaden the clinical expertise to support DAS181 development, NexBio has recently formed a Clinical Advisory Board chaired by Andrew T. Pavia, MD FIDSA, FAAP. Dr. Pavia is the George and Esther Gross Presidential Professor and Chief of the Division of Pediatric Infectious Diseases at the University of Utah Health Sciences Center. He has been very involved in infectious disease research and policy. Dr. Pavia has served on several advisory committees for the federal government, and led several committees of the Infectious Diseases Society of America, including the Institute of Medicine Committee on "Antivirals for Pandemic Influenza: Guidance on Developing and Distribution and Dispensing System." Dr. Pavia's research interests include the epidemiology of influenza and other emerging infections; he has published more than 100 scientific articles and chapters. He also has significant experience in the clinical development of antiviral compounds.

"There is a tremendous need for new antivirals for both seasonal and pandemic influenza" said Dr. Pavia. "The successful record of antiviral drug development for HIV has shown us the tremendous potential of drugs to treat fast mutating viruses, but also the challenge of having a clinical development program that adapts to the clinical need."

Influenza is a highly infectious acute respiratory disease that has plagued the human race since ancient times. It is characterized by recurrent annual epidemics and periodic major worldwide pandemics. Annual epidemics cause approximately 300,000 hospitalizations and 36,000 deaths in the United States alone. In the 20th century, at least three influenza pandemics have occurred (1918, 1957, and 1968). Together, they caused millions of deaths. Since 2003, the avian influenza H5N1 has spread to hundreds of poultry farms in Asia, Europe, and Africa. Based on the latest data from the World Health Organization, 391 people have been infected by the virus in 15 countries resulting in 247 deaths.

ABOUT NEXBIO

NexBio, Inc. is a privately held development-stage biopharmaceutical company located in San Diego. NexBio's mission is to save lives and to improve the quality of life by creating and commercializing novel, broad-spectrum biopharmaceuticals to prevent and treat current and emerging life-threatening diseases. Viradin(TM), invented by NexBio, is a parenteral protein under development, currently at lead optimization stage, directed to the treatment of viral hemorrhagic fever caused by viruses such as Ebola and Marburg, as well as the treatment of sepsis and septic shock. TOSAP(TM) is a microparticle formulation technology invented and developed by NexBio and used to formulate DAS181 for inhalation, as well as the compounds of partners, under license. NexBio has recently begun a TOSAP(TM) collaboration with a Pharma company to formulate one of their proprietary antibodies.

For more information about NexBio, Inc., please visit http://www.nexbio.com

    Contact:

    David Wurtman, M.D., M.B.A.
    VP, Corporate Development
    10665 Sorrento Valley Road
    San Diego, CA  92121
    Phone: (858) 452-2631
    dwurtman@nexbio.com

Note: FDA has yet to approve the name Fludase.

DISCLOSURE NOTICE:

This release contains forward-looking information about the research and development program of NexBio and the potential efficacy of product candidates that might result from programs that involve substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development activities; decisions by regulatory authorities regarding whether and when to permit the clinical investigation of or approve any drug applications that may result from the programs as well as their decisions regarding labeling and other matters that could affect the commercial potential of product candidates that may result from the program; and competitive developments.


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SOURCE NexBio, Inc.
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