NexBio(R) and Weill Cornell Medical College Publish Preclinical Study Showing DAS181 (Fludase(R)*) Anti-Influenza Drug Inhibits Parainfluenza Virus

SAN DIEGO, June 18 /PRNewswire/ -- NexBio, Inc. announced today the publication of a "Major Article" in the Journal of Infectious Diseases of a preclinical study showing that treatment with DAS181 (Fludase®) inhibits infection with multiple human parainfluenza virus (HPIV) strains.  DAS181 is a broad spectrum host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI).  Earlier publications have shown DAS181's preclinical activity against numerous strains of influenza (IFV) including Pandemic Influenza A(H1N1) and highly pathogenic avian H5N1.

Parainfluenza viruses are a common and underappreciated cause of respiratory viral infection in people of all ages and a potentially lethal infection in individuals with weakened immune systems and other underlying illnesses.  There is currently no approved drug or vaccine for any HPIV strain.  Both HPIV and IFV gain entry to human respiratory epithelial cells by attaching to sialic acid receptors.  DAS181 works by inactivating these receptors, thereby preventing or containing infection.  As it is difficult to distinguish clinically between infection with IFV and HPIV, a broad-spectrum respiratory antiviral agent that treats all IFVs and HPIVs equally well would be highly desirable in the clinical setting.

In the paper entitled "A Recombinant Sialidase Fusion Protein Effectively Inhibits Human Parainfluenza Viral Infection In Vitro and In Vivo" studies were conducted using DAS181 with HPIV1, HPIV2 and HPIV3 strains, both in cell-based systems and in cotton rats. DAS181 was shown to significantly curtail HPIV infection and to do so as efficiently as for inhibiting IFV.

"Therapies for parainfluenza are urgently needed. Development of effective antiviral drugs and vaccines for HPIV has lagged far behind IFV, despite the recognized impact of these diseases in children and the more recently recognized importance of these pathogens in the adult population, particularly the elderly, immunocompromised, and patients with underlying airway disease," commented Dr. Anne Moscona, Professor of Pediatrics and of Microbiology and Immunology, Vice Chair for Research of Pediatrics, and Chief of Pediatric Infectious Diseases at Weill Cornell Medical College, and co-corresponding author of the paper with Dr. Fang Fang, NexBio's President of R&D.  "DAS181, if shown effective in clinical studies, could be a promising treatment for HPIV," Dr. Moscona added.

Earlier publications have described DAS181's activity for Pandemic Influenza A(H1N1) and highly pathogenic avian H5N1, as well as for IFV resistant to neuraminidase inhibitors (NAIs) such as Tamiflu® (oseltamivir).  Unlike NAIs or vaccines, which both target the virus ("pathogen target"), DAS181 works by inactivating the human receptors ("host target") to which viruses bind; thus, drug resistance may be less likely to emerge compared with currently-available antiviral drugs.  In addition, NexBio has recently presented data from three independent studies in animal models of asthma, done with academic collaborators, demonstrating DAS181's potential benefit for airway diseases.

DAS181 is currently being studied for influenza in a human phase II clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID, part of the National Institutes of Health, NIH) and monitored by an independent Data Safety Monitoring Board. This investigational drug is also being studied in patients with the respiratory conditions asthma and bronchiectasis in a trial conducted by NIAID at the NIH Clinical Center.  This latter trial examines the effects of DAS181 in subjects with well-controlled or stable pulmonary disease.  More information is available at www.clinicaltrials.gov.

The work at Weill Cornell was supported by a Public Health Service grant from the National Institutes of Health (NIAID) to Anne Moscona, a March of Dimes Research Grant to Anne Moscona, and an American Lung Association Research grant to Matteo Porotto.

ABOUT NEXBIO

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.  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™, 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®, a technology invented and developed by NexBio, is 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.

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

* 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.

SOURCE NexBio, Inc.