SAN DIEGO, May 3 NexBio, Inc. announced today the initiation of a trial of DAS181 (Fludase®) in patients with the respiratory conditions asthma and bronchiectasis, being conducted by researchers with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This trial will examine the effects of DAS181 in subjects with well-controlled or stable pulmonary disease. Patients with pre-existing pulmonary illnesses such as these are at high risk for complications of influenza and have limited antiviral drug options, due both to side effects and possible drug resistance. More information about the study may be found at www.clinicaltrials.gov.
DAS181 is a novel broad-spectrum, host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI) and has shown preclinical activity against numerous strains of influenza and parainfluenza virus. DAS181 blocks entry of these viruses into cells of the respiratory tract. In November 2009, NexBio announced data at the annual American College of Allergy, Asthma, and Immunology meeting demonstrating anti-asthma activity of DAS181 in multiple animal models of asthma.
NexBio is currently conducting a Phase II trial for the treatment of otherwise healthy adults with influenza using DAS181, funded by NIAID. More information on this trial may be found at http://www.das181flustudy.com/ as well as at www.clinicaltrials.gov. The company has previously completed two Phase I trials with increasing single and multi-dose regimens of DAS181 in healthy subjects. The drug was well tolerated and there were no serious adverse events.
"This new trial continues our collaboration with the NIH for the development of DAS181, with the clinical focus now moving to the development of DAS181 not only in healthy adults but also in high-risk populations," commented Dr. Ron Moss, NexBio's Executive Vice President of Clinical Development & Medical Affairs. "We are very fortunate to have this study conducted at the NIH Clinical Center. While this first step in evaluating the effects of DAS181 in a high-risk population is in those with airway disease, it is our ongoing goal to assess DAS181's potential use in additional high-risk populations, for whom novel influenza antivirals are needed."
NexBio, Inc. is a privately held clinical-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. DAS181 (Fludase®) is an investigational drug undergoing phase II clinical development, directed to the treatment and prophylaxis of influenza-like illness caused by any and all strains of influenza, including pandemic strains, and parainfluenza (which may cause serious respiratory illness similar to influenza and for which there is no approved vaccine or therapeutic). DAS181 is a host-targeted inhaled recombinant fusion protein that inactivates viral receptors on the cells of the human respiratory tract, thereby treating and preventing viral infection. The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, under BAA Contract HHSN266200600015C and grant U01-AI070281. Sepcidin(TM), invented and developed by NexBio, is a parenteral protein at lead optimization stage, directed to the treatment of viral hemorrhagic fevers, bacterial biothreat agents and sepsis. TOSAP® is a technology invented and developed by NexBio and used to formulate DAS181 for inhalation, as well as to make microparticles from virtually any type of molecule. TOSAP is offered for the formulation of compounds of partners under license. SAFRANTM is a technology invented and developed by NexBio, used to formulate siRNA for parenteral delivery.
For more information about NexBio, please visit http://www.nexbio.com
* FDA has yet to approve the name Fludase.
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.